NCT01651377

Pramipexole as a Treatment for Cocaine Dependence

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purposes of this study are as follows: 1. To assess the cardiovascular and subjective effects of cocaine during treatment with pramipexole and placebo. 2. To assess the reinforcing effects of cocaine, measured using choice procedures, during treatment with pramipexole and placebo.

Detailed description

In this protocol we propose to assess the impact of treatment with higher doses of the potent D2/3 agonist pramipexole, using the extended release preparation that has been shown to produce continuous DA receptor stimulation. Pramipexole is a non-ergot DA 3 receptor-preferring agonist. In contrast to pergolide, bromocriptine and cabergoline, it does not stimulate 5-HT2B receptors and therefore does not cause cardiac valvulopathy. It can therefore be safely used chronically at higher doses, whereas pergolide has been withdrawn from the market for causing cardiac valvulopathy.

Conditions

• Cocaine Addiction
• Cocaine Abuse
• Cocaine Dependence
• Substance Abuse

Interventions

Type	Name	Description
DRUG	Pramipexole	Participants will receive pramipexole ER 0.375, .075, 1.5, 2.25, and 3mg/d in an ascending-dose pattern.
DRUG	Placebo	Participants will receive matching placebo pills. The placebo group is included to maintain the blind, rather than as a comparison group.

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-07-27
• Last updated: 2014-07-22

Locations

1 site across 1 country: United States