A Randomized Controlled Evaluation of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence (BRAC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 6
- 主要终点
- Maximum Days of Continuous Cocaine Abstinence
研究概览
简要总结
The purpose of this study is to evaluate whether or not buspirone is effective in preventing relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to enter outpatient treatment upon inpatient/residential discharge.
详细描述
The primary objective is to evaluate the efficacy of buspirone, relative to placebo, in preventing relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to enter outpatient treatment upon inpatient/residential discharge. Secondary objectives include evaluating the impact of buspirone, relative to placebo, on other drug-abuse outcomes and on factors that may mediate buspirone's efficacy as a relapse-prevention treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be 18 years of age or older
- •be able to understand the study, and having understood, provide written informed consent in English
- •meet DSM-IV-TR diagnostic criteria for current (within the last 12 months) dependence for cocaine, must self-report having used crack cocaine a minimum of four times in the 28 days prior to inpatient/residential admission, and must report that their typical pattern of use is at least once a week
- •have a willingness to comply with all study procedures and medication instructions
- •be enrolled in an inpatient/residential program at a participating CTP, scheduled to be in inpatient/residential treatment for 12-19 days when randomized, and planning to enroll in local outpatient treatment through the end of the active treatment phase (i.e., study week 15)
- •if female and of child bearing potential, agree to use one of the following methods of birth control:
- •oral contraceptives
- •contraceptive patch
- •barrier (diaphragm or condom)
- •intrauterine contraceptive system
- •levonorgestrel implant
- •medroxyprogesterone acetate contraceptive injection
- •complete abstinence from sexual intercourse
- •hormonal vaginal contraceptive ring
排除标准
- •meet DSM-IV-TR diagnostic criteria for current (within the last 12 months) opioid dependence
- •have a medical or psychiatric condition that, in the judgment of the study physician, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to:
- •AIDS according to the current CDC criteria for AIDS
- •liver function tests greater than 3X upper limit of normal
- •serum creatinine greater than 2 mg/dL
- •have a psychiatric disorder requiring continued treatment with a psychotropic medication
- •have a known or suspected hypersensitivity to buspirone
- •be pregnant or breastfeeding
- •have used any of the following medications within 14 days of randomization: monoamine oxidase (MAO) inhibitors such as phenelzine (Nardil), selegiline (Eldepryl), isocarboxazid (Marplan), or tranylcypromine (Parnate)
- •be taking any medications which, in the judgment of the study physician, may produce interactions with buspirone that are sufficiently dangerous so as to exclude the patient from participating in the study. Alternatively, the study physician, in consultation with the patient and his or her physician, may elect to withdraw the patient from the problem medications before randomization. Some of the possible interactions are discussed in section 8.
- •be anyone who, in the judgment of the investigator, would not be expected to complete the study protocol (e.g., due to relocation from the clinic area, probable incarceration, etc.)
- •be a significant suicidal/homicidal risk
研究组 & 干预措施
Buspirone plus TAU
Buspirone titrated to 60 mg/day for the 15-week active study
干预措施: Buspirone (Drug)
Placebo plus TAU
Placebo taken daily for the 15-week active study
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum Days of Continuous Cocaine Abstinence
时间窗: study week 16
The primary outcome measure selected for the present two-stage protocol is the maximum days of continuous cocaine abstinence during study weeks 4-15. The Timeline Follow-back (TLFB) procedure (Sobell and Sobell, 1992; Fals-Stewart, 2000) will be used to assess the participants' self-reported use of substances for each day of the study. A rapid UDS system that screens for drugs of abuse will be used to analyze the urine samples.
次要结局
- Cocaine-use Days(study week 16)
研究者
Theresa Winhusen
Associate Professor, Department of Psychiatry and Behavioral Neuroscience; CinARC Director
University of Cincinnati