Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence - 1
Condition: Alcoholism; Cocaine Dependence
MeSH terms: Alcoholism; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see whether naltrexone is safe and useful in preventing
      alcohol relapse, as well as in decreasing craving for alcohol in people with a diagnosis of
      alcohol and cocaine dependence. Naltrexone is approved by the Food and Drug Administration
      (FDA) for the treatment of alcohol dependence. However, the medication was not approved as
      yet at the dosage we will use in this study. The dosage we will use for the study (150 mg),
      is greater than the recommended dosage from the Physician's Desk Reference (50mg). Unlike
      other medicines (like Antabuse) useful in the treatment of alcohol dependence, naltrexone
      will not make you sick if you drink alcohol. Rather, people who are taking this medication
      have reported that it helps decrease the pleasure associated with drinking for them. This
      study is being conducted because the medication (Naltrexone) has not been well studied in
      people with both alcohol and cocaine dependence, so it is still investigational.

      We believe that if we can reduce alcohol consumption through naltrexone and psychotherapy,
      this may lead to reduced cocaine use. We are also conducting this study to test two different
      types of psychotherapy as a method for reducing cocaine and alcohol use. One type of
      psychotherapy, CBT, is designed to help people learn to cope with situations that put them at
      high risk for relapse to cocaine and/or alcohol use. The other type of psychotherapy, BRENDA,
      will use focuses on strengthening motivation to recover from cocaine and/or alcohol use, and
      on developing techniques to handle possible barriers to recovery. We seek to enroll 300
      patients in the study.
    

Detailed description: 
      The project will use a 2x2 design to assess the efficacy of naltrexone for treating subjects
      who are both cocaine and alcohol dependent and who will receive either CBT or BRENDA alone or
      in combination with naltrexone. There will be 300 DSM-IV cocaine-alcohol dependent male and
      female subjects randomized to one of four groups (75 subjects per group). Subjects will be
      randomized to either 150mg/day naltrexone or placebo and to receive either CBT (a type of
      cognitive behavior therapy derived from relapse prevention principles), or a new primary-care
      basedmodel, BRENDA, comprised of strategies for enhancing motivation and treatment
      compliance. All subjects will receive one of the four combinations of medication and
      psychosocial treatment. The length of the study for each subject includes one week of
      screening/baseline assessments, 12 weeks of double-blind, placebo-controlled naltrexone
      treatment combined with one of two psychosocial treatments, and a 6-month and 12-month
      follow-up visit. Following successful completion of detoxification (abstinence from alcohol
      and cocaine for 7 days), informed consent will be signed, and Week 1 will be devoted to
      completing screening and baseline measures. In Week 2, subjects will be randomly assigned to
      medication/ psychosocial treatment combination. Following completion of the 12-week,
      double-blind treatment trial, subjects will be evaluated at 6-month and 12-months
      post-treatment visits.
    

Intervention name(s): Naltrexone; BRENDA; CBT; Placebo
Intervention type(s): Drug; Behavioral; Behavioral; Drug
Intervention description(s): 150mg/day Naltrexone; Psychosocial Treatment; Cognitive Behavioral Therapy
Other intervention name(s): 150mg/day Placebo
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment