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 single dose of either diazepam or placebo in an inpatient crossover design, with a wash-out period of at least 10 days between treatments. Subjects who are clearly able to distinguish the positive control from placebo will be enrolled in the main study (Part 2) and will be randomized to single oral doses of RO4917838 (3 dose levels), diazepam and placebo in a double-blind, double-dummy inpatient crossover design. Washout-periods between the 5 treatment periods in Part 2 will be at least 10 days.
Study Type
INTERVENTIONAL
Masking
DOUBLE
Enrollment
177
Single dose
Single doses (3 dose levels)
Single dose
Unnamed facility
Salt Lake City, Utah, United States
Pharmacodynamics: Abuse potential measured by Visual analogue scales (VAS)
Time frame: approximately 11 months
Safety: Incidence of adverse events
Time frame: approximately 11 months
Pharmacokinetics: plasma concentrations of RO4917838
Time frame: approximately 11 months
Pharmacodynamics: Addiction Research Center Inventory (ARCI) subscales
Time frame: approximately 11 months
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