Viewing Study NCT00227812



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Last Modification Date: 2024-10-26 @ 9:19 AM
Study NCT ID: NCT00227812
Status: COMPLETED
Last Update Posted: 2017-01-12
First Post: 2005-09-27

Brief Title: Integrated Treatment for Cocaine and Mood Disorders - 1
Sponsor: National Institute on Drug Abuse NIDA
Organization: National Institute on Drug Abuse NIDA

Study Overview

Official Title: ERP-8654 - Integrated Treatment for Cocaine and Mood Disorders
Status: COMPLETED
Status Verified Date: 2009-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 ie 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01-DA08654-1 None None None