Clinical trial NCT00880997
Conditions: Cocaine Dependence
Keywords: Cocaine Dependence Substance Related Disorders
Sponsor: Baylor College of Medicine
Start date: 2009-09-01; Completion date: 2011-12-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Doxazosin, an alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. This study will evaluate the effectiveness of doxazosin in preventing drug relapse among cocaine dependent participants.

Detailed description:
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.

Medication induction will occur at a rate of 2mg/week until 8mg/day target dose is achieved as follows:

1. Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants will be stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group)
2. Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants will be stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group)

Both groups will be tapered off doxazosin or placebo over study weeks 14-17.

Arms: arm 1: Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows:

1. Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group)
2. Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group)

Both groups were tapered off doxazosin or placebo over study weeks 14-17. arm 2: A sugar pill to mimic the experiment drug, doxazosin, will be administered in the same manner as the experimental drug through the study duration.
Interventions: intervention 1: Doxazosin intervention 2: Placebo
Intervention descriptions: intervention 1: Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows:

1. Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group)
2. Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group)

Both doxazosin groups will be tapered off doxazosin or placebo over study weeks 14-17. intervention 2: Participants will be administered a sugar pill to mimic the doxazosin active medication with administration being the same as the active medication.

Protocol documents: