Cannabis and Opioid Use Disorder, Study 2
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Opioid withdrawal severity
研究概览
简要总结
This inpatient study enrolls healthy individuals who have opioid use disorder. Participants live at the University of Kentucky Hospital for approx. 6 weeks. During this time, we will examine how repeated doses of oral cannabis and acute doses of oral and inhaled cannabis 1) modify the intensity and time course of opioid withdrawal, 2) modify the effects of intranasal opioid administration and 3) impact the safety of opioid administration.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with moderate to severe opioid use disorder
排除标准
- •Individuals who do not use opioids or do not experience opioid withdrawal when they stop using opioids
研究组 & 干预措施
Oral cannabis (active)
Participants will receive active oral cannabis
干预措施: Intranasal Opioid (Drug)
Oral cannabis (placebo)
Participants will receive placebo oral cannnabis
干预措施: Inhaled Cannabis (Drug)
Oral cannabis (placebo)
Participants will receive placebo oral cannnabis
干预措施: Intranasal Opioid (Drug)
Oral cannabis (active)
Participants will receive active oral cannabis
干预措施: Inhaled Cannabis (Drug)
结局指标
主要结局
Opioid withdrawal severity
时间窗: This outcome will be assessed regularly from baseline through 6 hours post cannabis dose during experimental sessions.
Opioid severity is a participant-rated outcome that will be measured on a visual analog scale (0-100)
次要结局
未报告次要终点
研究者
Shanna Babalonis, PhD
Associate Professor
University of Kentucky