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Integrated Treatment for Cocaine and Mood Disorders - 1

Primary Purpose

Cocaine Dependence, Depressive Disorder, Major

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupropion
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring cocaine dependence

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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).

Sites / Locations

  • University of Texas Health Sci Cntr Houston

Outcomes

Primary Outcome Measures

Urine toxicology for cocaine

Secondary Outcome Measures

Full Information

First Posted
September 27, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00227812
Brief Title
Integrated Treatment for Cocaine and Mood Disorders - 1
Official Title
ERP-8654 - Integrated Treatment for Cocaine and Mood Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence, Depressive Disorder, Major
Keywords
cocaine dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
140 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bupropion
Primary Outcome Measure Information:
Title
Urine toxicology for cocaine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy Schmitz, Ph.D.
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Sci Cntr Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Integrated Treatment for Cocaine and Mood Disorders - 1

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