Integrated Treatment for Cocaine and Mood Disorders - 1
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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) |
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 |
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| United States, Texas | |
| University of Texas Health Sci Cntr Houston | |
| Houston, Texas, United States, 77030 | |
| 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:
|
Depressive Disorder Depression Mood Disorders Cocaine-Related Disorders Depressive Disorder, Major Mental Disorders Behavioral Symptoms Substance-Related Disorders Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents |
Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013