Pharmacogenetics of Doxazosin for Cocaine Dependence
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|ClinicalTrials.gov Identifier: NCT01145183|
Recruitment Status : Completed
First Posted : June 16, 2010
Results First Posted : July 22, 2019
Last Update Posted : July 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependence||Drug: Doxazosin Drug: Placebo||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||H-26605: Pharmacogenetics of Doxazosin for Cocaine Dependence|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
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)
- Percentage of Cocaine Positive Urine Toxicology [ Time Frame: 2 weeks blocks throughout study ]Cocaine positive urines
- Adverse Events [ Time Frame: Pre- and post study medication ]Adverse effects were closely monitored during each clinic visit throughout this trial. Vital signs including blood pressure (both pre-medication and post-medication) were measured and documented as were concomitant medications.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145183
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Thomas R. Kosten, MD||Baylor College of Medicine|