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Baclofen for the Treatment of Cocaine Dependence - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00082485
Recruitment Status : Completed
First Posted : May 12, 2004
Last Update Posted : January 12, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

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

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Baclofen Other: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center Trial of Baclofen for the Treatment of Cocaine Dependence
Study Start Date : June 2004
Actual Primary Completion Date : July 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1 Drug: Baclofen
Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)

Placebo Comparator: 2 Other: Placebo

Primary Outcome Measures :
  1. Effects of medication on cocaine craving

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00082485

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United States, California
San Francisco General Hosptial
San Francisco, California, United States, 94110
Torrance Site
Torrance, California, United States, 90502
United States, Colorado
Denver VA Medical Center
Denver, Colorado, United States, 80220
United States, Maryland
VA Maryland Healthcare System
Baltimore, Maryland, United States, 21201
United States, Pennsylvania
U of Penn School of Medicine
Philadelphia, Pennsylvania, United States, 19104 6178
United States, Texas
South TX VA Health Care System
San Antonio, Texas, United States, 78284 4404
United States, Utah
Salt Lake City VA Medical Center
Salt Lake City, Utah, United States, 84148
United States, Virginia
Institute of Resch & Educ Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042 3300
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Liza Gorgon, M.A. VA Maryland Health Care System
Publications of Results:
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Responsible Party: Liza Gorgon, National Institute on Drug Abuse Identifier: NCT00082485    
Obsolete Identifiers: NCT00431938
Other Study ID Numbers: NIDA-CSP-1021-1
First Posted: May 12, 2004    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: August 2016
Keywords provided by National Institute on Drug Abuse (NIDA):
Cocaine Dependence
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action