cctn september 6 th, 2011. recent scientific publications from the clinical trials network david...

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)


Results

Prolonged abstinence rates by nicotine dependence level (FTND), ADHD subtype, and randomized treatment:


3-way interaction: χ2(1) = 8.22, p < .01

Pro

longed

Abst

inence

%

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


• Bullet text in White



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


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


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%)


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


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)


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


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


cctn september 6 th, 2011. recent scientific publications from the clinical trials network david...

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