MEDICAL MARIJUANA USE & REDUCTION OF POST-TRAUMATIC STRESS DISORDER SYMPTOMS

Team :  Jennifer Youngs & Wilson Ospina

Faculty Mentor: Dr. Halcyon St. Hill, Professor

IHS 4504 Research Methods CRN: 80374 Florida Gulf Coast University

Date:  November 10, 2014

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ABSTRACT

The causes, symptoms, treatments, and effects of Post-traumatic Stress Disorder can

be extremely costly. It has a high prevalence rate and is a major health concern. Medical

marijuana has valuable health benefits, and is already being utilized legally in many states, as

well as illegally by suffering patients, who get it from the black market. All evidence supports

and elicits the need for further research to determine whether Medical marijuana should be

utilized as a legal form of treatment for patients suffering from PTSD, and other chronic

conditions. Though it is demonstrated that medical marijuana is effective at reducing

symptoms of PTSD, more studies need to be performed in order to add validity and empirical

evidence to support these claims.

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INTRODUCTION: LITERATURE REVIEW

After many years of categorization as a Schedule 1 narcotic by the Drug Enforcement Administration (DEA) of the United States, within the last two decades, much attention has been placed on the therapeutic benefits of medical marijuana (Title 21 United States Code (USC) Controlled Substances Act, n.d.)

As of 2014, twenty-three states have amended State laws allowing use of medical marijuana for treatment of Post Traumatic Stress Disorder (PTSD), along with several other debilitating medical conditions (State Marijuana Laws Map, n.d.)

FDA approved two pharmacological agents to treat PTSD, include the (Setraline or Paroxetine); Both drugs are known as selective serotonin reuptake inhibitors (SSRIs) and

only have a 50 % success rate at reducing symptoms (Cukor, Olden, Lee, & Difede, 2010).

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INTRODUCTION: LITERATURE REVIEW Medical marijuana has been shown to have anti-epileptic properties , sedative

type effects, as well as anxyiolytic and anti-psychotic effects (Zuardi, 2008).

Medical marijuana use has been shown to remove aversion memories, which are the root causes of PTSD(Greer, Grob, & Halberstadt, 2014).

Post-traumatic Stress Disorder occurs after an individual has suffered from a traumatic or petrifying experience such as:

1)sexual assault 4)terrorist attacks 7)unnerving experiences 2)physical abuse and neglect 5)combat warfare 3)environmental disasters 6) traumatic accidents

(U.S. Department of Veterans Affairs, 2013).

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INTRODUCTION: LITERATURE REVIEW

Symptoms that are associated with PTSD vary but generally include:

1) anger and irritability 2) anxiety 3) fear and panic 4) feeling of hopelessness 5) depression and sadness 6) Feelings of blame, remorse and guilt 7) changes in demeanor 8) changes in conduct 9) loss of sense of self-identity

(U.S. Department of Veterans Affairs, 2013).

Severity of PTSD is not only affected by the symptom type and cause, but also by the duration of such symptoms (Freedy & Brock, 2010).

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TOPIC, PROBLEM, AND PURPOSE

Topic: Medical marijuana as a treatment for reducing symptoms in patients

diagnosed with Post-traumatic Stress Disorder.

Problem: There is no known cure for PTSD, therefore, it is not known whether use of

marijuana will have positive effects on PTSD related symptoms. Although various states have currently legalized the use of medical

marijuana, federally it is still considered an illegal Schedule I narcotic in accordance with the Controlled Substances Act (CSA) of 1970 (Title 21 United States Code (USC) Controlled Substances Act, n.d.)

Purpose: To indicate that there is a positive correlation between using cannabinoids

and reducing symptoms of PTSD.6

RESEARCH QUESTION AND THEORETICAL POPULATION

Question: What are the effects of Medical marijuana use on symptoms

associated with PTSD, for men and women age 18 to 55, who have been diagnosed with PTSD within the past six months and have not yet begun treatment?

Hypothesis: Medical marijuana use will reduce symptoms associated with

PTSD.

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METHODS: RESEARCH DESIGN This will be a true experimental study, and will include

Two group, pretest-posttest randomized experiment Notational Form:

R = Random assignment X = Treatment program O1 = Baseline Assessment scores O2= Treatment Impact Assessment scores O3=Treatment Impact Assessment scores O4= Treatment Impact Assessment scores

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R O1 X O2 X2 03 X3 04R O1 02 03 04

METHODS: STEPS Participants will be pre-screened to meet the inclusion-

exclusion criteria .

Participants will be evaluated for current substance abuse using a serum drug screening method.

Double-blind, random assignment of patients into control, and experimental groups to eliminate bias.

Control group will receive a three month supply of 25mg placebo treatment to be taken orally three times daily.

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METHODS: STEPS

Experimental group will receive a three month supply of 25mg capsules of concentrated medical marijuana to be taken orally three times daily.

This study is designed to last for one year, with quarterly evaluations/observations of symptoms.

At each quarterly evaluations serum drug screens will be performed to help control extraneous variables.

The study will conclude with a final post-test evaluation.

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METHODS: RATIONAL AND INTERNAL VALIDITY

Rational for Design: We used Two group, pretest-posttest randomized double blind

experimental design because this is a true experiment and needed a strong type of design to eliminate all threats to validity and to further provide sufficient structure and accuracy of results.

Internal Validity:

Will be fair because quarterly drug screening methods will be used to help control some extraneous variables.

Other extraneous factors may be more difficult to control because this study will not be conducted in a laboratory.

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SAMPLE:THEORETICAL POPULATION & SAMPLING FRAME

Theoretical Population: Males and females ages 18 to 55, diagnosed with Post

Traumatic Stress Disorder according to the guidelines of Diagnostic and Statistical Manual of Mental Disorders, 5th edition.

Sampling Frame Subjects will be recruited by requesting local veteran’s

centers, physician offices, and mental health clinics to refer interested suitable patients, and by advertising in local media (t.v, radio, social internet media, and local newspapers).

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SAMPLE: STUDY POPULATION Study Populations

Males and females, between the ages of 18 to 55, diagnosed with Post Traumatic Stress Disorder within the last six months, according to the guidelines of Diagnostic and Statistical Manual of Mental Disorders, 5th edition, in the following states:

1) California 4) Oregon 2)Colorado 5)New Jersey 3)Illinois 6)New York

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NATIONAL DISTRIBUTION OF STUDY

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HUMAN RIGHTS ISSUES

Institutional Review Board (IRB) approval will be obtained prior to beginning the study.

All Participants will be provided full disclosure about the study including all requirements set by the IRB to ensure confidentiality, and privacy.

All participants will be given the opportunity to ask questions prior to signing the required informed consent documents.

All participants will be provided contact information, and will be given the opportunity to withdraw at any time.

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SAMPLING METHOD

Purposive, non-probability sampling Sampling will be performed with the purpose of finding

only patients diagnosed with PTSD within the past six months.

This method was chosen because sampling for proportionality is not a concern since it only applies to those diagnosed with PTSD within the last six months who have not yet begun treatment.

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SAMPLE: INCLUSION CRITERIA Participants must have been diagnosed with PTSD according to the

guidelines of Diagnostic and Statistical Manual of Mental Disorders, 5th edition, by a licensed physician.

Males and females ages 18 to 55 who have been diagnosed with PTSD within the past six months who have not yet begun treatment.

Participants must be pre-screened to verify no marijuana or illegal substance usage in the past 30 days.

Must be willing to submit to a health screening prior to commencement of study.

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SAMPLE: EXCLUSION CRITERIA

Participants that have any illnesses or other diseases that may interfere with the study.

Participants that take any prescribed or self prescribed medications.

Participants found to have failed the serum drug tests during the quarterly evaluations.

Participants that do not attend and complete follow-up evaluations.

Those that are unable to sign the informed consent document.18

ANALYSIS OF SAMPLING

The projected sample size is 200 individuals, composed of 100 male and 100 female participants who satisfy the inclusion and exclusion criterion.

50 males and 50 females will be randomly assigned to the placebo control group, while the other 50 males and 50 females will be assigned to the experimental group. This study will be replicated in each state previously listed under the

population frame.

The sample size will be of sufficient size for the study because: Variables include a placebo control group, experimental non-control group,

so there should be sufficient information from this sample size to analyze these limited variables and it will be representative of the population.

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ANALYSIS OF SAMPLING The sample size includes proportional samples of men and women

from various states nationwide to ensure accuracy.

Bias will be controlled with randomization, and by utilizing the double blind method.

External validity will be good because the samples will be representative of

different geographic locations throughout the nation, which will allow finding to be generalized to populations beyond the actual study group.

bias will be eliminated by the design type.

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GROUP ASSIGNMENT Random Group Assignment:

200 participants will be recruited from each state in which the study is being conducted; 100 males and 100 females.

From the sample groups, 50 males and 50 females will be randomly assigned to the placebo control group, while the remaining 50 males and 50 females will be randomly assigned to the experimental control group.

Double blind:The participants will be blind as to which group they belong to (the

control, or the experimental).The researchers will not know which groups in which the participants

belong.21

TREATMENT

Treatment: Medical Marijuana Program

Control group will receive a three month supply of 25 mg placebo treatment to be taken orally three times daily for one year.

Experimental group will receive a three month supply of 25mg capsules of concentrated medical marijuana to be taken orally three times daily.

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DATA COLLECTION:

Instruments:Clinician-Administered PTSD Scale (CAPS - 5)Post Traumatic Stress Disorder Symptoms Scale Interviews

(PSS-I). (See handouts for example)Serum drug tests

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DATA COLLECTED: CAPS-5 SCORES The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-

item structured interview that can be used to: Make current (past month) diagnosis of PTSD Make lifetime diagnosis of PTSD Assess PTSD symptoms over the past week

The CAPS was designed to be administered by clinicians and clinical researchers who have a working knowledge of PTSD, but can also be administered by appropriately trained paraprofessionals. The full interview takes 45-60 minutes to administer (PTSD: National Center for PTSD, n.d.)

Inter-rater Reliability is high

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DATA COLLECTED: PSS-I SCORES The PTSD Symptom Scale PSS-I is a 17-item semi-structured interview

that assesses the presence and severity of DSM-IV PTSD symptoms related to a single identified traumatic event in individuals with a known trauma history.

The PSS-I takes about 20 minutes to administer and can be administered by lay interviewers trained to recognize the clinical picture in traumatized persons. Each item is assessed with a brief, single question (PTSD: National Center for PTSD, n.d.)

Inter-rater Reliability is high

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DATA COLLECTED: VALIDITY & RELIABILITY

Participants all be given the same Questionnaires, given the same instruction on how to fill it out, and will be encouraged to answer honestly in order to ensure validity and reliability.

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PSS-I CAPS-5

SCHEDULE This study is designed to last for one year, with quarterly

evaluations & observations of symptoms.

At each quarterly evaluation, serum drug screens will be performed on each participant to help control extraneous variables. Additionally complete blood count and chemistry panels will be performed to establish a baseline results. Blood test results will be monitored throughout the duration of the study to monitor the over all health of each patient.

The study will conclude with a final post-test evaluation.

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DATA ANALYSIS

Since two mean scores will be compared , a t- test will be used. Control group will be receiving placebo treatment Experimental group will be receiving the medical marijuana treatment Both of these groups will be compared to establish if there is a difference

between the mean of the control group and the mean of the experimental group.

The results of this study will be presented using graphical and tabular form to illustrate, independently, how each group changed.

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PLAN / TIME SCHEDULE

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Participants will be evaluated and tested at quarterly intervals for one year. During which, the CAPS-5 and the PSS-I questionnaires will be administered.

Blood tests will be performed at every interval beginning with Q1. which include : Drug Screen Standard 9-Panel, Complete Blood Count Panel, and a Comprehensive Metabolic Panel.

DISCUSSION: SIGNIFICANCE AND FEASABILITY Significance:

This study is significant because it has the potential to identify Medical marijuana as an effective treatment for PTSD related symptoms.

Feasibility: This study is feasible because:

It is not difficult to implement Methodology listed is easy to replicate Study is cost effective. The benefits of the study outweigh the risks. Time length of the study is appropriate.

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THREATS TO EXTERNAL VALIDITY

Selection-treatment interactionSome characteristic of the participants selected for study could interact

with some aspect of the treatment.Can include prior experiences, personality factors, or any other traits

that could interact with the effect of the treatment.

Experimenter EffectsThe possibility the an experimenter may influence the performance of

the participants in the study (Neutens, 2014).

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LIMITATIONS Limitations:

This study does not address the effectiveness of medical marijuana on PTSD symptoms for individuals who have suffered from long term PTSD.

This study does not address the effectiveness of medical marijuana on PTSD symptoms for minors with PTSD.

This study does not address the effectiveness of medical marijuana on PTSD symptoms for individuals who also take other prescribed medication.

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