CCTN September 6 th , 2011
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Transcript of CCTN September 6 th , 2011
CCTNSeptember 6th, 2011
Recent Scientific Publications from the Clinical Trials Network
David Liu, M.D. (CTN-0029)
Harold Perl, Ph.D. (CTN-0015)
Paul Wakim, Ph.D. (Secondary analysis of 8 CTN trials)
Betty Tai, Ph.D. Director
Divergence by ADHD Subtype in Smoking Cessation Response to OROS-Methylphenidate
Lirio S. Covey et al.Nicotine & Tobacco ResearchAvailable online June 7, 2011
CTN-0029 Clinical Trial
• Double-blind, randomized clinical trial for adult smokers with ADHD• n = 255; 6 sites• Osmotic-release methylphenidate (OROS-MPH)
vs. placebo for 11 weeks• Nicotine patches and weekly smoking
cessation counseling
• Primary outcome: No improvement in prolonged abstinence rate, OROS-MPH vs. placebo
CTN-0029 Covey et al., Nicotine & Tobacco Research 2011
Covey et al. Logistic Regression Model
• Dependent variable: Prolonged abstinence• Independent variables:
• ADHD subtype (inattentive vs. hyperactive/impulsive or combined)
• Total ADHD symptoms at baseline• Nicotine dependence level (Fagerström)• Smoking history• Psychiatric history• Demographic characteristics• Randomized treatment (OROS-MPH vs.
placebo)
CTN-0029 Covey et al., Nicotine & Tobacco Research 2011
Results
Prolonged abstinence rates by nicotine dependence level (FTND), ADHD subtype, and randomized treatment:
CTN-0029 Covey et al., Nicotine & Tobacco Research 2011
3-way interaction: χ2(1) = 8.22, p < .01
Prol
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Implications
• Assessment of ADHD subtype and of nicotine dependence level could be part of a personalized treatment approach for smokers with ADHD
• Highly nicotine dependent smokers with ADHD, hyperactive-impulsive or combined subtype, may benefit from OROS-MPH treatment
• OROS-MPH may not be a treatment of choice for highly nicotine dependent smokers with ADHD, inattentive subtype
CTN-0029 Covey et al., Nicotine & Tobacco Research 2011
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Recruitment Affects Sample
• Clinical trials recruit directly from treatment programs or through general advertising
• Recruitment method can impact sample composition – and generalizability – of a trial
• Little study of this in SUD trials
• Particularly few data on relationship between recruitment and outcome
Winhusen, T., et al., Drug Alcohol Depend. (2011) doi:10.1016/j.drugalcdep.2011.06.014CTN-0015
Newspaper Ads vs. Clinic Recruits
• Study compares participants at 1 site – N = 70 recruited from newspaper advertisements – N = 36 recruited directly from clinic patients
CTN-0015
Newspaper Ads vs. Clinic Recruits
• Study compares participants at 1 site – N = 70 recruited from newspaper advertisements – N = 36 recruited directly from clinic patients
• Examines relationship of recruitment with– sample characteristics – treatment outcomes
CTN-0015 Winhusen, T., et al., Drug Alcohol Depend. (2011) doi:10.1016/j.drugalcdep.2011.06.014
Recruiting Method & Treatment Effectiveness
• Ad recruits had higher levels of drug use and PTSD at baseline than clinic recruits
• Seeking Safety was more effective for ad recruits in reducing PTSD than for clinic recruits (although SS effective for all)
• Seeking Safety was more effective for clinic recruits in reducing past week drug use at follow-up
CTN-0015 Winhusen, T., et al., Drug Alcohol Depend. (2011) doi:10.1016/j.drugalcdep.2011.06.014
Implications for Study Design
• Recruitment method can affect – Sample characteristics– Treatment effectiveness– Trial generalizability
• Important to take recruiting methods into account during study design phase
CTN-0015 Winhusen, T., et al., Drug Alcohol Depend. (2011) doi:10.1016/j.drugalcdep.2011.06.014
SPECIALCTN EDITION
http://informahealthcare.com/toc/ada/current
Volume 37, Number 5 (September 2011)
Objectives
1) To examine the prevalence of alcohol use disorders among primary stimulant-misusing treatment-seekers
2) To examine the impact of alcohol use disorder comorbidity on their pre-treatment psychosocial functioning
Hartzler, B., et al., AM J Drug and Alcohol Abuse 37: 460-471 (2011)
Results: Prevalence of alcohol use disorder
Total from 8 trials: 4,396 participants Stimulant misusers: 1,133 (26%) With data on alcohol use: 993 (88%) With AUD comorbidity: 449 (45%)
Hartzler, B., et al., AM J Drug and Alcohol Abuse 37: 460-471 (2011)
Results: Primary Cocaine Misusers
48% had AUD comorbidity
Those with AUD were more likely to:
1) show elevated ASI composite scores
2) perceive greater importance of drug treatment
3) endorse psychiatric symptoms and perceived need for their (psychiatric) treatment
Hartzler, B., et al., AM J Drug and Alcohol Abuse 37: 460-471 (2011)
Results: Primary Amphetamine Misusers
35% had AUD comorbidity
Those with AUD were more likely to endorse specific psychiatric symptoms (dyscontrol of violence, suicidal ideation and attempted suicide)
Hartzler, B., et al., AM J Drug and Alcohol Abuse 37: 460-471 (2011)
Conclusion
• AUD comorbidity is a fairly common diagnostic feature of primary stimulant misusers
• AUD has a pervasive influence on the pre-treatment psychosocial functioning of cocaine misusers
Hartzler, B., et al., AM J Drug and Alcohol Abuse 37: 460-471 (2011)
Conclusion
In addiction treatment research:
• Include a comprehensive diagnostic assessment
• Stratify by diagnostic variables
In clinical practice:
• Comprehensively diagnose substance use disorders in treatment intake and treat accordingly
Hartzler, B., et al., AM J Drug and Alcohol Abuse 37: 460-471 (2011)