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Completed

NCT Number: NCT00227812

Integrated Treatment for Cocaine and Mood Disorders - 1

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas Health Sci Cntr Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

bupropion

Drug

Primary outcomes

  1. Urine toxicology for cocaine

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

ERP-8654 - Integrated Treatment for Cocaine and Mood Disorders

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Sep 28, 2005
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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