NCT00000303

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

1.6 years

First QC Date

September 20, 1999

Last Update Submit

July 7, 2016

Conditions

Cocaine-Related Disorders

Keywords

Cocaine dependence

Outcome Measures

Primary Outcomes (4)

  • Retention

  • Cocaine use

  • Cocaine craving

  • Psychosocial progress

Interventions

BaclofenDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friends Research Institute

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Walter Ling, M.D.

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

October 1, 1997

Primary Completion

May 1, 1999

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations

US(1)