A Study of Cabergoline for the Treatment of Cocaine Dependence - 1

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Substance-Related Disorders; Cocaine-Related Disorders

Treatments: Drug: Cabergoline; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00033111

NIDA-CTO-0007-1

Details and patient eligibility

About

The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence

Full description

To assess the efficacy and safety of cabergoline in reducing cocaine use in subjects with cocaine dependence. This is a DB, placebo-controlled, parallel group design study where subjects will receive either .5mg cabergoline or placebo for 12 weeks with a 4 week follow-up.

Enrollment: 140 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Must have a DSM-4 criteria for cocaine dependence; be seeking treatment for cocaine dependence; have the ability to understand and provide written informed consent; females of child-bearing potential using proper method of birth control.

Exclusion criteria

Additional criteria available during screening at the site.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

Cabergoline

Active Comparator group

Description:

Subjects received one tablet of 0.5 mg of cabergoline tablet per week for 12 weeks.

Treatment:

Drug: Cabergoline

Placebo

Placebo Comparator group

Description:

Subjects received one tablet of 0.5 mg of cabergoline matched placebo tablet per week for 12 weeks.

Treatment:

Drug: Placebo