Rapid Evaluation of Baclofen for Treatment of Cocaine Abuse/Dependence - 6

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT00000303
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 0
• Location: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to empirically test a series of medications to: 1) determine each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective dose range for each medication. In this study, baclofen is tested.

Condition or Disease	Intervention/Treatment	Phase
Cocaine-Related Disorders	Drug: Baclofen	Phase 2

Detailed Description

16-week participation plus a 2 week lead in period. Participants are assigned randomly to placebo or baclofen. Participant attend group meetings 3 x/week.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Rapid Evaluation of Cocaine Pharmacotherapies (Baclofen)
• Study Start Date: Oct 1, 1997
• Actual Primary Completion Date: May 1, 1999

Outcome Measures

Primary Outcome Measures

1. Retention []

2. Cocaine use []

3. Cocaine craving []

4. Psychosocial progress []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

M/F ages 18-65. cocaine dependence according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy, history of seizures, pregnant and/or nursing women, dependence on ethanol (ETOH) or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Friends Research Institute	Los Angeles	California	United States	90025

Sponsors and Collaborators

• University of California, Los Angeles
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Walter Ling, M.D., Friends Research Institute, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT00000303
• Other Study ID Numbers: NIDA-09260-6; P50DA009260; P50-09260-6
• First Posted: Sep 21, 1999
• Last Update Posted: Jul 11, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by University of California, Los Angeles: Cocaine dependence
• Additional relevant MeSH terms: Cocaine-Related Disorders; Baclofen

Study Results

No Results Posted as of Jul 11, 2016