Baclofen for the Treatment of Cocaine Dependence - 1

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Cocaine-Related Disorders

Treatments: Other: Placebo; Drug: Baclofen

Study type: Interventional

Funder types: NIH

Identifiers

NCT00082485

NIDA-CSP-1021-1

Details and patient eligibility

About

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

Full description

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

Enrollment: 160 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Baclofen

2

Placebo Comparator group

Treatment:

Other: Placebo