Efficacy of Varenicline in Methadone-Stabilized Cocaine Users
Condition: Cocaine Dependence; Nicotine Dependence
MeSH terms: Tobacco Use Disorder; Cocaine-Related Disorders
Study type: Interventional

Summary: 
      Cocaine addiction continues to be an important public health problem in the US with a
      significant cost to the individual and society. Among substance abusers, cocaine use has been
      recognized as a significant problem especially in methadone-maintenance patients. In several
      studies, rates of cocaine use have been reported to range from 30 to over 60 percent of those
      in methadone maintenance programs (Condelli et al. 1991; Hunt et al. 1984; Kidorf and Stitzer
      1993; Kosten et al. 1988). In these patients, cocaine use seems to be a predictor of poor
      clinical outcome (Hartel et al. 1995; Kosten et al. 1987a). The development of effective
      pharmacotherapies for cocaine use disorders, especially in the opioid-dependent population is
      of great importance. Unfortunately, such effective pharmacotherapies do not exist.

        1. To determine the safety and tolerability of varenicline in cocaine-using
           methadone-stabilized subjects.

        2. To determine if varenicline is efficacious in reducing cocaine-use in
           methadone-stabilized subjects.
    

Detailed description: 
      For this pilot study, we hope to recruit a total of 40 subjects, with 20 subjects in the
      varenicline group, and 20 into the placebo-control group. Assuming significant findings,
      these data will enable us to estimate a possible effect size for carrying-out a larger study.
      For preliminary analysis as a prelude to planning larger controlled studies, we will
      clinically require an effect size of 20% differences in the rates of cocaine positive urines
      or of self-reported cocaine use between the active medication and placebo groups. We will not
      adjust for these multiple comparisons to the placebo group since this is a pilot study, and
      use two-tailed significance level of 0.05 when we employ repeated measures analysis of
      variance (ANOVA) or Hierarchical Linear Modeling (HLM,see below) for statistical analysis
      over the 16-week study period.

      An Amendment was made and a new Updated consent form to include new FDA findings for study
      medication Varenicline." Varenicline may also cause changes in behavior, agitation, depressed
      mood, suicidal ideation and suicidal behavior." Currently we have 30 subjects who have
      completed this study. This study is suspended due to these new concerns, Department of
      Veterans Affairs and the P.I. James Poling agreed.

      Study has been published. (April 2011)
    

Intervention name(s): Varenicline; Sugar pill or Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Varenicline up to 2 mg a day; Placebo
Other intervention name(s): Chantix; Sugar pill
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: varenicline