A Pilot Study of Cabergoline for the Treatment of Cocaine Dependence
|ClinicalTrials.gov Identifier: NCT01651364|
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : July 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependence Cocaine Abuse Cocaine Addiction Substance Abuse||Drug: Placebo Drug: Cabergoline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Pilot Study of Cabergoline for the Treatment of Cocaine Dependence|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
|Placebo Comparator: Placebo||
Enrolled volunteers will be randomized on Day 8 to receive placebo (n=2) or study medication (n=8). Placebo serves only to maintain the blind and is not a comparator.
Other Name: Sugar pill
|Active Comparator: Cabergoline||
Enrolled volunteers that receive study medication (n=8) will receive cabergoline 0.25 mg twice weekly.
- The effects of treatment with cabergoline and cocaine on cardiovascular measuresBefore 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 cabergoline 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 treatment with cabergoline and cocaine on cocaine-induced craving and subjective effectsThe ability of cabergoline, 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): NCT01651364
|United States, Texas|
|Michael E. DeBakey VA Medical Center|
|Houston, Texas, United States, 77030|