Modulation of Drug Intake: Evaluation of Opioid and Cannabinoid Interactions on Drug Self-Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Self-Administration
研究概览
简要总结
The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18-50
- •Experience with marijuana and opioids
- •General good health
- •Willing to live at the University of Kentucky Hospital (research unit) for approx. 6.5 weeks (meals are provided,
排除标准
- •Significant medical complications/conditions
研究组 & 干预措施
Double-blind marijuana/placebo administration
Participants will receive double-blind administration of vaporized marijuana/placebo
干预措施: Opioid (Drug)
Double-blind opioid/placebo administration
Participants will receive double-blind administration of intranasal opioid agonist/placebo
干预措施: Opioid (Drug)
Double-blind marijuana/placebo administration
Participants will receive double-blind administration of vaporized marijuana/placebo
干预措施: Marijuana (Drug)
Double-blind opioid/placebo administration
Participants will receive double-blind administration of intranasal opioid agonist/placebo
干预措施: Marijuana (Drug)
结局指标
主要结局
Self-Administration
时间窗: Collected once during each self-administration session
The number of units of drug earned in each session
Self-Administration of Drug Units Earned
时间窗: Through a progressive-ratio self-administration model given once per treatment condition throughout each 6 hour session
The number of units of drug (out of a total of 7) earned in each experimental condition. Participants work for some, none, or all of the available drug dose. For each dose condition, the number of drug units completed for drug was pulled from the raw data and averaged to yield one mean (SEM).
次要结局
- Subjective measures(Baseline, post-dose during each session (change from baseline is assessed); visual analog scales will be the primary measure (0-100, 0=not at all, 100=extremely))
- Heart rate(Baseline, post-dose during each session (change from baseline is assessed))
- Blood pressure(Baseline, post-dose during each session (change from baseline is assessed))
- Peak End-tidal Carbon Dioxide (EtCO2)(This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours).)
- Trough Respiration Rate(This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours).)
研究者
Shanna Babalonis, PhD
Assistant Professor
University of Kentucky