Pharmacogenetics of Doxazosin for Cocaine Dependence
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||H-26605: Pharmacogenetics of Doxazosin for Cocaine Dependence|
- The urine drug screen results and self reports of cocaine and other drug use and cravings [ Time Frame: through out study ] [ Designated as safety issue: No ]The urine toxicology tests and scales to report drug use will be performed through out study.
- Adverse events reports [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]Doxazosin will be well tolerated without significant side effects as we increased to our target dose of 8 mg Doxazosin daily
|Study Start Date:||March 2010|
|Study Completion Date:||September 2015|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Doxazosin is a long-acting and selective alpha 1-NE blocker, which inhibits the binding of norepinephrine to alpha receptors in the autonomic nervous system.
Doxazosin is initiated at 4 mg/wk, and titrated up to a maximum of 8 mg/day over approximately 2 weeks. Participants will be maintained on 6mg-8mg daily dosing until week 13. The subjects will undergo the discontinuation from the study medication during weeks 14 -15.
Other Name: Cardura (Doxazosin Mesylate)
Placebo Comparator: Placebo
Matched placebo daily dosing.
Matched 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 16-week double-blind, placebo controlled clinical trial will provide treatment for 100 cocaine-dependent patients and includes a 13 week medication trial (weeks 1-13) and up to 2 week washout period(weeks 14-15). 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 4mg/week induction rate for weeks, according to their randomized assignments, and are maintained on these agents through week 13. At the end of the study (weeks 14-15), participants will undergo discontinuation from active/placebo medication over a 2-week period. Subjects who wish to be transferred to an appropriate treatment program or treatment-research program will be helped with referral during the 2 week period (weeks 14-15).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145183
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Thomas R. Kosten, MD||Baylor College of Medicine|