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

Cocaine-Related Disorders Clinical Trial

Official title:

Rapid Evaluation of Cocaine Pharmacotherapies (Baclofen)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000303
• Other study ID #: NIDA-09260-6
• Secondary ID: P50DA009260P50-0
• Status: Completed
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: July 7, 2016
• Start date: October 1997

Study information

• Verified date: July 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: May 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Baclofen

Locations

Country	Name	City	State
United States	Friends Research Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention
Primary	Cocaine use
Primary	Cocaine craving
Primary	Psychosocial progress