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Integrated Treatment for Cocaine and Mood Disorders - 1

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00227812
First received: September 27, 2005
Last updated: January 7, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Cocaine Dependence
Depressive Disorder, Major
Drug: Bupropion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: ERP-8654 - Integrated Treatment for Cocaine and Mood Disorders

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Urine toxicology for cocaine

Estimated Enrollment: 140
Study Start Date: April 2001
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227812

Locations
United States, Texas
University of Texas Health Sci Cntr Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Joy Schmitz, Ph.D. The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Joy Schmitz, PhD, University of Texas Hlth Sci Ctr Houston
ClinicalTrials.gov Identifier: NCT00227812     History of Changes
Other Study ID Numbers: NIDA-08654-1, R01-DA08654-1
Study First Received: September 27, 2005
Last Updated: January 7, 2009
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Mood Disorders
Behavioral Symptoms
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014