Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Reinforcing Effects
研究概览
简要总结
The research proposed in this application will determine the initial efficacy, safety and tolerability of a novel drug combination, oxazepam (Serax®) and naltrexone (Revia®), as a pharmacotherapy for methamphetamine (Desoxyn®) dependence. A rigorous, inpatient human laboratory study will be conducted. The proposed study is innovative and important because it will provide the impetus for the conduct of double blind, placebo-controlled trials to further demonstrate the efficacy of combined oxazepam and naltrexone for managing methamphetamine dependence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lifetime methamphetamine use
排除标准
- •Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
- •Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
- •History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
- •Females not currently using effective birth control
- •Contraindications to methamphetamine (Desoxyn®), oxazepam (Serax®) or naltrexone (Revia®)
研究组 & 干预措施
Arm 1
Subjects will be maintained on oral placebo.
干预措施: Methamphetamine (Desoxyn®) (Drug)
Arm 2
Subjects will be maintained on oral oxazepam (Serax®).
干预措施: Methamphetamine (Desoxyn®) (Drug)
Arm 3
Subjects will be maintained on oral naltrexone (Revia®).
干预措施: Methamphetamine (Desoxyn®) (Drug)
Arm 4
Subjects will be maintained on oral naltrexone (Revia®) and oral oxazepam (Serax®).
干预措施: Methamphetamine (Desoxyn®) (Drug)
结局指标
主要结局
Reinforcing Effects
时间窗: After at least four days of placebo, oxazepam (Serax®), naltrexone (Revia®) or oxazepam and naltrexone maintenance
The reinforcing effects of methamphetamine will be determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo, oxazepam (Serax®), naltrexone (Revia®), and oxazepam and naltrexone combined.
次要结局
- Subjective Effects(12 sessions over approximately 4 week inpatient admissions)
- Physiological and Side Effects(Daily over approximately 4 week inpatient admissions)
研究者
Craig Rush
Professor
University of Kentucky