A118G SNP and OPRM1 Gene Opioid-Mediated Effects in Humans
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Self-report Visual Analog Ratings of HIGH
研究概览
简要总结
Within-subject, double-blind, placebo-controlled examination of opioid abuse potential in healthy individuals as a function of A118G SNP on the OPRM1 gene.
详细描述
Participants completed a 5-day, within-subject, double-blind, placebo-controlled, randomized, human laboratory abuse potential trial. Healthy individuals were admitted to a residential research unit for 5 consecutive days. Blood samples were drawn for genome wide analyses using the Global Screening Array on day 1. Participants were administered an oral dose of the opioid hydromorphone (4mg) on day 2 of the study. Persons who did not evidence strong agonist effects then proceeded into the randomized period wherein they received 0mg, 2mg, and 8mg of oral hydromorphone on the remaining three study days. The order of dosing was randomized, with only 1 dose administered per day and all participants receiving 1 exposure to each dose. Outcomes were standard human abuse potential metrics, including self-reported drug effects and feeling high. Data were analyzed as a function of the A118SNP on the OPRM1 gene that codes for the mu opioid receptor. The overall aim was to determine whether signal for abuse potential among persons with no history of opioid misuse was associated with genotype.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Neither participants nor staff were informed of the class of drugs under investigation. Strict blinding was maintained.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo (oral)
Within-subject double-blind, administration of placebo oral capsule. Order of dose randomized session days 3-5.
干预措施: Within-subject test of blinded study medication (Drug)
Hydromorphone (oral) 2mg
Within-subject double-blind, administration of hydromorphone via oral capsule. Order of dose randomized session days 3-5.
干预措施: Within-subject test of blinded study medication (Drug)
Hydromorphone (oral) 4mg
Hydromorphone oral capsule administered in double-blind manner on Day 2 as first study drug administration. Hydromorphone 4mg dosing day was set for safety purposes and non-randomized.
干预措施: Within-subject test of blinded study medication (Drug)
Hydromorphone (oral) 8mg
Within-subject double-blind, administration of hydromorphone via oral capsule. Order of dose randomized session days 3-5.
干预措施: Within-subject test of blinded study medication (Drug)
结局指标
主要结局
Self-report Visual Analog Ratings of HIGH
时间窗: 30 minutes after study drug administration
Peak visual analog rating scale values of HIGH (rated on 0-100 scale with higher scores indicating higher feeling of being HIGH) collected at 30 minute intervals post-drug administration for 6 hours.
Self-report Visual Analog Ratings of DRUG EFFECT
时间窗: 30 minutes after study drug administration
Peak visual analog rating scale values of DRUG EFFECT (rated on 0-100 scale with higher scores indicating higher drug effect) collected at 30 minute intervals post-drug administration for 6 hours.
次要结局
未报告次要终点