The Effects of Buprenorphine on Responses to Verbal Tasks
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine
研究概览
简要总结
In this study, the investigators will examine the effects of buprenorphine, as compared to placebo, upon physiological, subjective, and hormonal responses to a stressful speech task and a non-stressful control task in healthy adults. There is strong evidence in support of the role of endogenous opioids and opiates in mediating social behavior in humans and other animals, and particularly, in social distress. Recently it has been shown that buprenorphine, a partial mu-opioid agonist, reduces sensitivity to recognition of fearful facial expressions in humans. Here, the investigators propose to further explore the role of the opioid system in mediating stress responses in humans through the use of buprenorphine. The investigators hypothesize that buprenorphine with reduce both physiological and subjective measures of stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •ages 18-40 years
- •high school education
- •fluent in English
排除标准
- •history of adverse drug reactions
- •taking oral contraceptives or planning to become pregnant
- •taking any medications
- •night shift workers
- •drink more than 4 alcoholic or caffeinated drinks per day
研究组 & 干预措施
Placebo group
Healthy volunteers receive placebo during session (within-subjects design).
干预措施: Placebo (Drug)
buprenorphine (0.2 mg) group
Healthy volunteers receive buprenorphine (0.2 mg) during session (within-subjects design).
干预措施: Buprenorphine 0.2 MG Sublingual Tablet (Drug)
buprenorphine (0.4 mg) group
Healthy volunteers receive buprenorphine (0.4 mg) during session (within-subjects design).
干预措施: Buprenorphine 0.4 MG Sublingual Tablet (Drug)
结局指标
主要结局
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine
时间窗: End of study - (Pre-administration of drug or placebo (Time 0), and approx 210 minutes after drug/placebo admin), End of study (210 min) shown
The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0 -100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
次要结局
未报告次要终点