Cannabis Modulation of Outcomes Related to Opioid Use Disorder: Opioid Withdrawal, Abuse Potential and Safety
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change from Baseline - Opioid Withdrawal Severity - Visual Analog Scale (VAS)
研究概览
简要总结
This study plans to enroll participants with opioid use disorder who are not currently seeking treatment to assess the effects of cannabis on opioid withdrawal and other related outcomes.
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
- 是
入选标准
- •Current opioid use disorder
排除标准
- •Current medical conditions that require medical management
研究组 & 干预措施
Intranasal Opioid Agonist
Participants will receive non-therapeutic, experimental doses of an opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered intransally (snorting).
干预措施: Inhaled vaporized cannabis (Drug)
Vaporized cannabis
Participants will receive non-therapeutic, experimental doses of active or placebo vaporized cannabis. Active cannabis/placebo will be administered once per session and will be administered via a vaporizer.
干预措施: Intransal opioid (Drug)
Vaporized cannabis
Participants will receive non-therapeutic, experimental doses of active or placebo vaporized cannabis. Active cannabis/placebo will be administered once per session and will be administered via a vaporizer.
干预措施: Inhaled vaporized cannabis (Drug)
Intranasal Opioid Agonist
Participants will receive non-therapeutic, experimental doses of an opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered intransally (snorting).
干预措施: Intransal opioid (Drug)
结局指标
主要结局
Change from Baseline - Opioid Withdrawal Severity - Visual Analog Scale (VAS)
时间窗: Change from baseline
Subjective ratings of opioid withdrawal severity on visual analog scale (scale 0-100; 0 = not at all, 100 = extremely)
次要结局
- Change from Baseline - Opioid Drug Liking - Visual Analog Scale (VAS)(Change from baseline)
- Change from Baseline - Respiration(Change from baseline)
研究者
Shanna Babalonis, PhD
Principal Investigator
University of Kentucky