New Approaches to Cocaine Abuse Medications (A) - 6

Phase 2

Completed

• Conditions: Cocaine-Related Disorders; Substance-Related Disorders
• Interventions: Drug: Placebo; Drug: Desipramine

• Registration Number: NCT00000271
• Lead Sponsor: New York State Psychiatric Institute

Brief 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.

Study Timeline

• Study Start: 1995-01
• Study First Submitted: 1999-09-20
• Study First Submitted QC: 1999-09-20
• Study First Posted: 1999-09-21
• Primary Completion: 2002-10
• Study Completion: 2002-10
• Status Verified: 2017-06
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants were treated with matching placebo. All patients received weekly individual manual-guided relapse prevention therapy.
Desipramine	Desipramine	Participants were treated with desipramine, up to 300 mg per day. All patients received weekly individual manual-guided relapse prevention therapy.

Primary Outcome Measures

Name	Time	Method
Cocaine Use	Weekly over a 12 week period.	Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology.
Depression	Bi-weekly over a 12 week period.	Hamilton Depression Scale

Trial Locations

Locations (1)

Research Foundation for Mental Hygiene; 🇺🇸 New York, New York, United States