Recreational CNS depressant use Not Applicable Recreational CNS depressant use
Conditions
Interventions
Participants are assigned, in ascending order, a unique randomization number to identify their sequence of study treatments. Subjects receive all 5 treatments in the order specified by the treatment s
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is Emax (maximum effect) on the Drug Liking Visual Analogue Scale (“at this moment”), assessed before taking the study drug and at 30 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours after taking the study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacodynamic endpoints, assessed before and at 30 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours after taking the study drug. This is assessed using the sum of all Visual Analog Scales used in the study (scales for balance of effects, positive subjective effects, negative subjective effects, sedative subjective effects and other drug effects) and the 49-item Addiction Research Center Inventory (ARCI-49) 2. Pharmacokinetic endpoints, including maximum observed plasma concentration, time to maximum observed plasma concentration, area under the plasma concentration, terminal elimination half-life, total systemic clearance and volume of distribution, assessed by taking blood samples about 15 minutes, 30 minutes, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, and 24 hours after taking the study drug 3. Safety endpoints: 3.1. Adverse events, assessed at every visit and in the treatment periods before taking the study drug and at 30 minutes and 1, 1.5, 2, 3, 4, 6, 12, and 24 hours after taking the study drug 3.2. Vital signs, assessed at every visit and in the treatment periods before taking the study drug and at 30 minutes and 1, 1.5, 2, 3, 4, 6, 12, and 24 hours after taking the study drug 3.3. ECG, measured at every visit 3.4. Clinical laboratory tests, completed at every visit 3.5. Physical examination, completed at every visit 3.6. Columbia-Suicide Severity Rating Scale, assessed in every treatment period (day before drug intake and 24 hours after taking the study drug) and in the follow up visit | — |
Countries
Canada
Outcome results
None listed