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Integrated Treatment for Cocaine and Mood Disorders - 1

ERP-8654 - Integrated Treatment for Cocaine and Mood Disorders

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00227812
Enrollment
140
Registered
2005-09-28
Start date
2001-04-30
Completion date
2005-12-31
Last updated
2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine Dependence, Depressive Disorder, Major

Keywords

cocaine dependence

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.

Interventions

DRUGBupropion

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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).

Design outcomes

Primary

MeasureTime frame
Urine toxicology for cocaine

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026