NCT00227812

Integrated Treatment for Cocaine and Mood Disorders - 1

ERP-8654 - Integrated Treatment for Cocaine and Mood Disorders

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (planned)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test whether cognitive behavioral therapy and bupropion hydrochloride will help cocaine users, who are depressed, reduce or end their cocaine use and improve their mood.

Detailed description

The global aim of this study is to evaluate an "integrated" treatment approach for cocaine dependent patients with comorbid unipolar depression. It is hypothesized that a cognitive-behavioral psychotherapy that targets both disorders, in combination with a pharmacotherapy, i.e., bupropion, is expected to provide the best coverage for dual disorders and thus maximize treatment outcomes. Specifically, we will conduct a double blind, placebo-controlled clinical trial involving the random assignment of participants into one of four treatment conditions according to a full 2x2 factorial research design. One independent variable will be pharmacotherapy (bupropion versus placebo); the other independent variable will be psychotherapy (integrated CBT versus clinical management). The study will enroll 140 cocaine dependent patients with comorbid major depressive disorder. A secondary objective is to further elucidate "primary" and "secondary" paradigms of depressive illness symptoms in cocaine-dependent adults and better understand how this distinction influences treatment outcome. This will be accomplished by enrolling a subsample of patients with substance-induced mood disorder. Taken together, this proposal will examine the feasibility and relative efficacy of a novel integrated treatment model for dually-diagnosed patients.

Conditions

• Cocaine Dependence
• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Bupropion

Timeline

• Start date: 2001-04-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2005-09-28
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States