Integrated Treatment for Cocaine and Mood Disorders - 1

Study Overview
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Brief Summary
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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
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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.

Official Title
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ERP-8654 - Integrated Treatment for Cocaine and Mood Disorders

Conditions
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Cocaine Dependence, Depressive Disorder, Major

Intervention / Treatment
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* Drug: Bupropion


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bupropion|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine toxicology for cocaine |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cocaine dependence