Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects
Condition: Cocaine Dependence; Depression
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study is being done to look at the safety of the medication Mirtazapine
      (Remeron) in people who have cocaine dependence and depression. Hypotheses I. Cocaine usage
      will be less in the mirtazapine treatment group (MG) than in the control group (CG). II. A
      greater increase in Clinician Global Impression (CGI) score will be observed in the MG than
      in the CG. Secondary Hypotheses: I. A greater decrease in Hamilton Rating Scale for
      Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) scores will be observed in
      the MG than in the CG. II. A greater decrease in HIV risk behaviors will be observed in the
      MG than in the CG. III. A greater improvement in sleep structure will be observed in the MG
      than in the CG. IV. The proportion of subjects experiencing severe adverse drug reactions
      that necessitate termination from the study by one of the study clinicians will not differ
      between the MG and CG. V. Retention will be greater in MG than in CG.
    

Detailed description: 
      Cocaine dependence is a significant public health problem associated with serious medical,
      psychiatric, social and economic consequences. It is generally accepted that the euphoria
      associated with cocaine use is a result of its action on reward pathways via antagonist
      properties at the dopamine transporter site; cocaine also inhibits reuptake of serotonin and
      norepinephrine. These actions are thought to underlie cocaine's potent reinforcing
      properties. With prolonged use, cocaine may deplete these neurotransmitters, affect
      postsynaptic receptor density, and elicit an overall dysregulation of these neurotransmitter
      systems. These longer term consequences may account for the post-cocaine depressive symptoms
      often claimed by cocaine users to contribute to relapse. Treatment for cocaine dependence at
      the present is primarily psychosocial/behavioral. Currently there is no pharmacological agent
      approved for treatment of cocaine dependence in conjunction with psychosocial interventions.
      Several drugs currently approved for other indications are presently under consideration for
      treatment of cocaine dependence based on their known mechanisms and sites of action. Current
      approaches include strategies to (1) block the effects of cocaine, (2) substitutes for
      cocaine, (3) reduce craving or enhance the addict's ability to manage his/her response to
      craving, and (4) treat underlying conditions (or consequences of cocaine use) that may
      predispose toward dependence.
    

Intervention name(s): Placebo; Mirtazapine
Intervention type(s): Other; Drug
Intervention description(s): Placebo for days 1-4 Placebo for days 5-9 Placebo for days10-78 Placebo for days 79-81 Placebo for days 82-84; Days 1-4 15mg Days 5-9 30 mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg
Other intervention name(s): Remeron
Intervention MeSH terms: Mirtazapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cocaine; Substance Abuse