The Efficacy of Doxazosin for Cocaine Users
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Doxazosin, An Alpha-1 Adrenergic Antagonist, for Cocaine Dependence: Pilot Study|
- Self reports of cocaine and other drug use and cravings [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- The urine drug screen results [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- Doxazosin will be well tolerated without significant side effects as we increased to our target dose of 8 mg Doxazosin daily [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
The starting dose will be 1 mg once daily at week 1 of the overall 17 week study, then 2 mg at week 2, with 1mg/week induction rate for 8 weeks. The target dose of 8 mg daily will probably not be attained by some patients over a 8 week induction period. We will try to increase their dose up to a minimum of 4 mg and optimum of 8 mg daily as daily dosing.
The target dose of 8 mg will probably not be attained by some patients over a 8 week induction period (starting at week 1 of the overall 17 week study). We will try to increase the subjects' dose up to a minimum of 4 mg and optimum of 8 mg daily as once daily dosing. The starting dose will be 1 mg once daily at week 1, then 2 mg once daily at week 2, with 1mg/week induction rate for 8 weeks. They will be maintained on 4mg-8mg daily dosing until week 13. The subjects will be undergo the discontinuation from the study medication during weeks 14 -17.
Other Name: Cardura (Doxazosin Mesylate)
|Placebo Comparator: placebo||
Placebo daily dosing
Other Name: sugarpills ( Capsules)
The NE system, especially the alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. The results of this study will provide medical safety data on the duration of the induction schedule that will be optimal for attaining our target dose of 8 mg doxazosin daily and will guide future pharmacotherapy trials using Doxazosin or related alpha 1 receptor antagonists for cocaine addiction.
This 17-week double-blind, placebo controlled clinical trial includes a 13 week medication trial (weeks 1-13) and up to 4 week washout period(weeks 14-17). Qualifying subjects will be randomized to receive Doxazosin 8 mg/day, or placebo during the study participation.
Subjects will be receiving 1 mg study medication/placebo capsules at week 1, with 1mg/week induction rate for 8 weeks, according to their randomized assignments, and are maintained on these agents through week 13. At the end of the study (weeks 14-17), participants will undergo discontinuation from active/placebo medication over a 4-week period. Subjects who wish to be transferred to an appropriate treatment program or treatment-research program will be helped with referral during the 4 week period (weeks 14-17).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880997
|United States, Texas|
|Baylor College of Medicine - Michael E. DeBakey VA Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Thomas R Kosten, MD||Baylor College of Medicine|