Integrated Treatment for Cocaine and Mood Disorders - 1



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD), Psychiatric, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 55
Updated:1/13/2017
Start Date:April 2001
End Date:December 2005

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ERP-8654 - Integrated Treatment for Cocaine and Mood Disorders

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.

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.

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).
We found this trial at
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Houston, TX
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