Phase 1, Pilot Study to Examine the Cardiovascular Effects of Smoked Marijuana, Interactions With Oral Dronabinol, and Effects of Dronabinol on Withdrawal in Marijuana Dependent Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects.
研究概览
简要总结
This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant drug interactions before conducting outpatient studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be between 18 and 45 years of age
- •Must be in good general health and who meet DSM-IV diagnostic criteria for marijuana dependence
- •Must be seeking treatment at time of study entry
- •Must be able to understand and provide written informed consent
- •Must provide 1 marijuana positive urine specimen (> 50 ng/mL) within the 28-day screening period
- •If female and of child bearing potential, agrees to use birth control.
- •Please contact site for more information
排除标准
- 未提供
研究组 & 干预措施
Dronabinol
干预措施: Dronabinol (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects.
时间窗: Day 9 and 10
Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects.
次要结局
未报告次要终点
研究者
NIDA Project Officer
National Institute on Drug Abuse (NIDA)