NCT01149824已完成不适用
A Double Blind Placebo Controlled Ascending Dose Pharmacodynamic and Tolerability Study of 100 to 4000 µg of Sublingual Salvinorin A
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- To determine an active but tolerable sublingual dose (range 100 to 4000 µg) of Salvinorin A (SA) in experienced subjects.
研究概览
简要总结
In this study, our aim is to determine an active but tolerable sublingual dose (range 100 to 4000 µg) of Salvinorin A (SA) in experienced subjects. This study is an ascending-dose, placebo-controlled, single-site design in 8 Salvia-experienced subjects. Subjects will receive SA doses from 0-4000 µg. Doses will be separated by at least one day. The first two doses (0 and 100µg) will be double-blinded while the last four (250, 500, 1000, 2000 and 4000µg) will be single-blind.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 21-45
- •Experienced with hallucinogenic amounts of SA
- •Good physical and mental health
- •Able to give adequate informed consent
排除标准
- •Any medical or psychiatric condition which, in the investigators' opinion, would preclude safe or consistent participation
- •Significant acute or chronic medical disease
- •Female who is pregnant, lactating, or plans to become pregnant during the study period and within one month after study drug administration
研究组 & 干预措施
Dose Escalating
Other
干预措施: Salvinorin A (Drug)
Dose Escalating
Other
干预措施: Placebo (Drug)
结局指标
主要结局
To determine an active but tolerable sublingual dose (range 100 to 4000 µg) of Salvinorin A (SA) in experienced subjects.
时间窗: 2 hours
次要结局
未报告次要终点
研究者
John Mendelson, MD
Senior Scientist
California Pacific Medical Center Research Institute
相似试验
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of AEB071HealthyNCT00409929Novartis16
已完成
1 期
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy SubjectsInflammatory Bowel DiseaseNCT01221818Eisai Inc.48
已完成
1 期
Safety, Tolerability and Pharmacokinetics Study of LY03005Major Depressive DisorderNCT02055300Luye Pharma Group Ltd.88
已完成
1 期
Multiple Ascending Dose Study of GLPG0492 in Healthy SubjectsHealthyNCT01397370Galapagos NV24
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of GLPG0634 in Healthy SubjectsHealthyNCT01419990Galapagos NV16