Modulation of Opiate Reward by NK1 Antagonism: A Laboratory-Based Proof of Concept Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome will be self-reported pleasurable opiate effect.
研究概览
简要总结
The objective of this study is to determine whether aprepitant blocks the opiate reward system in non-dependent opiate abusers, indicating its potential as a safe, non-addictive first line therapy for early heroin abuse.
详细描述
This initial proof-of-concept study focuses on evaluating whether an NK1 antagonist, aprepitant, can block opiate reward in non-dependent opiate experienced volunteers in response to a standard opiate challenge. Sixty subjects will be included in a randomized controlled study. Following a training challenge session, they will receive 1 week treatment with aprepitant or matching placebo, followed by a challenge session during which subjective and physiological responses to the opiate partial agonist buprenorphine will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Age 18 - 50
- •Current opiate use, without dependence
排除标准
- •Clinical diagnosis of opiate dependence
- •Positive urine screen for opiates on day of challenge sessions
- •Meet diagnostic criteria for any other substance abuse disorder except nicotine within the last 12 months.
- •Any ongoing prescription medication other than oral contraceptives or hormone replacement
- •Any serious medical condition which in the judgment of the investigators makes administration of opiates medically inappropriate.
研究组 & 干预措施
1
Aprepitant
干预措施: aprepitant (Drug)
2
Placebo
干预措施: Pseudo-placebo - buprenorphine (Drug)
结局指标
主要结局
The primary outcome will be self-reported pleasurable opiate effect.
时间窗: One week
次要结局
- The secondary outcome will be physiological opiate responses.(One week)