Transcript CCTN September 6th, 2011 - CTN Dissemination Library

CCTN
th
September 6 , 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 Research
Available 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
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CTN-0029
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
Results
Prolonged Abstinence %
Prolonged abstinence rates by nicotine dependence level
(FTND), ADHD subtype, and randomized treatment:
3-way
interaction:
χ2(1) = 8.22,
p < .01
CTN-0029
Covey et al., Nicotine & Tobacco Research 2011
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.2011.06.014
Newspaper Ads vs. Clinic
Recruits
• Study compares participants at 1 site
– N = 70 recruited from newspaper advertisements
– N = 36 recruited directly from clinic patients
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
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
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
Winhusen, T., et al., Drug Alcohol Depend. (2011) doi:10.1016/j.drugalcdep.2011.06.014
Volume 37,
Number 5
(September 2011)
http://informahealthcare.com/toc/ada/current
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:
Stimulant misusers:
4,396 participants
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1,133 (26%)
With data on alcohol use:
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993 (88%)
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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 pretreatment 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)