Integrated Treatment for Cocaine and Mood Disorders - 1

Depressive Disorder, Major Clinical Trial

Official title:

ERP-8654 - Integrated Treatment for Cocaine and Mood Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227812
• Other study ID #: NIDA-08654-1
• Secondary ID: R01-DA08654-1
• Status: Completed
• Phase: Phase 2
• First received: September 27, 2005
• Last updated: January 11, 2017
• Start date: April 2001
• Est. completion date: December 2005

Study information

• Verified date: January 2009
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Mood Disorders

Intervention

Drug:
• Bupropion

Locations

Country	Name	City	State
United States	University of Texas Health Sci Cntr Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine toxicology for cocaine