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
  Purpose

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


Condition Intervention Phase
Cocaine-Related Disorders
Drug: Baclofen
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center Trial of Baclofen for the Treatment of Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Effects of medication on cocaine craving

Enrollment: 160
Study Start Date: June 2004
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082485

Locations
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
Investigators
Principal Investigator: Liza Gorgon, M.A. VA Maryland Health Care System
  More Information

Publications:
Responsible Party: Liza Gorgon, National Institute on Drug Abuse
ClinicalTrials.gov Identifier: NCT00082485     History of Changes
Obsolete Identifiers: NCT00431938
Other Study ID Numbers: NIDA-CSP-1021-1
Study First Received: May 11, 2004
Last Updated: May 14, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Baclofen
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014