Pramipexole as a Treatment for Cocaine Dependence
|ClinicalTrials.gov Identifier: NCT01651377|
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : July 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Addiction Cocaine Abuse Cocaine Dependence Substance Abuse||Drug: Pramipexole Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pramipexole as a Treatment for Cocaine Dependence|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
|Placebo Comparator: Placebo||
Participants will receive matching placebo pills. The placebo group is included to maintain the blind, rather than as a comparison group.
Other Name: Sugar pill
|Active Comparator: Pramipexole||
Participants will receive pramipexole ER 0.375, .075, 1.5, 2.25, and 3mg/d in an ascending-dose pattern.
Other Name: Mirapex
- The effects of pramipexole and cocaine on cardiovascular measures [ Time Frame: 16 days ]Before and after each cocaine infusion, physiologic responses will be closely monitored using repeated HR, BP, and ECG readings. To evaluate safety, a DSMB will meet annually and following any serious AE to examine data as well as any new published information on pramipexole relevant to the project. The number of AEs (including arrhythmias and ECG changes), changes in BP and HR, and changes in mood and psychiatric symptoms (using the BSI, BDI, POMS, and BPRS) will also be assessed throughout the study.
- The effects of pramipexole and cocaine on subjective measures [ Time Frame: 16 days ]The ability of pramipexole, as compared to placebo, to reduce cocaine-induced craving and to reduce reinforcing effects produced by cocaine will be measured by: 1. VAS, Adjective Scales, and MCQ; 2. Choices for cocaine vs. money in the self-administration assay.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651377
|United States, Texas|
|Michael E. DeBakey VA Medical Center|
|Houston, Texas, United States, 77030|