Interactions of Alcohol and Opioids: Pharmacodynamic Effects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sharon Walsh
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking
研究概览
简要总结
This study will examine the effects of doses of alcohol/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
- Crossover
- 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, within-subjects design
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults ages 21-55
- •Current non-medical use of opioids
- •Previous alcohol use
排除标准
- •Physical dependence on opioids, alcohol, or benzodiazepines/sedative/hypnotics
- •Seeking treatment for drug use
- •Significant medical problems
研究组 & 干预措施
Alcohol
Participants will receive experimental doses of active or placebo alcohol, p.o. Alcohol/placebo will be administered once per session.
干预措施: Alcohol (Drug)
Opioid Agonist
Participants will receive non-therapeutic, experimental doses of an active opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered orally
干预措施: Opioid Agonist (Drug)
Opioid Agonist/Alcohol Combination
Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.
干预措施: Alcohol (Drug)
Opioid Agonist/Alcohol Combination
Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.
干预措施: Opioid Agonist (Drug)
结局指标
主要结局
Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking
时间窗: These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)
Participants rated their subjective drug liking on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater drug liking. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM).
次要结局
- Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel?(These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session))
- Trough Oxygen Saturation(Oxygen Saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).)
- Peak Cold Pressor Test Threshold(Cold Pressor Test Threshold was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).)
研究者
Sharon Walsh
Director of the Center on Drug and Alcohol Research
University of Kentucky