A Single-Dose, Double-Blind, Randomized, Active- and Placebo-Controlled Crossover Study to Evaluate the Abuse Potential of Silexan in Healthy Recreational Drug Users

Dr. Willmar Schwabe GmbH & Co. KG0 个研究点目标入组 40 人开始时间: 2018年9月10日最近更新: 2018年9月24日

适应症

试验速览

暂无简介。

•1. Healthy
•2. Aged 18-55 years
•3. Current recreational drug user who has used CNS depressants for recreational, non-therapeutic purposes,:
•3.1. At least 10 times in their lifetime, and
•3.2. At least 1 time in the 12 weeks before screening
•4. Sufficient ability to speak, read and understand English, to allow completion of all study assessments

•1. Substance or alcohol dependence (excluding nicotine and caffeine) within the past 12 months, as defined by the DSM-IV, and/or subjects who have ever been in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence;
•2. History or presence of clinically significant abnormality as assessed by physical examination, medical history, 12-lead ECG, or vital signs, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results
•3. Use of a prohibited medication (assessed by the investigator on a case-by-case basis)
•4. Positive urine drug screen or positive breath alcohol test
•5. Treatment with an investigational drug within 30 days prior to first drug administration
•6. Concurrently enrolled in any research

发起方