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Integrated Treatment for Cocaine and Mood Disorders - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00227812
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief 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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Depressive Disorder, Major Drug: Bupropion Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: ERP-8654 - Integrated Treatment for Cocaine and Mood Disorders
Study Start Date : April 2001
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mood Disorders




Primary Outcome Measures :
  1. Urine toxicology for cocaine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227812


Locations
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United States, Texas
University of Texas Health Sci Cntr Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Joy Schmitz, Ph.D. The University of Texas Health Science Center, Houston
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Responsible Party: Joy Schmitz, PhD, University of Texas Hlth Sci Ctr Houston
ClinicalTrials.gov Identifier: NCT00227812    
Other Study ID Numbers: NIDA-08654-1
R01-DA08654-1
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2009
Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Depressive Disorder
Mood Disorders
Depressive Disorder, Major
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors