The Effect of Prescription Medications in Marijuana Users
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Peak Effect of Marijuana Withdrawal
研究概览
简要总结
A subset of heavy marijuana users have trouble quitting marijuana use and the number of those seeking treatment for problems related to marijuana is increasing. The purpose of this research study is to investigate whether dronabinol can reduce withdrawal effects associated with stopping marijuana use, if dronabinol can reduce the rewarding effects of smoked marijuana, and whether there are any cognitive performance deficits associated with dronabinol doses that produce such effects.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Dronbinol doses were double blind and placebo controlled
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •current use of marijuana
- •able to give informed consent
排除标准
- •dependence on drug other than marijuana
- •pregnant, breast feeding, or planning to become pregnant within the next 3 months
- •currently seeking treatment for cannabis-related problems or otherwise trying to reduce use
- •use of cannabis under the guidance of a physician for a medical disorder
- •unstable or uncontrolled cardiovascular disease (e.g., hypertension, angina)
- •allergy to study medication
研究组 & 干预措施
0, 30, 60, and 120mg dronabinol
0, 30, 60, and 120mf dronabinol was administered in a randomized within-subjects crossover study to compare the medication dose effects of cannabis withdrawal, cognitive performance, and response to acute cannabis dosing
干预措施: Dronabinol 30mg/day (Drug)
0, 30, 60, and 120mg dronabinol
0, 30, 60, and 120mf dronabinol was administered in a randomized within-subjects crossover study to compare the medication dose effects of cannabis withdrawal, cognitive performance, and response to acute cannabis dosing
干预措施: Dronabinol 60mg/day (Drug)
0, 30, 60, and 120mg dronabinol
0, 30, 60, and 120mf dronabinol was administered in a randomized within-subjects crossover study to compare the medication dose effects of cannabis withdrawal, cognitive performance, and response to acute cannabis dosing
干预措施: Dronabinol 120mg/day (Drug)
0, 30, 60, and 120mg dronabinol
0, 30, 60, and 120mf dronabinol was administered in a randomized within-subjects crossover study to compare the medication dose effects of cannabis withdrawal, cognitive performance, and response to acute cannabis dosing
干预措施: Placebo (Drug)
结局指标
主要结局
Peak Effect of Marijuana Withdrawal
时间窗: Day 5 of the Dronabinol abstinence period
Total withdrawal based on a composite score of the Marijuana Withdrawal Checklist (range 0-32; higher scores indicate greater withdrawal).
Subjective "Drug Effect" After Smoked Marijuana
时间窗: Day 5 of the Dronabinol abstinence period
Subjective drug effects on a 100mm point Visual Analog Scale reported following acute cannabis dose administration during dronabinol maintenance, scale ranging 0-100, with 0 being no effect and 100 being maximum effect
次要结局
- Heart Rate(Assessed on Day 5 of dronabinol maintenance)