Baclofen for the Treatment of Cocaine Dependence - 1

Multi-Center Trial of Baclofen for the Treatment of Cocaine Dependence

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00082485

Enrollment

160

Registered

2004-05-12

Start date

2004-06-30

Completion date

Unknown

Last updated

2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine-Related Disorders

Keywords

Cocaine Dependence

Brief summary

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

Detailed description

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

Interventions

DRUGBaclofen

Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Effects of medication on cocaine craving	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026