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Clinical Trial 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.


Clinical Trial 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 It can therefore be safely used chronically at higher doses, whereas pergolide has been withdrawn from the market for causing cardiac valvulopathy. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


NCT number NCT01651377
Study type Interventional
Source Baylor College of Medicine
Contact
Status Completed
Phase Phase 1
Start date October 2011
Completion date December 2012

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