Doxazosin, An Alpha-1 Adrenergic Antagonist, for Cocaine Dependence: Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Cocaine Negative Urines
研究概览
简要总结
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.
详细描述
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:
- 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)
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets DSM-IV diagnosis criteria for cocaine dependence, as determined by self-reported use of cocaine at least once weekly for at least 1 month prior to study entry; a positive urine test for cocaine; and a score greater than 3 on the Severity of Dependence Scale
- •If female, willing to use contraception throughout the study
排除标准
- •Meets DSM-IV diagnosis criteria for dependence on any drugs other than cocaine, or tobacco
- •Current major psychiatric illness, including schizophrenia, bipolar disorder, or other psychotic disorder
- •Current suicidal or homicidal ideation
- •Current use of a prescribed psychotropic medication that cannot be discontinued
- •History of or current major medical illness, including major heart, kidney, endocrine, or liver disorder; abnormal liver function (SGOT or SGPT levels three times greater than normal); or high blood pressure or low blood pressure
- •High risk factor for heart disease, seizure disorders, or any illness for which disulfiram or methadone treatment would be inadvisable
- •Currently taking metronidazole or clotrimazole
- •Pregnant or breastfeeding
研究组 & 干预措施
Doxazosin
Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows:
- 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)
- 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.
干预措施: Doxazosin (Drug)
placebo
A sugar pill to mimic the experiment drug, doxazosin, will be administered in the same manner as the experimental drug through the study duration.
干预措施: Placebo (Other)
结局指标
主要结局
Cocaine Negative Urines
时间窗: throughout the study - up to 17 weeks
cocaine urine toxicology samples were obtained thrice weekly and tested for the presence of the cocaine metabolite, benzoylecgonine
次要结局
- Adverse Events(throughout study - upto 17 weeks)
- Weeks of Abstinence(throughout the study - up to 17 weeks)
- # of Participants That Completed the Study(throughout the study - up to 17 weeks)
研究者
Thomas R. Kosten, MD
Professor
Baylor College of Medicine