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

Primary Purpose

Cocaine-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Baclofen
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring Cocaine dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Friends Research Institute

Outcomes

Primary Outcome Measures

Retention
Cocaine use
Cocaine craving
Psychosocial progress

Secondary Outcome Measures

Full Information

First Posted
September 20, 1999
Last Updated
July 7, 2016
Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000303
Brief Title
Rapid Evaluation of Baclofen for Treatment of Cocaine Abuse/Dependence - 6
Official Title
Rapid Evaluation of Cocaine Pharmacotherapies (Baclofen)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 1997 (undefined)
Primary Completion Date
May 1999 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
Cocaine dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
0 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Baclofen
Primary Outcome Measure Information:
Title
Retention
Title
Cocaine use
Title
Cocaine craving
Title
Psychosocial progress

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Ling, M.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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