VIVITROL as a Treatment for Cocaine and Alcohol Dependence
Condition: Cocaine Dependence; Alcohol Dependence
MeSH terms: Alcoholism; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of VIVITROL (naltrexone for extended-release injectable suspension)
      for the treatment of co-occurring cocaine and alcohol dependence
    

Detailed description: 
      This is a Phase II double-blind randomized controlled clinical pilot study. The exploratory
      objectives in the proposed study will be examined with a 2-group design to assess the
      efficacy of naltrexone extended-release injectable suspension (VIVITROL™) as compared to
      placebo. Safety measures will be collected weekly through medical management (MM) by medical
      practitioners, including adverse events and concomitant meds. The psychosocial treatment will
      be Cognitive Behavioral Coping Skills Therapy (CBT). Subjects will be 80 men and women with
      current DSM-IV diagnoses of alcohol dependence and cocaine dependence that will be randomized
      to receive either VIVITROL or placebo (40 subjects per group). All subjects will receive
      weekly sessions of CBT and MM. The study length for each subject is comprised of 1-3 weeks of
      screening, an 8-week double-blind, placebo-controlled trial with MM and CBT (medication
      phase), and an end of medication visit.

      Primary Exploratory Objectives:

        -  To compare medication groups' rates of cocaine abstinence, as determined by urine assay
           for benzoylecgonine (BE), the primary metabolite of cocaine. This will be cross-checked
           against participants' self-reports of cocaine use through Time-Line Follow Back
           (TLFB)(Sobell & Sobell, 1992).

        -  To compare medication groups' rates of abstinence from drinking, and of clinically
           significant drinking, as measured by the TLFB.

      Secondary Exploratory Objectives:

        -  To evaluate medication groups' reports of craving for cocaine and alcohol, as measured
           by scores on the Penn Alcohol Craving Scale and the Minnesota Cocaine Craving Scale
           during the medication treatment phase.

        -  To compare women's reports of medication tolerance of naltrexone extended-release
           injectable suspension versus high dose oral naltrexone that was reported in our recently
           published pilot trial of high dose naltrexone for dual cocaine and alcohol dependence
           (Pettinati et al., 2008).
    

Intervention name(s): VIVITROL (Naltrexone extended-release injectable suspension); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6.; Placebo injection at the start of weeks 2 and 6.
Other intervention name(s): Vivitrol
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: alcohol; cocaine; addiction; alcoholism; substance dependence; substance abuse