Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression
Condition: Cocaine Dependence; Depression
MeSH terms: Cocaine-Related Disorders; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Many substance dependent individuals also suffer from depression. Past research suggests that
      antidepressant medication is helpful in treating such individuals. This study will determine
      the effectiveness of mirtazapine, an antidepressant medication, in treating cocaine dependent
      individuals who also suffer from depression. This study includes free treatment for cocaine
      dependence that includes medication and a behavioral intervention.
    

Detailed description: 
      Cocaine abuse and depression often occur together. Individuals suffering from both are
      usually not able to quit abusing cocaine. Past research conducted on alcohol dependent
      individuals also suffering from depression showed that these individuals were able to
      successfully quit drinking with the addition of an antidepressant medication. Mirtazapine is
      a medication currently used to treat depression. This study will evaluate the efficacy of
      mirtazapine, used in combination with behavioral therapy, in treating cocaine dependent
      individuals who also suffer from depression.

      Participants in this 8-week trial will be randomly assigned to receive either mirtazapine or
      placebo. Prior to starting medication treatment, participants will undergo an initial 2-week
      phase consisting of psychosocial and behavioral therapy. The purpose of this lead-in phase is
      to achieve initial reduction or abstinence in cocaine use, while observing cocaine withdrawal
      symptoms and mood changes associated with depression. During these first 2 weeks,
      participants will attend three study visits each week, at which time they will participate in
      motivational interviews and cognitive behavioral relapse prevention therapy. During this
      phase, participants who successfully remain abstinent from cocaine use will be rewarded with
      high-value monetary vouchers.

      Upon completing the lead-in phase, participants will be randomly assigned to receive either
      mirtazapine or placebo. Participants will attend study visits twice each week for 8 weeks.
      Mood and drug use will be evaluated at each study visit. Cognitive behavioral relapse
      prevention therapy will continue throughout the study. In addition, participants will earn
      low-value monetary vouchers contingent on cocaine abstinence.

      At the end of Week 8, participants will enter the lead-out phase. At this time, those
      participants whose mood has significantly improved will be able to continue treatment for an
      additional 8 weeks. Participants whose mood has not shown improvement will be tapered off
      their assigned medication treatment and will be offered treatment with an alternative
      medication. Following completion of the lead-out phase, all participants will be referred for
      continuing care in the community.
    

Intervention name(s): Mirtazapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Mirtazapine; placebo
Other intervention name(s): Remeron
Intervention MeSH terms: Mirtazapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine dependence; mirtazipine