Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pain Tolerance
研究概览
简要总结
The following study is designed to determine the analgesic efficacy of smoked marijuana (0, 1.98, and 3.56% THC) and oral THC (0, 10, and 20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for clinical use of analgesics. Oral THC (dronabinol) is known to have a slower onset and longer duration of action compared with smoked marijuana. Therefore, the analgesic effects of oral THC is expected to peak later and last longer than effects produced by smoked marijuana.
详细描述
Laboratory animal studies have demonstrated the analgesic effects of drugs which act on the cannabinoid system, however, these effects have et to be clearly elucidated in humans. To better understand the potential clinical application of cannabinoids for pain management, the following study is designed to determine the analgesic efficacy of smoked marijuana (3.56% THC) and oral THC (20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for clinical use of analgesics. Non-treatment seeking marijuana smokers will be recruited for a five-session study during which the analgesic, subjective, and physiologic effects of cannabinoids will be evaluated. Determining the efficacy of cannabinoids in an experimental model of pain will provide important endpoints (i.e., dose, route of administration, time course) or this effect to further investigate the potential role for clinical use of smoked marijuana and/or oral THC as analgesics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Placebo-controlled, double-blind
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adults between the ages of 21-45
- •Current marijuana use
- •Able to perform study procedures
- •Women practicing an effective form of birth control
排除标准
- •Female subjects who are currently pregnant or breastfeeding
- •Current,repeated illicit drug use other than marijuana
- •Presence of significant medical illness
- •History of heart disease
- •Request for drug treatment
- •Current parole or probation
- •Recent history of significant violent behavior
研究组 & 干预措施
Placebo + inactive marijuana (0% THC)
Participants received placebo capsules and smoked inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.
干预措施: Placebo capsules (Drug)
Placebo + inactive marijuana (0% THC)
Participants received placebo capsules and smoked inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.
干预措施: Inactive marijuana (0% THC) (Drug)
Dronabinol 10 mg + Marijuana (0% THC)
Participants received low dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.
干预措施: Inactive marijuana (0% THC) (Drug)
Dronabinol 10 mg + Marijuana (0% THC)
Participants received low dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.
干预措施: Low dose Dronabinol (Drug)
Dronabinol 20 mg + Marijuana (0% THC)
Participants received High dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.
干预措施: Inactive marijuana (0% THC) (Drug)
Dronabinol 20 mg + Marijuana (0% THC)
Participants received High dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.
干预措施: High dose Dronabinol (Drug)
Placebo + Marijuana (1.98% THC)
Participants received placebo + low THC marijuana (1.98% THC) on 1 of 5 outpatient sessions in randomized order.
干预措施: Placebo capsules (Drug)
Placebo + Marijuana (1.98% THC)
Participants received placebo + low THC marijuana (1.98% THC) on 1 of 5 outpatient sessions in randomized order.
干预措施: Low THC marijuana (Drug)
Placebo + Marijuana (3.56% THC)
Participants received placebo + smoked high THC marijuana (3.56 % THC) on 1 of 5 outpatient sessions in randomized order.
干预措施: Placebo capsules (Drug)
Placebo + Marijuana (3.56% THC)
Participants received placebo + smoked high THC marijuana (3.56 % THC) on 1 of 5 outpatient sessions in randomized order.
干预措施: High THC marijuana (Drug)
结局指标
主要结局
Pain Tolerance
时间窗: Within each session lasting approximately 5 minutes, for a total of five sessions
Change in pain tolerance from baseline (in seconds) as a function of drug condition. The cold pressor test was administered during each session to examine changes in pain threshold (how many seconds it takes for a participant to begin feeling pain after cold water immersion).
次要结局
未报告次要终点