NCT01843205已完成1 期
Buspirone as a Candidate Medication for Methamphetamine Abuse
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Methamphetamine Doses Self-Administered
研究概览
简要总结
Methamphetamine use disorders are an unrelenting public health concern. Intensive research efforts have yielded behavioral interventions that reduce methamphetamine use, however, these interventions are not universally effective and treatment effects diminish over time. Development of a pharmacotherapy that enhances the efficacy of these interventions is a priority for the National Institute on Drug Abuse. This study proposes to determine the impact of buspirone maintenance on self-administration of methamphetamine. These preliminary data will be used to support further research developing buspirone as a pharmacotherapy for methamphetamine use disorders. The investigators hypothesize that buspirone will attenuate the reinforcing effects of methamphetamine.
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 or buspirone
研究组 & 干预措施
Placebo
Placebo Comparator
Subjects will be maintained on placebo.
干预措施: Methamphetamine (Drug)
Placebo
Placebo Comparator
Subjects will be maintained on placebo.
干预措施: Placebo (Drug)
Buspirone
Experimental
Subjects will be maintained on buspirone.
干预措施: Methamphetamine (Drug)
Buspirone
Experimental
Subjects will be maintained on buspirone.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Methamphetamine Doses Self-Administered
时间窗: One test per methamphetamine dose level per intervention for each participant over his/her approximate 25 day inpatient admission
The reinforcing effects of methamphetamine will be determined during placebo and buspirone treatment using a modified progressive ratio procedure in which subjects are offered the opportunity to earn previously sampled doses of methamphetamine. Each ratio completed on the task will earn 1/10th of the sampled dose.
次要结局
- Peak Score on Sedative Subscale of the Adjective Rating Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Score on Stimulant Subscale of the Adjective Rating Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Any Effect" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Bad Effects" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Euphoric" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Good Effects" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "High" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Like Drug" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Nauseous" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Willing to Pay For" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Performance Impaired" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Performance Improved" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Restless" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Rush" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Stimulated" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Willing to Take Again" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Diastolic Blood Pressure(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Systolic Blood Pressure(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Heart Rate(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
- Peak Temperature(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
研究者
Craig Rush
Professor
University of Kentucky
研究点 (1)
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