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CCTN September 6 th , 2011

CCTN September 6 th , 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

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CCTN September 6 th , 2011

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  1. CCTNSeptember 6th, 2011

  2. 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

  3. Divergence by ADHD Subtype in Smoking Cessation Response to OROS-Methylphenidate Lirio S. Covey et al. Nicotine & Tobacco Research Available online June 7, 2011 CTN-0029

  4. 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 Covey et al., Nicotine & Tobacco Research 2011 CTN-0029

  5. 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) Covey et al., Nicotine & Tobacco Research 2011 CTN-0029

  6. Results Prolonged Abstinence % • 3-way interaction: χ2(1) = 8.22, p < .01 Prolonged abstinence rates by nicotine dependence level (FTND), ADHD subtype, and randomized treatment: Covey et al., Nicotine & Tobacco Research 2011 CTN-0029

  7. 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 Covey et al., Nicotine & Tobacco Research 2011 CTN-0029

  8. Bullet text in White • Bullet text in White • Bullet text in White CTN-0015

  9. 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.2011.06.014 CTN-0015

  10. Newspaper Ads vs. Clinic Recruits • Study compares participants at 1 site • N = 70 recruited from newspaperadvertisements • N = 36 recruited directly from clinic patients CTN-0015

  11. Newspaper Ads vs. Clinic Recruits • Study compares participants at 1 site • N = 70 recruited from newspaperadvertisements • N = 36 recruited directly from clinic patients • Examines relationship of recruitment with • sample characteristics • treatment outcomes Winhusen, T., et al., Drug Alcohol Depend. (2011) doi:10.1016/j.drugalcdep.2011.06.014 CTN-0015

  12. 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 Winhusen, T., et al., Drug Alcohol Depend. (2011) doi:10.1016/j.drugalcdep.2011.06.014 CTN-0015

  13. 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 Winhusen, T., et al., Drug Alcohol Depend. (2011) doi:10.1016/j.drugalcdep.2011.06.014 CTN-0015

  14. Special CTN Edition Volume 37, Number 5 (September 2011) http://informahealthcare.com/toc/ada/current

  15. CTN Secondary Analysis

  16. Objectives To examine the prevalence of alcohol use disorders among primary stimulant-misusing treatment-seekers 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)

  17. 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)

  18. Results: Primary Cocaine Misusers 48% had AUD comorbidity Those with AUD were more likely to: show elevated ASI composite scores perceive greater importance of drug treatment endorse psychiatric symptoms and perceived need for their (psychiatric) treatment Hartzler, B., et al., AM J Drug and Alcohol Abuse 37: 460-471 (2011)

  19. 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)

  20. 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)

  21. 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)

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