NCT00322309

Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects

The Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cocaine Dependence
• Depression

Interventions

Type	Name	Description
OTHER	Placebo	Placebo for days 1-4 Placebo for days 5-9 Placebo for days10-78 Placebo for days 79-81 Placebo for days 82-84
DRUG	Mirtazapine	Days 1-4 15mg Days 5-9 30 mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg

Timeline

• Start date: 2005-09-01
• Primary completion: 2009-07-01
• Completion: 2010-02-01
• First posted: 2006-05-05
• Last updated: 2017-04-20
• Results posted: 2017-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study