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NATIONAL INSTITUTE ON DRUG ABUSE(NIDA)
The mission of the NlDA is to lead the
nation in bringing the power of scienceto bear on drug abuse and addiction,
through support and conduct of researchacross a broad range of disciplines andby ensuring rapid and effective
dissemination and use of research results
to improve prevention, treatment, andpolicy. For additional information about
areas of interest to the NIDA, please
visit our home page at
http://www.nida.nih.gov/.
Phase II Competing Continuation Awards
(See http://grants.nih.gov/grants/guide/pa-files/PA-
03-154.html.)
NIDA will accept competingcontinuation Phase II SBIR/STTR grant
applications from Phase II SBIR/STTR
awardees to continue the process ofdeveloping products that require
approval of a Federal regulatory agency.
Such products include, but are notlimited to: medical implants, drugs,
vaccines, and new treatment or
diagnostic tools that require FDAapproval. This continuation grant should
allow small businesses to get to a stage
where interest and investment by third
parties is more likely.Please contact Dr. Cathrine Sasek
(contact information provided below)
before beginning the process of puttingan application together. Prospective
applicants are strongly encouraged to
contact NIH staff prior to submission of
a type 2 competing continuationapplication. Prospective applicants are
strongly encouraged to submit to the
program contact a letter of intent thatincludes the following information:
Descriptive title of the proposed
research
Name, address, and telephonenumber of the Principal Investigator
Names of other key personnel
Participating institutions
PA, RFA or Solicitation Number
(e.g., PA-03-154; PHS 2004-2)
Although a letter of intent is not
required, is not binding, and does not
enter into the review of a subsequentapplication, the information that it
contains allows NIH staff to estimate the
potential review workload and plan thereview. It is expected that only a portion
of NIDA SBIR/STTR Phase II awards
will be eligible for a competing
continuation grant.The following examples would make
appropriate topics for proposed SBIR or
STTR Phase II competing continuationprojects. These are meant for illustrative
purposes only and are not exclusive of
other appropriate activities.Research and development efforts can be
focused on medications for the treatment
of cocaine, methamphetamine, and other
stimulant abuse, as well as towardsopiate, cannabis, PCP and club drugs.
The medications under development
should be targeted towards attainment ofabstinence, maintenance, and/or relapse
prevention. Preclinical studies, including
pharmacology and toxicology,
beyond those conducted under theinitial SBIR Phase I and Phase IIgrants. The studies conducted
under the previous grants should besufficient to provide a sound
rationale for continued development
of the entity or entities.
Completion of studies as requiredby the FDA for an IND application.
Human laboratory clinical trials to
determine a medication's safetyprofile, metabolism, cardiovascular
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effects, interaction with drugs ofabuse, etc.
Clinical studies to assess the
efficacy of the medication underdevelopment.
Cathrine Sasek, Ph.D.
National Institute on Drug Abuse6001 Executive Boulevard
Room 5230, MSC 9591Bethesda, Maryland 20892-9591
(301) 443-6071, Fax: (301) 443-6277
Email: [email protected]
Division of Treatment Research andDevelopment
The NIDA Division of Treatment
Research and Development (DTR&D)
supports research aimed at thedevelopment and testing of
pharmacological and behavioral
treatments for drug abuse and addiction.This includes the identification,
evaluation, development, approvability,
and efficacy testing of new andimproved pharmacotherapeutic agents,
as well as the testing of marketed
medications, and of behavioral
treatments used alone or integrated with
medications. The DTR&D also advancesa human neuroscience research and
training program focused onunderstanding the neurobiological
substrates of drug abuse and addiction
processes.A. Chemistry and Pharmaceutics
Branch (CPB). The CPB supportsresearch in the design (includingmolecular modeling and structure-
activity relationship studies) andsynthesis of novel compounds,
formulation development, bioanalyticalmethods development, and
pharmacokinetics/ pharmacodynamicsaimed at the discovery anddevelopment of new medications for
treating drug addiction. Areas that maybe of interest to small businesses
include, but are not limited to researchrelated to the design and development
of new compounds and improved drugproducts (drug delivery) for thetreatment of drug addiction:
1. Synthesis of new chemical
compounds that would havepotential as treatment agents forthe medical management of
stimulant (e.g., cocaine,methamphetamine, or nicotine)
addiction. Consideration should begiven to the design of partial
agonists or pure antagonists thatdiminish the reinforcing effects ofstimulants, as well as full agonists
that could function to normalizephysiological activity following
discontinuation of stimulant use.
Compounds of interest include
those that are designed to affect
dopaminergic (i.e., D1 agonists, D3agonists and D3 antagonists)activity, CRF antagonists,
compounds affecting glutamateactivity, GABAergic activity, smallmolecule neuropeptide antagonists
and compounds acting throughother mechanisms for which
justification has been supplied.
2. The development of combinatorial
libraries for discovery of drugaddiction pharmacotherapies.
3. Synthesis of new chemicalcompounds with potential for the
treatment of opioid dependenceand/or craving. Compounds which
may prevent relapse to opiate usefollowing a period of drugabstinence are of special interest.
Kappa antagonists are of particularinterest.
Richard Kline, Ph.D.(301) 443-8293
Email: [email protected]
4. Development of new approachesfor the administration of potentialaddiction treatment drugs with poor
bioavailability.
5. Development of controlled release
dosage forms for addictiontreatment medications in order to
maintain therapeutic drug levels forextended periods of time to
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alleviate compliance problemsassociated with addiction
treatment.
Moo Park, Ph.D.
(301) 443-5280
Email: [email protected]. Medications Discovery and
Toxicology Branch (MDTB). TheMDTB supports research on thedevelopment of preclinical behavioralmodels (e.g., of craving, drug-seeking
behavior, dependence, or relapse),biochemical assays, gene expressional
assays and electrophysiologicalmethods to identify and characterize
new medications to treat substanceabuse, as well as pharmacologicalscreening of novel compounds to
identify potential drug abusemedications. The Branch also supports
research on toxicity studies of potentialmedications for the treatment of
substance abuse, and interactions ofpotential treatment medications withabused substances. Areas that may be
of interest to small businesses include,but are not limited to development ofnew methods for discovery ofmedications useful in treating drugaddiction. Of special interest would bethe development of new animal models
of addiction, incorporating establisheddrug self-administration techniques thatshow increased relevance to the
clinical setting. Development ofrelevant biochemical or
electrophysiological screening methodsis also encouraged.
Jane B. Acri, Ph.D.(301) 443-8489
Email:[email protected]. Behavioral Treatment Development
Branch (BTDB). The BTDB supportsresearch on behavioral treatments and
combined behavioral andpharmacological treatments for drugabuse and dependence. Behavioral
treatments include psychotherapies,behavior therapies, family therapies,
group therapies, counseling strategies,rehabilitative techniques, brief
behavioral interventions, therapeuticcommunity treatments, and otherpsychosocial treatments. Research on
these treatments may be carried out inany setting, including both academic
and community or real-world settings.Areas that may be of interest to smallbusinesses include, but are not limited
to:
1. Behavioral Strategies for
Increasing Compliance in TakingTreatment Medication. Research todevelop and to evaluate strategiesto induce recovering addicts to take
medication for a prolonged time,especially antagonists such asNaltrexone; to induce HIV infected
drug users to comply with medicaltreatments (HAART) in drug abuse
treatment settings; or to adaptexisting behavioral strategies to
increase patient compliance andcooperation in long-term treatment
for drug abuse or for diseasesassociated with drug abuse suchas tuberculosis or hepatitis. An
important consideration should becost and practicality of use in
actual clinical practice or in anaftercare program. The product of
such research might be a manual,which describes the behavioralstrategy, and its implementation by
treatment staff or scientific dataregarding evaluation.
2. Integration of Behavioral Therapiesand Pharmacotherapies.Development and testing ofintegrated therapeutic approaches
for individuals who abuse variousdrugs, includingmethamphetamine, cocaine,
nicotine, and opioids; in additionthis may include individuals with
co-occurring substance abuse andmental disorders, since effective
treatment of both disorders maylead to improved treatment
outcomes. Integrated behavioraltherapies and pharmacotherapiesmay enhance the efficacy of both
types of therapeutic interventions.For instance, the maintenance and
detoxification of heroin addictscould perhaps be optimized by the
integration of distinctive behavioraltherapies devised specifically for
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opioid agonists, antagonists orpartial agonists determined by the
heterogeneity of the subgroup ofaddicts and the pharmacologicaldifferences of the medications.
Integration of medications andbehavioral therapies could possibly
enhance compliance with
medication regimens, increaseretention allowing pharmacologicaleffects to occur and preventrelapse to drug abuse and
addiction.
3. Behavioral Treatment Research forDrug Abuse and Addiction inPrimary Care. Recent research hasshown that physicians and otherclinicians often fail to recognize
drug abuse or addiction amongtheir primary care patients. In
addition, a significant number ofthese clinicians reported that theydid not know how to intervene with
their patients if drug abuse oraddiction was suspected. Drug
abuse related illnesses andmorbidity often occur in adults and
may have begun in adolescence.However, very little research hasbeen done to develop or test
behavioral treatment approachesor combined pharmacological and
behavioral treatments for drug
abuse and addiction in primarycare settings. The objectives of thisinitiative are to encourage researchon the development and testing of
innovative brief behavioraltreatment approaches, alone or in
combination with pharmacologicaltreatments that may be used in
various primary care patientpopulations and primary caresettings. Other goals of this
research initiative are to encourage
additional research on thedevelopment and evaluation ofculturally sensitive screening and
assessment instruments for use inprimary care; and to encourageresearch on the transportability of
efficacious behavioral treatments toprimary care settings, as well as
research on science-based trainingapproaches for changing primary
care clinicians' behaviors regardingtheir recognition and intervention
with drug abusing or addictedpatients. While motivationalenhancement approaches for some
drug abusing populations havebeen found to be effective, this
behavioral approach has not been
widely used in primary care.
4. Woman and Gender Differences inthe Provision of BehavioralTreatments, and HIV/AIDS RiskReduction Approaches. Developand evaluate specific behavioral
treatment approaches targetingdrug-addicted women. This may
include behavioral therapies, skillstraining techniques, counseling
strategies, and HIV and otherinfectious disease behavioral risk
reduction strategies. This may alsoinclude development and testing oftraining materials that specifically
address women and genderdifferences in drug addiction
treatment to promote effective useof research-based treatment
approaches. Training materialsmay involve treatment manuals,training videos, CD ROM or DVD
technologies, Internet or computerbased programs to manage
aspects of treatment
administration, or other innovativeeducational strategies for healthprofessionals using newtechnologies.
5. Transporting BehavioralTreatments to CommunityPractitioners. There is a need foreffective methods of transferring
behavioral therapies found to beeffective in clinical trials to clinical
practice. Cognitive-behavioraltherapy, operant behavioral
therapy, group therapy, and familytherapy are among the therapiesthat have been shown to be
efficacious in a highly controlledsetting and may be helpful
treatment approaches incommunity treatment programs as
well. However, communitypractitioners may have been
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trained using other approaches andmay not have been exposed to
these scientifically-basedapproaches. This is a call forproposals that examine
mechanisms to transfer effectiveresearch-based drug abuse
treatment information and skills-
based techniques to practitioners inthe community. This may involvethe development and testing ofinnovative training materials and
procedures to use in the training ofcommunity practitioners to skillfully
administer these treatments,including the development of highly
innovative technology transfer andcommunication approaches.Research testing the
transportability of empirically
supported therapies to thecommunity is an importantcomponent of the Behavioral
Therapies Development Program.
There is also a need for the
development of educationalmethods to train non-drug abuse
health care workers in relating todrug abusers; eliciting medicalhistories regarding past or present
drug abuse; recognition of thesigns and symptoms of drug
abuse; identification of those at
high-risk for HIV and other drugabuse related medical problemssuch as tuberculosis or hepatitis.Development and validation of a
drug abuse screening instrumentwhich can be administered by
primary health care providers, andtraining in administering such an
instrument.
6. Using Telemedicine to DisseminateDrug Addiction Research Findingsto Primary Health Care Providers.
Telemedicine programs are beingused in urban medical centers torapidly disseminate science-based
information on new medicaltreatments. In addition,
approximately one-third of the ruralhospitals are now using
telemedicine to improve patientcare. Health care professionals
need science-based information ondrug abuse prevention and
treatment. Research to developand evaluate telemedicineprograms to transport science-
based information on drugaddiction to the primary health care
community is encouraged.
7. Developing, Evaluating, andTransporting Culturally SensitiveBehavioral Therapies for Racialand Ethnic Minorities. Minoritypopulations are disproportionatelyaffected by the consequences of
drug abuse. Research to developand evaluate behavioral treatments
that are culturally sensitive andrelevant for diverse racial and
ethnic minority populations isencouraged. This may include
studies of behavioral treatments,alone or in combination withpharmacological treatment, or
studies of behavioral strategies forincreasing adherence to taking
medications. In the developmentand evaluation of the behavioral
treatment, attention needs to bedirected at examining medical,social, and cultural factors that may
influence adherence to thebehavioral treatment approach and
treatment outcome. Also, little is
known about the transportability ofefficacious behavioral treatmentsfor minority populations. Researchis needed on how to transport
science-based treatments tovarious racial/ethnic populations.
Dorynne Czechowicz, M.D.(301) 443-0107
Email: [email protected]. Behavioral Therapy Development.
Development of new or refinementof existing psychotherapies,
behavioral therapies, skills trainingtechniques or drug counseling
strategies for the treatment of drugabusers/addicts. Incorporation ofHIV risk reduction strategies as an
integral component in routinecounseling or other behavioral
interventions. This would includethe development of: therapy
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manuals, to define exactly what thetherapy is and how to administer it
optimally; competence andadherence scales, to evaluate theextent to which therapists and
counselors are actually providingthe therapy intended; process
measures, to measure various
aspects of the therapeuticinteraction; and measures of theintegrity and fidelity of the therapy.The following are of particular
interest:
a. Development of behavioral
therapies or components ofsuch therapies that are based
on developments and findingsfrom the basic behavioral or
cognitive sciences.
b. Discrete therapy componentsthat address specific problemscommon among drug addicted
individuals and that can beimplemented in conjunctionwith other therapeutic services.
For example, an investigatormay wish to develop a four
session, highly focused, jobseeking skills module that can
be easily implemented by awide range of practitioners toeffectively increase appropriate
job seeking behavior. Otherexamples include, but are not
limited to, modules to engageambivalent drug dependent
individuals in treatment,modules to increaseassertiveness in female drug
addicts who feel pressured byothers to use drugs, or to
incorporate effective HIV riskreduction techniques.
c. Therapies designed specifically
to engage and retainindividuals in treatment,especially those at high risk for
HIV. An example could be atherapy that is: (1) sensitive tothe motivational level of the
client; (2) is specificallydesigned to respond to the
needs of the individual,whatever his or her
motivational level might be;and (3) actively works toincrease an individual's desire
to remain in treatment.
d. Therapies designed tointervene with understudiedpopulations including users of
drugs such as MDMA andother club drugs, marijuana,
and inhalants, as well aspersonality disordered drug
abusers.
e. Therapies for drug abusers
who are not yet dependent ondrugs to reduce risk of
escalation to dependence andtherapies for drug abusers whohave not considered or claim
little interest in seeking
treatment for their drugproblems. For thesepopulations treatments are
needed which interest andengage the potential client andintervene with them.
Treatments which participantsin their natural environment,
such as treatments deliveredover the Internet or in
neighborhood settings such aschurches and recreationcenters are desired.
Lisa Simon Onken, Ph.D.(301) 443-0107
Email: [email protected]. Development of HIV Risk
Reduction Interventions. Researchto develop and evaluate behavioralstrategies to reduce HIV riskbehaviors in HIV-positive and HIV-
negative substance abusingtreatment populations. Risk
reduction interventions should bespecially adapted to patients age,
gender, cultural background andpotential cognitive impairments andshould address compliance with
medical regimens. The product ofsuch research might be
educational materials, such asmanuals or videotapes that
describe the intervention and itsimplementation by treatment staff.
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10. Complementary and AlternativeTherapies (CAT) for Drug AbuseTreatment. Research isencouraged on complementary andalternative interventions for drug
abuse treatment. CAT interventionscould be the sole treatment or
could be adjunctive strategies to
enhance the therapeutic potency ofexisting drug abuse treatments. Anexample of an adjunctive CATintervention might be where the
intervention reduces withdrawalsymptoms thus enhancing
retention in treatment. Includedwould be interventions that are
commonly used in real worldtreatment settings, but whosetherapeutic efficacy has not been
scientifically demonstrated. Such
interventions include acupuncture,bioelectrical stimulation, exercise,biofeedback, meditation, among
others. The product of thisresearch might be a manual orvideo, which illustrates the
intervention and how it isimplemented by treatment staff.
11. Translation of Cognitive andAffective Neuroscience FindingsTowards Development ofBehavioral Treatments. Recentstudies using neuroimaging and
neuropsychological evaluationsprovide ample evidence thatchronic drug use is associated withneuroanatomical changes that alter
cognitive function and the ability toregulate affective states. Further,
these changes vary over time andmay depend on the current state of
the individual (e.g., acuteadministration of one or moredrugs; during initial vs protracted
abstinence). Such comorbid
conditions make it difficult for manychronic drug users to engage inand participate meaningfully in
efficacious behavioral drugtreatments. However, knowledgefrom neuroimaging and
neuropsychological studies has notyet been utilized to benefit the
patient. In addition, knowledgeabout fundamental cognitive and
affective functioning even in theintact brain, typically has not led to
tools that can be used for treatingsubstance abuse. Thus, researchthat integrates basic research
findings on cognition (e.g.,decision-making, problem-solving,
learning, memory, attention,
motivation) and affect (e.g.,anxiety, anger, depression) in thefollowing areas are encouraged:Development of interventions to (a)
reduce the negative impact ofcognitive dysfunction and affective
dysregulation on drug useoutcome; (b) prevent relapse; (c)
reduce the severity and course ofthe dysfunctions; (d) improvespecific areas of cognitive and
affective functioning; and (e)
improve daily functioning inaddition to reducing clinicalsymptoms. Other goals of this
initiative are to: Develop reliableand valid methods for assessingbasic cognitive and affective
processes as part of clinicaldiagnosis; evaluate cognitive and
affective functioning as indicatorsof risk for exacerbated drug use
during treatment or for developingother disorders; determine if andhow current efficacious treatments
rehabilitate altered cognitive andaffective functioning; modify and
test current efficacious treatmentstailored to the needs of cognitively
impaired individuals.
Mary Ann Stephens, Ph.D.
(301) 443-0107
Email: [email protected]. Incorporating Smoking Cessation
in Drug Abuse Treatment.Research is encouraged to developand test behavioral treatments for
nicotine-addicted individuals whoalso are addicted to othersubstances, such as heroin,
cocaine, methamphetamines andalcohol. Prevalence of cigarette
smoking is extremely high amongdrug dependent individuals
attending drug treatment. Manytreatment providers are reluctant to
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address smoking cessation withclients either because they believe
that substance abusers are notinterested in quitting or becausethey fear smoking treatment will
have a negative impact on drugabuse treatment outcome.
However, studies have shown that
many drug abuse clients areinterested in quitting smoking andthat the concurrent treatment oftobacco dependence and other
drug dependencies does notthreaten abstinence and might
even assist in maintaining it.Research is needed to develop and
test smoking cessation treatmentsthat can be incorporated intotreatments for illicit drugs of abuse.
13. Developing Treatments for
Smokers with Comorbid Disorders.Research is encouraged thatfocuses on the development,
refinement, and testing ofbehavioral treatments for smokers
with psychiatric comorbidity, suchas depression, schizophrenia, or
anxiety disorders. Smokingprevalence is very high inindividuals with psychiatric
disorders. These populationsgenerally respond poorly to
traditional smoking cessation
treatments. Research is needed todevelop and test innovativebehavioral and combinedbehavioral and pharmacological
treatments that address the uniqueneeds of these individuals.
Ms. Debra Grossman(301) 443-0107
Email: [email protected]. Development of New or Improved
Addiction Assessment Measuresand Procedures. Research directed
at the improvement of a currentlyavailable measure or the design of
a new psychosocial, social orenvironmental measureappropriate for use in the clinical
assessment of substance abusingpopulations. Special consideration
should be given to a specificscreening or diagnostic tool, or to a
specific measure of treatmentreadiness, treatment compliance,
service utilization, therapeuticprocess or drug treatmentoutcome. The NIDA DTR&D
supports research aimed at thedevelopment and testing of
pharmacological and behavioral
treatments for drug abuse andaddiction. This includes theidentification, evaluation,development, approvability, and
efficacy testing of new andimproved pharmacotherapeutic
agents, as well as the testing ofmarketed medications, and of
behavioral treatments used aloneor integrated with medications. TheDTR&D also advances a human
neuroscience research and training
program focused on understandingthe neurobiological substrates ofdrug abuse and addiction
processes.
15. Behavioral Therapies for Pre-Adolescents and Adolescents.Behavioral therapies for pre-
adolescents and adolescents thatincorporate HIV risk reductioncounseling as an integral
component of the treatment. Thisincludes the development of new,
or refinement of existing
psychotherapies, behavioraltherapies, and counseling (groupand/or individual). This alsoincludes the development and
testing of manuals as well as othercreative, interactive approaches for
therapy delivery that may considerdifferent settings for delivery, such
as primary care, school-basedhealth programs, juvenile justicesettings, etc. Also the behavioral
treatments should be culturally and
gender sensitive.16. Behavioral Therapies for Couples
and Families. This includes thedevelopment of new psychotherapyapproaches, the modification or
testing of existing behavioraltreatments, and the design and/or
testing of innovative clinical trainingand supervision methods for
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dissemination of efficacioustreatments to community settings.
Treatments that target domesticviolence or other forms ofinterpersonal abuse along with
substance abuse are encouraged.
17. Behavioral Therapies for Groups.
This includes the development ofnew psychotherapy approaches,
the modification or testing ofexisting behavioral treatments, and
the design and/or testing ofinnovative clinical training andsupervision methods for
dissemination of efficacioustreatments to community settings.
Examples of relevant projects are:traditional group therapies, such as
12-step and therapeutic communityapproaches, and newer group
therapies such as cognitive-behavioral and acceptance-oriented approaches; groups for
various populations, such asadolescents, adults, couple and
family groups, gender-specificgroups, and groups tailored for
racial or ethnic minoritypopulations. Of particular interestare projects that address the recent
findings suggesting possiblecontraindications of group
treatments for some populations
(e.g., delinquent adolescents), or insome formats (e.g., less-structured,emotion-focused grouptreatments).
18. Behavioral Therapies Drawing fromStress Research or Stress-Management Interventions.Projects are encouraged that apply
concepts from stress research(such as appraisal, coping, and
social support) to drug abuse ininnovative ways, or that test the
extent to which stress-management interventions can beapplied to the treatment of drug
abuse and interventions to reducerisk of HIV and other infectious
diseases. Examples of stress-management techniques that may
have novel application to drugabuse and HIV risk include
techniques that teach problem-solving and affect-management,
restore ones sense of purpose andmeaning, prevent burnout in theface of chronic stressors, increase
self-efficacy for managing stress,inoculate against stressors, train
relaxation and meditation,
intervene during crises, enlistsocial support and system support,and others.
Melissa W. Racioppo, Ph.D.(301) 443-0107, Fax: (301) 443-6814
Email: [email protected]. Modifying Efficacious Behavioral
Treatments to be CommunityFriendly. Several behavioralinterventions have been found to
be efficacious for the treatment ofdrug addiction. However, there are
barriers to implementation ofbehavioral therapies in community-
based settings. Communitysettings that treat drug addictedindividuals are reluctant or
unwilling to adopt theseinterventions for a variety of
reasons. Reasons thatscientifically-based behavioral
treatments are not accepted bycommunity providers could include
the excessive cost ofimplementation, the length of timefor administration of treatment,
inadequate training available fortherapists and counselors,
treatments not shown to begeneralizable for different patient
populations or for polydrug abusingpopulations, etc. Research aimedat modifying efficacious behavioral
treatments to make them moreacceptable to community settings
is needed. Settings might include,drug abuse treatment facilities,
primary care, managed care, andthe criminal justice system.Examples of possible studies are
those that are designed to reducethe cost of implementation of
treatments, reduce the time ofadministration of treatments, aid in
training of therapists, counselors
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and nurses, adapt individualtherapies for group situations, etc.
20. Innovative Technologies for DrugAbuse Treatment, HIV RiskReduction, and Training Clinicians.Relevant research would bedirected at the development and
evaluation of innovativetechnologies to treat substance
abuse, enhance adherence tomedications, and/or reduce risk for
HIV infection or transmission.Approaches should be capable ofbeing readily incorporated at
reasonable cost into varioustreatment settings. Areas of
interest include Internet-basedtreatment or training programs,
CD-ROM technology, audiodelivery devices, photo therapeutic
instruments, and hand-heldcomputers. Also of interest arecreative approaches for
disseminating science-basedbehavioral treatments and for
training therapists to usescientifically based treatments for
drug abuse and addiction. Suchapproaches might include Internet-based education, interactive
computer programs, telemedicine,etc. Finally, approaches which
apply therapies with evidence of
efficacy through new media suchas web-based platforms, overemail, or through chat rooms andbullet boards are also desirable.
21. Virtual Reality Applications for DrugAbuse Treatment ProviderTraining. Recently virtual realitysimulations have been used to train
medical personnel in demandingmedical procedures such as
microsurgery techniques. Virtualtraining allows trainees to gain
familiarity with both theenvironment in which services aredelivered as well as the
intervention techniques without thedanger of mistakes impacting live
patients. Virtual reality interfacescan assess skill acquisition and
provide detailed feedback duringprocedures to help trainees correct
mistakes or avoid making themaltogether. In the drug abuse field,
training and dissemination effortshave been hampered by a dearthof knowledge about ways to
conduct dissemination. Althoughtrainees often practice on actual
clients, this approach has
drawbacks including its reliance onthe client or participants scheduleand willingness to participate intraining sessions and potential
danger to the client or if theintervention is delivered incorrectly.
Libraries of virtual realitysimulations of drug users in
treatment or virtual patients areneeded to provide experientialtraining for treatment providers
without relying on existing patients.
This will help facilitate the rapidand effective dissemination ofproven treatment strategies.
Cecelia McNamara, Ph.D.(301) 443-0107, Fax: (301) 443-6814
Email: [email protected]. Clinical Neurobiology Branch (CNB).
The CNB supports research on thebiological etiology (determining the
biological basis for vulnerability to drugabuse and progression to addiction,
including studies on individualdifferences and genetics) and clinicalneurobiology of addiction (exploring
alterations of the structure and/orfunction of the human central nervous
system following acute or chronicexposure of drugs of abuse), and the
neurobiology of development(neurobiological effects of drugs ofabuse and addiction during various
stages of development and maturation,effects of drug exposure on
neurobiological processes,development of methodologies and
refinement of techniques used inpediatric neuroimaging). The Branchalso supports investigations on the
cognitive neuroscience of drug abuseand addiction, the neurobiology of
treatment, neuroAIDS, and human painand analgesia. Areas that may be of
interest to small businesses include,but are not limited to:
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1. Development of Novel Approachesin Human Neuroscience.Development of innovative,noninvasive research methods ornovel approaches are needed to
identify various neurobiologicalmarkers of brain alterations in
humans induced by acute or
chronic exposure drugs of abuse.This may include the identificationof neurobiological (includinggenetic) markers that might be
associated with risk for, orresilience to drug abuse and
addiction. Of particular interest arenoninvasive methods (e.g., brain
imaging) that could be used todetermine the effects of drugabuse/ addiction treatments on
neurobiological systems in an
attempt to understand theneurobiological processesunderlying therapeutic efficacy.
In recent years, there has been anincrease in studies employing
functional magnetic resonanceimaging (fMRI) to understand brain
processes and functional neuronalsystems. In particular, theseneuroimaging techniques are being
used to probe how drugs of abusealter brain functioning.
Consequently, there is a need for
the development of stimulusgeneration hardware to be usedwithin an fMRI magnet that candisplay stimuli important in drug
studies. As the studies of brainfunction become more
sophisticated, task-relatedassessments of brain activation are
increasingly important. Shieldedgoggles or other types of stimulus-generating hardware and software
are necessary for presentation, for
example, of neurocognitive tasks,drug-related images for theinduction of craving, or other
virtual reality types of dynamicstimuli important in studies of drugabuse and addiction. Responses to
this type of stimulation then couldbe correlated with brain measures
using neuroimaging techniques.These types of studies will provide
new insights into drug-brain-behavior interactions.
Development of the human centralnervous system and how drugs of
abuse perturb this process is ofgreat interest. Little is currentlyknown about the effects of
exposure to drugs of abuse, eitherprenatally or during childhood or
adolescence, on the developmentof the human nervous system.
Further, the application of newlyemerging technologies (such asneuroimaging) to these populations
presents unique challenges due tothe fact that the central nervous
system, and its capabilities, arechanging rapidly. The development
of novel techniques, or therefinement of existing methods, to
provide direct noninvasivemeasures of brain structure and/orfunction that are adapted
specifically for use in pediatric andadolescent populations is strongly
encouraged. Also, neurocognitiveand other neurobehavioral tasks foruse in these populations, especially
where they can be designed toprobe underlying neurobiological
processes, need to be developed.
Joseph Frascella, Ph.D.
(301) 443-4877Email:[email protected] Stanford, Ph.D.(301) 443-4877
Email: [email protected]. Virtual Reality for the
Neurobiological Study of Drug-Brain-Behavior Interactions andDrug Abuse Treatment. VirtualReality (VR) is an emergingtechnology useful in a variety of
research-related, therapeutic andinstructional settings. By immersing
a persons senses in a syntheticworld or Virtual Environment (VE)
that characterizes VR, a highlyflexible and programmable set ofstimuli can be used to enhance the
standard approaches used inassessment of neurobiological and
neurobehavioral processes.
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Collection of real-time data andbulk data recording can provide a
correlation of a stimulus referencesignal with simultaneouslycollected fMRI scanner and
physiological data over time. Unlikemost computer access systems
that accept only one or two modes
of precise and/or discrete input at atime, VR systems have thepotential to monitor movement oraction from any, or many,
neurobiological functions at once.In addition, the multimodal
feedback inherent in VR provides away to vary nonvisual stimulus
components (e.g., resistance,temperature, pitch) in a way that isimpossible to achieve via standard
computer systems. Finally, VR
systems provide a bypass forkeyboard entry or directmanipulation environments (e.g.,
pointing instruments like themouse), by allowing themanipulation of multi-sensory
representations of entireenvironments by natural actions
and gestures.
VE can provide a completely
controlled, noninvasive, safe andalternative methodology for a
variety of important studies of drug
abuse and addiction. For example,VR allows for the presentation of avariety of complex, multi-sensorystimuli for neurocognitive tasks or,
alternatively, the dynamic stimuliimportant for producing drug-
related images for the induction ofcraving. VR can also be tested as
an alternative to traditionalbehavioral therapies in thetreatment of drug abuse.
Responses obtained as a result of
the above can then be correlatedwith brain measures using state-of-the-art neuroimaging techniques.
We, therefore, invite studiesemploying VR, especially to probebrain processes in drug
abuse/addiction combined withneuroimaging methods or to be
developed or applied as a potentialtreatment for substance abuse.
Ro Nemeth-Coslett, Ph.D.(301) 402-1746
Email: [email protected]. Development of Interactive
Computer Applications forNeuropsychological/Neurocognitive Assessment toDetermine Functional Brain Deficitsin Acute and Chronic DrugAbusers. In addition, aneurobehavioral test battery to
assess otherneurobehavioral/neurocognitive
deficits resulting from drugabuse/addiction is encouraged. Ofparticular interest is the
development of such assessmentsfor use in children and adolescents
exposed to drugs of abuse to betterdefine and understand the effects
of early exposure on brain functionand development (fordevelopmental issues, contact
Larry Stanford, Ph.D.).
Steven Grant, Ph.D.
(301) 443-4877
Email: [email protected] Stanford, Ph.D.(301) 443-4877
Email: [email protected]. Development of Ligands for Brain
Imaging. Development of novelradioligands for PET and SPECT
imaging in human brain formolecular targets (e.g., receptors,intracellular messengers, disease-
related proteins) is of broad interestto the neuroscience and drug
abuse research community. Theprimary application of these
radiotracers will be in basicneuroimaging research. Ultimately,these radiotracers may also be
used as potential biological
markers and surrogate endpointsfor translational and clinicalresearch, drug discovery and
development, and clinical trials.The scope of the projects mayencompass pilot or clinical
feasibility evaluation in pre-clinicalstudies, model development, or
clinical studies. Alternatively, the
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focus may be on research anddevelopment of new technologies
for radiotracer development.
Steven Grant, Ph.D.
(301) 443-4877
Email: [email protected]. Novel Approaches in the Clinical
Neurobiology of Drug Addiction.Given the array of interdisciplinarysolutions across the NIH for avariety of existing conditions, NIDA
has a strong interest in novelapproaches, devices and
strategies, which have not, untilnow, focused on the drug abuse
arena. We, therefore, inviteproposals to determine which, ifany, pre-existing assessments,
research tools and/or interventionstrategies can be effectively
applied to issues specificallyrelated to neurobiology of human
drug abuse and the addictionprocess (e.g., neurobiologicmechanisms underlying drug
abuse or addiction,neurobiologic/genetic determinants
of risk/protective factors, theprevention of initiation, the onset of
dependence, the longevity ofmaintenance, the termination ofuse and the mitigation of residual
neurobiologic sequelae). As anexample, under a separate
announcement (see above), NIDAhas solicited and continues to
solicit proposals using virtual realityto increase our understanding of
the neurobiology of addiction, (e.g.,drug cues, craving), comorbidity(e.g., post-traumatic stress
disorders) and pain (e.g.,distraction). Additional novel
approaches, devices and strategiesare now being sought to further our
understanding of the cognitiveneuroscience of drug abuse andaddiction, neuroplasticity and
repair, the neurobiology oftreatment (including training tools,
assessment and neurolobiologiccorrelates of treatment outcome),
neuroAIDS, and humanpain/analgesia. Techniques such
as hyperbaric oxygenation, used toincrease oxygen in blood in
experimental and treatmentprotocols, may improve drug-induced cognitive deficits.
Transcranial magnetic stimulation,utilized to modulate cortical
excitability, deep brain stimulation
to improve refractory comorbidconditions, and biofeedback controlof cortical function are otherexamples of untested possibilities
in the study of addiction. We arecasting a wide, interdisciplinary net
to encourage cutting-edge, state-of-the-art proposals. As with all
NIDA-funded research, theconceptual framework, design,methods, and analyses must be
adequately developed, well-
integrated, and appropriate to theaims of the project. The applicantmust acknowledge potential
problem areas and consideralternative approaches. Whereasthe proposal must employ novel
concepts, approaches or methodsthat are not mainstream to drug
abuse, the inclusion of establishedanalytic tools to determine the
efficacy of the approach isrequired. The aims must be originaland innovative and the proposal
should challenge existingparadigms or develop new
methodologies or technologies. Inaddition, the investigator must be
appropriately trained and wellsuited to carry out this work andthe work proposed must be
appropriate to the experience levelof the principal investigator and
team of other researchers (if any).
Ro Nemeth-Coslett, Ph.D.
(301) 402-1746
Email: [email protected]. Medications Research GrantsBranch (MRGB). The MRGB supports
investigations of the use of therapeuticagents (including vaccines and
monoclonal antibodies) for thetreatment of substance related
disorders, with the aim of assisting inreducing drug use, becoming drug free,
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prolonging abstinence, decreasingassociated psychosocial, medical or
legal problems, or surviving drugoverdose. In general, therapeuticagents are expected to be investigated
using a platform of appropriatepsychosocial interventions. The
program funds extramural grants in the
following areas:
Clinical trials to test the safety, find
the optimal dose, and/or obtainpreliminary efficacy data for newagents or new indications of
marketed medications. This phaseincludes interaction studies to test
the safety of the agent when used incombination with drugs of abuse.
Clinical trials to assess the efficacy
of new agents or marketed
medications for the treatment ofsubstance related disorders. Ingeneral, these types of trials use arandomized double blind placebocontrolled design.
Clinical studies of the efficacy of
medications for the treatment of thecomorbidity of substance related
disorders (e.g., alcohol and cocainedependence) or the comorbidity of
these disorders with other medicalor psychiatric conditions.
Clinical evaluation of the efficacy of
medications for the treatment ofsubstance related disorders in
specific groups of the population.For example, adolescents, the
elderly, women of childbearing age,pregnant and/or postpartum women,
as well as racial and ethnicminorities.
Evaluation of biological and/or
psychosocial factors that may affect
the outcome of thepharmacotherapy of substancerelated disorders.
Specific areas that may be of interest to
small businesses include, but are notlimited to:
1. Pharmacogenetics and SubstanceUse Disorders. The emergence of
new genetic techniques may allowthe use of genetic information to
improve the safety and efficacy oftreatments. The field ofpharmacogenetics focuses on the
genetic determinants of responseto medications and other in
humans and animals. The goal is
to discover novel single nucleotidepolymorphisms (SNPs) and testtheir relevance to the underlyinggenetic differences that determine
the safety and efficacy ofmedications for the treatment of
SUD. It includes the study of genesencoding drug metabolizing
enzymes, transporters, receptorsand other drug targets, polygenicdeterminants of drug disposition
and effects in humans, the role of
genes in the clinical response toand medical safety of medications,and application of genetic
information to disease preventionand to optimize treatments inhumans. It also includes novel
methods for phenotyping thediagnosis, safety and treatment
outcome of SUD. Ultimately, it isexpected that pharmacogenetics
research will help clinicians toindividualize the treatment of theirpatients based on their genetic
information. Research is needed tostudy the genetic factors that may
be associated with drug abusetreatment safety and outcome.
2. Medications Development for theTreatment of Drug Abuse inAdolescents. Drug abuse amongadolescents is a significant and
growing public health concern. It isknown that the pharmacokineticsand pharmacodynamics of some
medications are different in
adolescents. Therefore,adolescents may presentoverdoses, underdoses or lack of
efficacy, or different safety profileswhen administered medications atthe doses studied only in adults.
Unfortunately, little is known aboutthe safety and efficacy of
medications for the treatment ofdrug abusing adolescents because
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most of the drug abuse medicationresearch has focused on adults.
Research is needed to testmedications for the treatment ofnicotine and drug abuse in
adolescents.
3. Medications for the Treatment of
Pregnant and Post-Partum DrugAbusing Women and TheirChildren. Little is known about thesafety and efficacy of medications
for the treatment of substanceabusing pregnant women and theirchildren. There is a need for safe
and effective medications for thetreatment of nicotine and drug
abuse among pregnant and post-partum women and the effect of the
medications on their children.Research is also needed to study
the effects on the newborn of themedications taken by the motherand medications for treatment of
children born to substance abusingmothers who may present drug
withdrawal and other symptoms.
4. Medications for the Treatment ofComorbid Medical or MentalDisorders and Drug Abuse.Comorbid medical and psychiatricconditions are frequently foundamong substance abusing patients.
Co-occurring mental disorders,such as depression, post-traumatic
stress disorder, and anxietydisorder, and medical conditions
such as hepatitis C, AIDS relateddisorders, and pain, are commonamong substance abusing patients.
Unfortunately, there are presentlyno commonly prescribed safe and
effective medications for thetreatment of substance abusing
patients with other comorbidmedical and psychiatric conditions.
Research is needed to study thesafety and therapeutic profiles ofmedications for treatment of
substance abuse in patients withother comorbidities. There is also a
need to study the effects ofmedications for the treatment of
substance use disorders in patientstaking medications for other
comorbid conditions and thenecessary dose adjustments.
5. Development of Software and/orOther Tools for Data Collection andStatistical Analysis of Clinical TrialsTesting the Safety and Efficacy ofTherapeutic Agents for the
Treatment of Substance RelatedDisorders. Current data collectiontechniques often have questionablevalidity and reliability and statistical
data analysis pose particularchallenges. These problemsinclude lack of well defined
outcome measures or having alarge amount of missing data,
which may be due to intermittentmissing data points or early subject
drop out (attrition). To solve thosechallenges, investigators have
developed pragmatic methods toanalyze their data. For example,carry forward data from the last
timepoint, data replacement byregression, end point analysis by
regression, or worst case scenario,they all have important statistical
limitations. The purpose of thisinitiative is to stimulate research oninnovative data management tools
to improve data collection andanalysis of data from nicotine and
drug abuse clinical trials.
Ivan D. Montoya, M.D.
(301) 443-8639
Email: [email protected]. Immunotherapy for Addiction
Treatment. The MRGB supportsresearch on the advanced stagedevelopment of monoclonal
antibodies and vaccines for thetreatment of drug and nicotineaddiction and/or overdose.
Monoclonal antibodies have beenreported as possible treatment
agents through passiveimmunization for PCP,
methamphetamine, MDMA, andcocaine overdose and may alsoserve to minimize abuse and
prevent relapse. New vaccines arebeing developed as therapies for
drug or nicotine cessation andrelapse prevention. New
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technologies, such as theproduction of antibodies in plants,
are emerging as cost-effective andefficient ways for the large scalemanufacture of immunotherapy
agents, represent another facet ofthis area for development.
Jamie Biswas, Ph.D.(301) 443-8096
Email:[email protected]. Development of GHB Detection
Kits and Antidotes to Treat GHBPoisoning. A DAWN report statesthat there were over 3000emergency room visits connected
to GHB poisoning in the UnitedStates in 2001. GHB poisoningresults in respiratory depression
and coma, and can be fatal.Clinical interventions are needed to
facilitate recovery from intoxicationand/or poisoning from gamma-
hydroxy butyric acid (GHB). Thereis also a need for the developmentof diagnostic kits for the rapid
detection of GHB, gamma-butyrolactone (GBL), and 1,4-
butane-diol (BD) in body fluids(plasma, saliva, urine). The method
of detection should be fairly rapidand specific, and could be eitherqualitative or quantitative.
Detection kits are needed to assistemergency room doctors in the
rapid diagnosis of GHB poisoning,which is very difficult and critical for
the selection of a proper treatmentstrategy. The availability of such
kits would aid in the reduction ofmortality and treatment costs.8.Development of Neurotechnologyfor the Treatment of DrugDependence. MRGB is interestedin clinical research evaluating theefficacy of emerging
neurotechnological diagnostic andtherapeutic modalities for treatingdrug dependence and addiction,
with particular emphasis onpsychostimulants, opiates, nicotine
and cannabinoids. An example ofsuch a therapy would be
Transcranial Magnetic Stimulation(TMS) of the brain. TMS is a
noninvasive technique currentlyused as a diagnostic and
therapeutic tool in neurology andpsychiatry. It has been reported toreduce symptoms of depression,
PTSD, OCD, epilepsy, migraine,Tourettes syndrome, Parkinsons
disease, and hallucinations in
schizophrenic patients. Thetherapeutic uniqueness of thistechnique lies in the relativeneuroanatomical specificity of its
effects, in contrast to generalizedeffects of pharmacotherapies. TMS
may be used to rapidly, eitherlaterally or focally, alter cortical
brain activity, which might behelpful in the treatment of drugdependence. Repetitive TMS may
alleviate drug craving by the brief
deactivation of certain brainregions. It may also improve moodand enhance cognition, thus
facilitating abstinence from drugs ofabuse and increasing effectivenessof cognitive therapies.
9. Research and Development ofPsychobiological Markers ofResilience or Refractoriness ofDrug Dependence as a Tool forOptimization of Treatment.Difficulties in finding rapid and
effective therapies for drug
dependence, especiallydependence on psychostimulants,appear to result, in part, from theheterogeneity of drug addicts
entering treatment programs ortrials. This heterogeneity may
ensue from differentpsychobiological and genetic
determinants, including psychiatriccomorbidities, which contribute tothe development and persistence
of drug dependence. Studies and
clinical observations show thatsome addicts recover relativelyeasily after standard treatments for
stimulant dependence, while othersrelapse early or drop out of thetreatment. Identifying
psychobiological markersdistinguishing different groups of
addicts may permit selection ofoptimal treatment strategies for
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these groups, which may or maynot include selective
pharmacotherapy in addition tostandard psychotherapeuticmodalities. Research is needed to
identify potential biological andpsychological markers, which
correlate with resiliency or
refractoriness of drug/stimulantaddicts. Identification of suchmarkers may guide development ofnovel treatments for drug
dependence. There is a need foranalytic kits for simultaneous
detection of several hormonessuch as PS, DHEAS, THP,
THDOC, cortisol and testosteronein body fluids, optimally in saliva.Detection kits for steroid hormones
may also have broader utility as
aids for diagnosis of otherpsychiatric disorders, such asdepression and PTSD.
Maria D. Majewska, Ph.D.(301) 443-9807
Email: [email protected]
Division of Neuroscience and BehavioralResearch (DNBR)
DNBRs basic neuroscience and
behavioral research focuses on
understanding the mechanisms,characteristics, and processes of drug
abuse. Basic behavioral, cognitive,neurobiological, cellular, molecular,
chemical, and genetics research aims at
characterizing and understanding drugseeking, compulsive behavior, and
addictive processes. These research
areas necessarily include studies of
normal processes.Using both animal and human studies,
basic behavioral research focuses onbehavioral and cognitive processes thatmay or do lead to drug initiation, and the
behavioral and cognitive consequences
of drug abuse. Neurobiology researchfocuses on the neural mechanisms and
substrates underlying behavioral and
cognitive processes and vulnerability
factors associated with drug abuse,
addiction, sensitization, tolerance, andrelapse.
DNBR supports basic chemistry and
pharmacological studies focusing onstructure/activity relationships,
definition, and characterization of
systems involved in drug actions,
chemical synthesis of new ligands,pharmacokinetics, analytical methods,
understanding basic mechanisms of drug
action and drug testing.Computational and theoretical modeling
of biological systems and behavioral
processes, biomedical computing and/orinformation science and technology
development is supported by DNBR.A. Research Related to the Design of New
Therapeutic Approaches.Development of new therapeutic
approaches based on the application ofnanoscale particle formulations for
drugs that are either poorly water-soluble or otherwise unstable under
physiological conditions, anddevelopment of methods for usingnanoscale formulations for targeting
specific brain sites or to control drugdelivery over extended periods of time.
Thomas G. Aigner, Ph.D.
(301) 443-6975Email: [email protected]. Virtual Reality for Treatment of Pain.
Recent findings (Hoffman et al., 2000,Pain, 85, 305-309) have suggested that
Virtual Reality (VR) exposure canreduce reported pain during wound
care. Grant proposals are sought toexamine the utility of VR technologiesin the treatment of various types of
pain. Development of treatments forboth acute and chronic pain are sought.
These treatments can be based in
clinical settings or the patients homes.Phase I testing should establish thefeasibility of the use of this technologyin the particular population to be tested.
Phase I should also produce data thatdemonstrates that this methodology is
effective for the particular type of painbeing treated. Phase II should involve
larger-scale testing (e.g., more subjects
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and treatment trials) examining varioustreatment parameters (e.g., timing of
treatment, types of VR environments).The focus of Phase II testing should bethe refinement of this treatment for use
in pain patients.
C. Virtual Reality for the Treatment of
Drug Abuse. Recent findings (Hoffmanet al., 2000, Pain, 85, 305-309) have
suggested that Virtual Reality (VR) canbe a useful clinical tool. In this
particular study, VR exposure wasused to allow patients to selectively notattend to an otherwise painful
procedure. Drug abuse, like pain, is aproblem that is strongly impacted by
stimuli in the abusers environment andpsychological factors. Thus, it is
reasonable to assume that VR may beuseful in allowing individuals to ignore
drugs cravings, withdrawal symptomsor environmental cues that promotedrug abuse. Grant proposals are
sought to examine the utility of VRtechnologies in the treatment of various
types of drug abuse. These treatmentscan be based in clinical settings or the
patients homes. These treatments canbe developed to address drugwithdrawal, drug craving or on-going
drug related behaviors. Thedevelopment of VR technologies to
address abuse of all types of drugs
(e.g., cocaine, marijuana, nicotine,alcohol, inhalants) are sought. Phase Itesting should establish the feasibility ofthe use of this technology for the
particular drug problem addressed(e.g., cocaine craving, opioid
withdrawal) and should also producedata that demonstrates that this
methodology is effective for theparticular drug problem. Phase IIshould involve larger-scale testing
(e.g., more subjects and treatment
trials) examining various treatmentparameters (e.g., timing of treatment,types of VR environments). The focus
of Phase II testing should be therefinement of this treatment for use inthe treatment of drug abusers.
David Thomas, Ph.D.
301-443-6975
Email: [email protected]
D. Chemical Libraries for DrugDevelopment. The development andbiological screening of lead compoundsand their combinatorial libraries for usein the area of drug abuse treatment
research are encouraged, such asgeneration of new ligands having
opiate receptor selectivity, or ligands
with NMDA or serotonergicagonist/antagonist activity and/orrelated. These are designed as leadcompounds either for drug design or as
tools to elucidate mechanisms of actionof drug abuse.
Hari H. Singh, Ph.D.(301) 443-6300
Email: [email protected]. Genetic Studies. The National Institute
on Drug Abuse is interested in SBIRproposals that would greatly facilitate
the identification of genetic loci thatconfer vulnerability to substance abuse
and addiction. Areas of interest includebut are not limited to:
1. Collection and genotyping ofhuman pedigrees and sib-pairs for
vulnerability or resistance to drugabuse.
2. Isolation and identification ofmutant strains in genetic model
systems such as Zebrafish,Drosophila, C. elegans, mice, andrats that are more vulnerable or
resistant to drugs of abuse.
3. Design, development, and
marketing of behavioralapparatuses to conduct rapid
behavioral throughput screens foridentifying genetic vulnerability to
addiction in genetic modelsystems.
4. Development of transgenic modelsfor drug abuse using bacterial
artificial or yeast artificialchromosomes.
5. Development of software anddatabases for candidate genes fordrug abuse.
6. Identification and mapping of
functional polymorphisms ofcandidate genes for drug abuse.
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7. Placement of candidate genes fordrug abuse on biochips.
8. Marker-assisted breeding ofcongenic mouse and rat strains for
mapping quantitative trait lociassociated with addiction and drugabuse.
9. Vectors for gene transfer intoneurons.
Jonathan Pollock, Ph.D.
(301) 443-6300
Email:[email protected]. Drug Testing Development.
Development of new, more refined or
more practical drug testingmethodologies. Studies may focus, butare not limited to the following topics:
drug testing methods; drug extractionprocedures; methods to control for
possible environmental contaminationfactors; and reference materials.
Methodologies with special applicationto the workplace, the emergency room,the transportation environment, or other
specific settings are welcome.Methodologies with an emphasis upon
circumstances for testing such as post-accident testing or readiness for work
testing are also encouraged.
Beth Babecki, M.A.
(301) 443-1887
Email: [email protected]. Effects of Drugs at the Cellular Level.
Development of new imaging
techniques, reagents and relatedhardware and software for dynamic
investigations of the effects of drugs ofabuse on cellular activities andcommunications. For example, these
techniques might include, but are notlimited to, development and utilization
of reagents for magnetic resonancemicroscopy and other MRI methods;
development of methodologiesapplying functional MRI to drug abusestudies; the use of dyes, intrinsic
signals, and other optical indicators forstudying signal transduction
mechanisms, the regulatory control ofprotein entities (such as
phosphorylation), and neuronalexcitatory and inhibitory pathways.
Areas of interest may include, but arenot limited to:
1. Studies using molecular biologicaltechniques to scale-up protein
production for investigations aimedat enhancing understanding of thestructure, function and regulation of
molecular entities involved in thecellular mechanisms through which
abused drugs act.
2. Validated in vitro test systems can
reduce the use of animals inscreening new compounds that
may be of potential benefit intreating drug abuse. Test systems
are needed to evaluate activity atreceptors or other sites of action,explore mechanism(s) of action,
and assess potential toxicity.
3. With the recent success inmolecular cloning of various drugabuse relevant receptors,
enzymes, and other proteins,researchers will elucidate the
molecular mechanism of action ofthese drugs. Studies to generate
strains of transgenic animalscarrying a gene of interest aresolicited. Of special interest are
knockout and tissue-specificknockout animals. These animals
can be used to identify gene
function, and to study thepharmacological, physiological,and behavioral role of a singlegene.
Jonathan Pollock, Ph.D.(301) 443-6300
Email:[email protected]. Toxicity Studies
1. Studies on abused drugs and their
metabolites to developmethodologies that may be
potentially useful in addressingmedical emergencies. Such studiesmight include investigations
involving development ofpharmacokinetic models,
methodologies, and data.
2. Concern remains about the
potential acute and chronicneurotoxicity of drugs of abuse.
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Information is needed about thepossible neurotoxicity of
pharmacotherapeutic agents withpotential for treating drug abuse.Improved methods are needed for
identifying, assessing, andquantifying the nature and extent of
neurotoxicity. Such studies might
include the development orapplication of quantitativechemical, physiological, orbehavioral measurements relating
to nervous system injury ormethods for quantitative analysis of
damage.
I. Predisposition to CardiovascularComplications Associated with AbusedSubstance(s). Development ofexperimental animal models to assessa genetic predisposition or increased
sensitivity to cardiac and vascularcomplications associated with druguse. Such studies might include, but
are not limited to, investigationsinvolved with biochemical, physiological
and pathological indices ofcardiovascular system function.
Pushpa V. Thadani, Ph.D.(301) 443-6300
Email: [email protected]. Opioid Peptides. Research and
development directed at the medicinal
chemistry and molecular pharmacologyof opioid peptides, especially inmethods development. Areas ofinterest include but are not limited to:
1. Development of innovative
methodologies for the synthesis ofopioid peptides to be madeavailable to researchers.
Syntheses proposed should belimited to single analogs.
2. Methods to identify new ligands foropioid receptors and the design of
new opioid peptide analogs withtherapeutic potential.
3. Development of analyticalmethodologies for the quantitation
of synthetic and endogenous opioidpeptides, peptide precursors, and
processing enzymes. Theinnovation may be limited to a part
of the method, such asdevelopment of a special detector
or a sample cell. Methods mightinclude antibody development anddevelopment of innovative
immunoassays.
K. Dopamine and Serotonin Receptor
Ligands. Both dopamine and serotoninreceptors exhibit multiple subtypes.
Applications are solicited usingchemical combinatorial library
techniques to develop ligands having ahigh degree of selectivity to thesereceptor subtypes, which can be useful
both as pharmacological tools and leadcompounds in medicinal chemistry/drug
development.
Rao Rapaka, Ph.D.
(301) 443-6300
Email: [email protected]. Systems Biology. The NationalInstitute on Drug Abuse is interested in
SBIR proposals that would facilitateglobal analysis of biological systems
relevant to drug abuse. Technologiesand resources developed should be
applicable and relevant to drug abuseresearch. Areas of interest include, butare not limited to:
1. Improved technology for analysis of
membrane proteomes for theidentification of targets andvalidation of leads.
2. Development of technology or newstrategies that will improve
dynamic range to allow theanalysis of a broader spectrum of
the proteome of neural cells.
3. Single cell analysis and the
development of model systems forproteomic analysis of neuronal
function and drug effects.
4. Development of real-time
proteomics technology for theanalysis of processes such as
cellular responses to drugexposure.
5. High throughput, high resolution3-dimensional in situ proteome
profiling such as optical projectiontomography, improved methods for
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high throughput sectioning ofneural tissue and the development
of tools for identifying and mappingprotein expression, localization andmovement relevant to addiction
and other medical consequencesof drug abuse.
6. High throughput, functional,molecular interaction screening
methods for proteins implicated indrug abuse.
7. Strategies to characterize post-translational modifications related
to addiction and drug effects.
8. Development of proteomic tools for
identifying biomarkers to tracktherapeutic efficacy, to monitor
effects of drug interactions, and toadvance biological understanding
of relationships between drug useand infectious disease, andtherapies for HIV, hepatitis C and
other diseases.
9. Development of computational
tools such as knowledge bases,information systems and
computational models for proteindata related to addiction and other
medical consequences ofsubstance abuse. Tools thatenable the integration of
proteomics, genomics,transcriptomics, metabolomics and
other data into applications leadingto systems understanding of drug
effects upon biological systems.
10. Technologies to identify
parameters of molecular, cellular,or physiological systems important
in addiction, and the properties ofthe system, such as redundancyand robustness.
11. New approaches for characterizing
cell phenotypes and mapping thosephenotypes.
Karen Skinner, Ph.D.(301) 443-6300
Email: [email protected] Colvis, Ph.D.(301) 443-6300
Email: [email protected]. Research Resources. The National
Institute on Drug Abuse is interested inSBIR proposals that would generate
the following resources for drug abuseresearch:
1. Resources for the application of
genetic engineering to dynamicallymonitor neuronal function.
2. C57BL6 Mouse embryonic stem
cells and spermatogonial stemcells.
3. Turnkey technology for proteomicssuch as the development of protein
and peptide chips to study drugeffects on neuronal mechanisms.
4. Antibodies, aptamers, ligands, etc.relevant to drug abuse research.
Jonathan Pollock, Ph.D.(301) 443-6300
Email:[email protected]. Development of Innovative Pulmonary
Nicotine Delivery Systems. NIDA isseeking SBIR grant applications for
development of devices that achievethe pulmonary delivery of nicotine inhuman subjects. A major effort in
smoking cessation centers on nicotinereplacement. Pulmonary delivery of
nicotine should permit more reliable
replication of the delivery that occursduring the inhalation of tobacco smoke.Thus, such devices would provevaluable as resources in support of
research studying the efficacy of rapidnicotine replacement, and as potential
future aids in smoking cessation. Thedevices should be small, portable, and
deliver a smoking-dose of nicotine ina reliable manner.
Allison Chausmer, Ph.D.(301) 402-5088
Email: [email protected]. Development of Innovative SyntheticProbes, Drug Dosage Forms, and/orDrug Metabolites For Drug AbuseResearch. Proposals are solicited forthe synthesis of new chemicalcompounds, drug metabolites,
peptidomimetics, and/or developmentof drug dosage forms for studying the
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mechanism of action of drugs of abuseand drug addiction.
Specifically proposals are encouragedin the following areas:
1. Synthesis of chemical probes, drugmetabolites, peptidomimetics,
and/or development of drug
dosage forms that are needed bydrug abuse research investigators,and they are not commerciallyavailable, and/or available with
great difficulty.
2. Alternate synthetic methods for
existing chemical probes thatimprove the yield and produce
these chemicals at lower costs ascompared to commercially
available substances.
3. Development of alternate drugdosage forms of existingdrugs/drug products for enhancing
their efficacy.
Hari H. Singh, Ph.D.
Phone: (301) 435-1310
Email: [email protected]. Development of Analytical Techniques.
The development of new analytical
methods for measuring drugs of abuseand their metabolites in biological
matrices, such as urine, blood, saliva,sweat, hair, breast milk, brain tissue,and meconium is encouraged. The new
methods should be efficient, sensitive,convenient, and cost effective.
Modifications and improvements inexisting analytical techniques are also
encouraged particularly thoseimproving sensitivity and selectivity.
Hari H. Singh, Ph.D.Phone: (301) 435-1310
Email: [email protected]
Office of Science Policy andCommunications (OSPC)
SCIENCE POLICY BRANCH (SPB)
Science Education. In order to improve
science education in the area of drugabuse research (e.g., disciplines such as
neuroscience, psychology,
epidemiology), efforts are needed to
develop innovative methods forimproving knowledge of and generating
interest in science among school
children, the general public, and healthcare providers, including providers
involved in drug abuse treatment. These
might include but are not limited to:A. Development of methodologies to
present drug abuse and scienceinformation to particular groups, such
as kindergarten and elementary schoolstudents, African Americans,Hispanics, persons with disabilities and
health care providers.
B. Development of methodology to
transfer new knowledge and directionsof scientific growth to teachers,
curriculum developers and health care
providers.
C. Development of computer-basedlearning systems that allow students to
experience the scientific process.
D. Development of specific materials,
activities, or programs that promotescience education related to drug
abuse, such as exhibits, curriculummaterials, coloring books, videos,teacher education workshops,
partnership programs with scientistsand educators, or workshops for health
care providers.
E. Development of specific materials,
activities or programs that promote theteaching of scientific and research
ethics to middle and high schoolstudents.
Cathrine A. Sasek, Ph.D.(301) 443-6071
Email: [email protected]
Division of Epidemiology, Services and
Prevention Research (DESPR)
A. Prevention Research Branch (PRB).The Prevention Research Branch(PRB) supports a program of research
in drug abuse and drug related HIVprevention to (1) examine the efficacy
and effectiveness of new andinnovative theory-based prevention
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approaches for drug abuse, drug-related HIV/AIDS and other associated
health risks, (2) determine thecognitive, social, emotional, biologicaland behavioral processes that account
for effectiveness of approaches, (3)clarify factors related to the effective
and efficient provision of prevention
services, and (4) develop and testmethodologies appropriate for studyingthese complex aspects of preventionscience.
Prevention Research. Rigorousscientific prevention research is
encouraged to study novel approachesto substance abuse prevention for use
at multiple levels of the socialenvironment including: the family,
schools, peer groups, community andfaith-based organizations, the
workplace, health care systems, etc.The purpose of this research is todetermine the efficacy and
effectiveness of novel programmaterials, training strategies, and
technologies developed to prevent theonset and progression of drug abuse
and drug-related HIV/AIDS infection.Materials and technologies may targeta single risk-level or may take a
comprehensive approachencompassing audiences at the
universal, selective, and/or indicated
levels. Universal interventions targetthe general population; selective targetsubgroups of the population withdefined risk factors for substance
abuse; indicated interventions targetindividuals who have detectable signs
or symptoms foreshadowing drugabuse and addiction, but who have not
met diagnostic criteria. NIDAencourages the development andtesting of innovative prevention
intervention technologies that are
sensitive and relevant to cultural andgender differences.
1. Laboratory studies of the
underlying mechanisms and effectsof various prevention approaches
such as persuasive communication(e.g., mass media and print media)
as they are affected by and affect
drug related cognition, emotion,motivation and behaviors.
2. Decomposition of preventionprograms to understand
components that account forprogram effectiveness.
3. Research on design features of
prevention curricula, materials, andapproaches that result in positiveoutcomes.
4. Training modules for programimplementers of research basedsubstance abuse prevention
programming strategies.
5. Prevention interventiondissemination technologies andmechanisms that integrate
research with practice; specifically
the transfer of drug abuseprevention information to decision-makers, funders, and practitioners.
6. Prevention services research onthe organization, financing,
management, delivery, andutilization of drug abuse prevention
programs.
7. Strategies for the integration of
proven prevention approaches intoexisting service delivery systems.
8. Studies that develop and assess
reliability and validity ofdevelopmentally appropriate self-report, physiological, andbiochemical measures for use in
prevention trials in a variety ofsettings and a variety of audiences.
9. Development of community needsassessment tools and services.
10. Drug abuse preventionmethodological research on
promising data collection, data
storage, data dissemination, andreporting techniques.
Larry A. Seitz, Ph.D.
(301) 402-1725
Email: [email protected]. Epidemiology Research Branch
(ERB). The ERB supports a research
program on drug abuse epidemiologythat includes (1) studies of trends and
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patterns of drug abuse and relatedconditions such as HIV/AIDS in the
general population and amongsubpopulations, (2) studies of causalmechanisms leading to onset,
escalation, maintenance, and cessationof drug abuse across stages of human
development, (3) studies of person
environment interactions, (4) studies ofbehavioral and social consequences ofdrug abuse, (5) bio-epidemiologicstudies including genetic epidemiology
studies, (6) methodological studies toimprove the design of epidemiologic
studies and to develop innovativestatistical approaches, including
modeling techniques.
1. Improvement of Reliability andValidity of Reporting of SensitiveData. The reliability and validity of
self-report of drug use and relatedbehaviors (e.g., HIV risk behavior)is a matter of great concern. Use of
new technologies for real time datacollection in ecological settings is
of great interest because thesetechnologies enable collection of
drug consumption data in context.Studies to improve methodologiesbased on variations of standard
survey protocols or computer-assisted self-interview (CASI) and
personal interview (CAPI) are also
encouraged.
2. Instrument Development. Easy-to-use assessment instruments are
needed to enhance epidemiologyresearch. Areas of interest includebut are not limited to:
a. Community Assessment. Thedevelopment of communitydiagnostic instruments forpsychometrically sound
assessment of community
characteristics is essential toimprove our understanding ofhow community factors affect
drug abuse and ensuingbehavioral and socialconsequences. Standardized
assessments of communitycharacteristics are needed to
better understand the fullimpact of drug use and to
develop targeted interventionsto specific community needs.
b. Assessment of PsychiatricComorbidity in CommunitySettings. Easy to use, reliable,and valid instruments areneeded to assess psychiatric
comorbidity in differentpopulations of drug abusers,
including adolescents andthose in community drug abuse
treatment settings.
c. Assessment Instruments toMeasure CNS FunctionRelated to Drug Abuse. Thedevelopment of age-appropriate assessmentinstruments to measure
behavioral and cognitive
function over the course ofdevelopment will contribute toour understanding of
vulnerability to drug abuse andfunctional impairment due todrug use.
Lynda Erinoff, Ph.D.
(301) 443- 6720
Email: [email protected]. Services Research Branch (SRB).
The SRB supports a program of
research on the effectiveness of drugabuse treatment with a focus on thequality, cost, access to, and cost-
effectiveness of care for drug abusedependence disorders. Primary
research foci include: (a) theeffectiveness and cost-benefits and
cost-effectiveness of drug abusetreatment, (b) factors affectingtreatment access, utilization, and health
and behavioral outcomes for definedpopulations, (c) the effects of
organization, financing, andmanagement of services on treatment
outcomes, (d) drug abuse servicedelivery systems and models, such ascontinuity of care, stages of change, or
service linkage and integration models,and (e) drug abuse treatment services
for HIV seropositive patients and forthose at risk of infection.
1. Drug Abuse Treatment EconomicResearch. This initiative will
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support research to design anddevelop data systems for financial
management and economicanalysis of treatment programs andlarger systems in new healthcare
settings and managed carenetworks. Managerial decision-
making requires the
implementation of sophisticateddata systems to facilitate routinebudgeting processes, allocation ofresources, performance
measurement, and pricingdecisions. The focus is on the
needs of managers within theorganization and managers outside
of the organization. Data systemdevelopment must be based onstandard cost behavior and profit
analysis. Data systems must be
designed with correct costconcepts (accounting andeconomic) in order to permit cost
and pricing decisions to bedeveloped for new treatmenttechnologies and management of
on going systems. In researchsettings, such an initiative is vital
for the assessment of newtechnologies developed for transfer
to practice.
William S. Cartwright, Ph.D.
(301) 443-4060
Email: [email protected]. Personnel Selection Technology
Research for Drug AbuseTreatment Clinics. NIDA would beinterested in supporting small
innovative research that developsand validates generic selectionsystems that could be adopted and
tailored for use by drug abusetreatment clinics. Like many small
businesses, drug abuse treatmentclinics have problems attracting
and retaining qualified personnel.Also like many small businesses,treatment clinics have limited
resources to apply to the recruitingand hiring of new and replacement
personnel. Though reliable dataare lacking, a great many clinic
directors complain of high annualstaff turnover rates. This has been
attributed anecdotally to poorquality of work life, low wages, low
skill levels, incompatibilities withthe clinics treatment philosophy,and the high stress of working with
drug abusers. Research has shownthat the application of standardized
selection methods designed to
maximize person-job fit can cost-effectively reduce staff turnover.Systematic methods such asbackground inventories, protocol-
driven interviews, aptitude tests,and credit checks have
demonstrated validity for improvingperson-job fit. Examples of
possible projects might includedevelopment of easy-to-understandguidance about legal
considerations in hiring practices,
software that transform job taskanalysis into selection criteria,interview protocols to standardize
applicant screening, tolls to helpimprove recruitment, and/or self-paced training for hiring officials or
interview panels to improvescreening reliability.
3. Customer Retention Technology.Premature disengagement from
drug abuse treatment participationis a common problem and ranges
from approximately 30 to 60%
based upon the clinic and modalitystudied. Past research has veryfrequently attributed dropping outof treatment to participant
characteristics (e.g., motivation,addiction severity, comorbidity)
and/or environmental factors (e.g.,social pressures, unemployment,
homelessness). Seldom has thedropout problem been studied inthe context of customer
satisfaction. That is, there is little
research looking at the causes ofdropping out of treatmentatt
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