NCT00000271

New Approaches to Cocaine Abuse Medications (A) - 6

New Approaches to Cocaine Abuse Medications (A)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to measure the effect of desipramine in cocaine abusers selected for major depression or dysthymia.

Detailed description

This is a randomized, 12-week, double-blind, 'placebo-controlled trial of outpatients meeting DSM-III-R criteria for cocaine dependence and major depression or dysthymia (by SCID interview). Participants were treated with desipramine, up to 300 mg per day, or matching placebo. All patients received weekly individual manual-guided relapse prevention therapy. Weekly outcome measures included the Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology, and the Hamilton Depression Scale.

Conditions

• Cocaine-Related Disorders
• Substance-Related Disorders

Interventions

Type	Name	Description
DRUG	Desipramine	Participants were treated with desipramine, up to 300 mg per day, or matching placebo. All participants received weekly individual manual-guided relapse prevention therapy.
DRUG	Placebo	Participants were treated with matching placebo. All participants received weekly individual manual-guided relapse prevention therapy.

Timeline

• Start date: 1995-01-01
• Primary completion: 2002-10-01
• Completion: 2002-10-01
• First posted: 1999-09-21
• Last updated: 2017-07-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study