Interactions of Marijuana and Opioids: Pharmacodynamic Effects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Subject-Rated Outcome - VAS Drug Liking
研究概览
简要总结
This study will examine the effects of doses of marijuana/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
This is a randomized, double-blind, double-dummy, placebo-controlled design
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy adults ages 18-50
- •Current non-medical use of opioids and marijuana
排除标准
- •Physical dependence on opioids, alcohol benzodiazepines/sedative/hypnotics
- •Seeking treatment for drug use
- •Significant medical problems
研究组 & 干预措施
Vaporized Marijuana
Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.
干预措施: Vaporized Marijuana (Drug)
Vaporized Marijuana
Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.
干预措施: Placebo (Drug)
Opioid Agonist
Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).
干预措施: Opioid Agonist (Drug)
Opioid Agonist
Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).
干预措施: Placebo (Drug)
Opioid Agonist/Marijuana Combination
Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.
干预措施: Vaporized Marijuana (Drug)
Opioid Agonist/Marijuana Combination
Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.
干预措施: Opioid Agonist (Drug)
Placebo
Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Subject-Rated Outcome - VAS Drug Liking
时间窗: This outcome (visual analog scores, scale of 0-100) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.
Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores.
次要结局
- Change in Diastolic Blood Pressure(Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.)
- Change in Oxygen Saturation(Oxygen saturation was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.)
- Change in Respiration Rate(Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.)
- Change in Systolic Blood Pressure(Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.)
研究者
Shanna Babalonis, PhD
Principal Investigator
University of Kentucky