Status:
COMPLETED
A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This randomized, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of RO4917838 in recreational drug users. In a pre-study (Part 1), subjects will receive a s...
Eligibility Criteria
Inclusion
- Healthy male or female volunteers, 18 to 55 years of age inclusive
- Recreational drug abuse experience (\>/= 10 times lifetime abuse of a CNS depressant, \>/= 1 abuse of CNS depressant in the previous 3 months
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- Main study (Part 2): Able to differentiate between diazepam and placebo
Exclusion
- History of any significant disease or disorder
- History or current diagnosis of substance dependence (excluding caffeine and nicotine)
- Currently seeking or history of participating in treatment for substance-related disorders, including successful completion of such treatment
- Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator
- Positive for hepatitis B, hepatitis C or HIV infection
- Pregnant or lactating women
- Participation in an investigational drug or device study within the last 30 days prior to Day 1 of the study
- Confirmed positive drug screening at screening / any Day -1 (allowed positive THC at screening and any Day -1 and positive benzodiazepine at screening only)
- Positive alcohol breath test at screening / any Day -1
- Heavy smoker (\> 20 cigarettes, \> 8 pipefuls or \> 8 cigars per day)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT01438749
Start Date
October 1 2011
End Date
May 1 2012
Last Update
November 2 2016
Active Locations (1)
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1
Salt Lake City, Utah, United States, 84106