Integrated Treatment for Cocaine and Mood Disorders - 1

NCT ID: NCT00227812

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2005-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Bupropion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Generally physically healthy
• Aged 18-55
• Meets cocaine dependence by DSM-IV criteria
• Meets major depressive disorder or substance-induced depression disorder by DSM-IV criteria.
• Willing and able to participate in the 12 week treatment study and one year follow up.

Exclusion Criteria

• Pregnant or breastfeeding.
• Taking medications that interact with the study medication (MAO inhibitors, anticonvulsants, haloperidol, phenothiazines,selegiline, anesthetics
• Have other psychiatric diagnoses requiring therapy or medication.
• Physically dependent on opiates or alcohol.
• Currently being treated with bupropion hydrochloride (e.g. Zyban).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

University of Texas Hlth Sci Ctr Houston

Principal Investigators

Joy Schmitz, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

University of Texas Health Sci Cntr Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

R01-DA08654-1

Identifier Type: -

Identifier Source: secondary_id

R01DA008654

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDA-08654-1

Identifier Type: -

Identifier Source: org_study_id