Integrated Treatment for Cocaine and Mood Disorders - 1

National Institutes of Health (NIH)

Status and phase

Completed

Phase 2

Conditions

Cocaine Dependence

Depressive Disorder, Major

Treatments

Drug: Bupropion

Study type

Interventional

Funder types

NIH

Identifiers

NCT00227812

R01-DA08654-1

NIDA-08654-1

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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).