Venlafaxine to Reduce Cocaine Dependence in Depressed Individuals
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Preliminary research has shown that venlafaxine, a medication currently used for treating
      depression, may also discourage cocaine use in depressed individuals. This study will
      evaluate the effectiveness of venlafaxine in reducing cocaine use and alleviating depression
      in individuals addicted to cocaine.
    

Detailed description: 
      Individuals addicted to cocaine often experience feelings of restlessness, irritability, and
      anxiety. They also often report feeling depressed when not using cocaine, and they tend to
      resume cocaine use to alleviate symptoms of depression. Venlafaxine is a medication that is
      currently used to treat depression and anxiety disorders. Preliminary research has shown that
      venlafaxine reduces depression, improves mood, and simultaneously reduces cocaine use in
      cocaine addicts. Further research is needed to confirm the benefits of venlafaxine for
      cocaine addicts. The purpose of this study is to evaluate the effectiveness of venlafaxine in
      reducing cocaine use, cocaine craving, and depression in individuals who are addicted to
      cocaine and diagnosed with depression.

      This study will begin with a 1-week lead-in phase, during which all participants will receive
      placebo medication. Participants whose depression levels decrease will not continue in the
      treatment phase of the study, but will be eligible for cocaine relapse therapy and medication
      if deemed necessary by the treating psychiatrist. Participants who remain depressed following
      the lead-in phase will be randomly assigned to receive either venlafaxine or placebo for 12
      weeks. Participants assigned to venlafaxine will initially receive a daily dose of 37.5 mg.
      After 4 days, the dose will be increased to 75 mg; each week thereafter, the dose will be
      increased by another 75 mg, up to a maximum of 300 mg per day, dependent on side effects and
      positive responses. Study visits will take place twice a week. At each visit, medication side
      effects and depression levels will be assessed, cocaine levels will be monitored with urine
      tests, and self-reports will be completed. Blood will be drawn once per month for laboratory
      tests. Participants will also attend a therapy session once a week, and they will meet with a
      psychiatrist every other week for assessments. Participants who show a decrease in depression
      during the 12 weeks of treatment will continue for an additional 12 weeks to further monitor
      cocaine use and depression levels.
    

Intervention name(s): Venlafaxine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Venlafaxiine 300mg/day; Placebo
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cocaine Addiction; Cocaine Dependence