A Randomized Placebo-controlled Study of Baclofen ER on Brain and Behavioral Outcomes in Cocaine Dependence
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Urines positive for benzoylecgonine (BE), (a metabolite of cocaine)
研究概览
简要总结
This is a Phase II, randomized, double-blind, placebo-controlled study that will examine the efficacy of extended-release baclofen (Baclofen ER) for the treatment of cocaine dependence. The primary study outcome will be urines positive for benzoylecgonine (BE), a metabolite of cocaine, submitted during outpatient treatment (12-week) and follow-up (12-week). To examine brain mechanisms of relapse/recovery, participants will complete fMRI sessions before, during, and after treatment. Brain responses to specific probes of reward and inhibition will be used as biomarkers predicting drug use during and after the 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physically healthy cocaine-dependent (based on DSM-IV- TR criteria) male or female aged 18-60 yrs, voluntarily seeking treatment for cocaine dependence.
- •Females must be non-pregnant, non- lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of child bearing potential, but practicing a medically acceptable method of birth control. Examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine device (IUD), oral contraceptives, a levonorgestrel implant, intrauterine progesterone contraceptive system, medroxyprogesterone acetate contraceptive injection, and abstinence.
- •Reading level at or above eighth grade.
- •Participants provide voluntary informed consent.
- •Smoking is primary route of cocaine administration.
- •Available for an inpatient stay.
排除标准
- •Participation in clinical trial and receipt of investigational drug(s) during previous 60 days, except as explicitly approved by the Principal Investigator.
- •Clinically significant cardiovascular, hematologic, hepatic, renal, neurological or endocrinological abnormalities.
- •History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI.
- •Presence of magnetically active prosthetics, plates, pins, broken needles, permanent retainer, bullets, etc. in patient's body (unless a radiologist confirms that its presence is unproblematic). An x-ray may be obtained to determine eligibility.
- •Claustrophobia or other medical condition that disables the participant from lying in the MRI for approximately 60 minutes.
- •Current or prior gambling problems (assessed by participants self-report)
- •Non-removable skin patches
- •Have received medication that could interact adversely with baclofen, including muscle relaxants (including tricyclic antidepressants), antiseizure medication, CNS depressants (tranquilizers, sleeping pills), MAO inhibitors), within the time of administration of study agent based on the study physician's guidance (e.g. 5 half lives)
- •Have known or suspected hypersensitivity to baclofen.
- •Be taking baclofen for any reason currently or during the past year.
研究组 & 干预措施
Baclofen ER versus Placebo
Baclofen ER versus Placebo (sugar pill)
干预措施: Baclofen ER (Drug)
Placebo versus Baclofen ER
Participants will receive either placebo (sugar pill) or Baclofen ER
干预措施: Placebo (Drug)
结局指标
主要结局
Urines positive for benzoylecgonine (BE), (a metabolite of cocaine)
时间窗: up to 24 weeks
The primary clinical outcome is number of cocaine-use days (assessed by urines positive for benzoylecgonine (BE), a metabolite of cocaine) during the outpatient treatment and follow-up phases of the study.
次要结局
未报告次要终点