Baclofen for the Treatment of Cocaine Dependence - 1

This study has been completed.

Sponsor:

Information provided by:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00082485

First received: May 11, 2004

Last updated: May 14, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 11, 2004

Last Updated Date

May 14, 2009

Start Date ^ICMJE

June 2004

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Effects of medication on cocaine craving

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00082485 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Baclofen for the Treatment of Cocaine Dependence - 1

Official Title ^ICMJE

Multi-Center Trial of Baclofen for the Treatment of Cocaine Dependence

Brief Summary

The purpose of this study is to assess the efficacy and safety of baclofen for the treatment of cocaine dependence.

Detailed Description

Double-blind, placebo-controlled, parallel design trial of baclofen for the treatment of cocaine dependence

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Cocaine-Related Disorders

Intervention ^ICMJE

Drug: Baclofen
Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)
Other: Placebo
Placebo

Study Arm (s)

Active Comparator: 1
Intervention: Drug: Baclofen
Placebo Comparator: 2
Intervention: Other: Placebo

Publications *

Kahn R, Biswas K, Childress AR, Shoptaw S, Fudala PJ, Gorgon L, Montoya I, Collins J, McSherry F, Li SH, Chiang N, Alathari H, Watson D, Liberto J, Beresford T, Stock C, Wallace C, Gruber V, Elkashef A. Multi-center trial of baclofen for abstinence initiation in severe cocaine-dependent individuals. Drug Alcohol Depend. 2009 May 2; [Epub ahead of print]

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

160

Completion Date

Not Provided

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject must have DSM-IV diagnosis of cocaine dependence.
Subject must be seeking treatment for cocaine dependence.
Be be able to verbalize understanding of consent form, provide written consent and verbalize willingness to complete study procedures.

Exclusion Criteria:

Please contact site for more information.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00082485

Other Study ID Numbers ^ICMJE

NIDA-CSP-1021-1

Has Data Monitoring Committee

Not Provided

Responsible Party

Liza Gorgon, National Institute on Drug Abuse

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Liza Gorgon, M.A.

VA Maryland Health Care System

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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