Study to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users
Phase 1
Completed
- Conditions
- Recreational CNS Depressant Use
- Interventions
- Registration Number
- NCT00902772
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to examine the abuse potential of AZD7325.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Recreational CNS depressant use, defined as at least 10 lifetime occasions of non-medical use of drugs with depressant/sedative properties and at least 1 non-medical use in the year prior to screening
- Body mass index (BMI) within the range of 19.0 to 33.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening
- Willing and able to abide by all study requirements and restrictions
Exclusion Criteria
- Unwillingness of inability to abstain from recreational drug use for the duration of the study from screening until follow-up
- Positive breath alcohol test prior to dosing
- Clinically significant abnormalities on physical examination, medical history, 12-lead ECG, vital signs, or safety laboratories
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description G AZD7325 AZD7325 A Placebo Placebo F AZD7325 AZD7325 E AZD7325 AZD7325 B Lorazepam Lorazepam C Lorazepam Lorazepam D Lorazepam Lorazepam
- Primary Outcome Measures
Name Time Method Visual Analog Scales Daily during Visit 2 through 9
- Secondary Outcome Measures
Name Time Method Columbia Suicide-Severity Rating Scale Prior to each treatment period
Trial Locations
- Locations (1)
Research Site
🇨🇦Toronto, Ontario, Canada