This randomized, single-dose, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of cenobamate in recreational drug users with sedative drug use experience. In the Qualification phase, subjects will receive a single dose of either alprazolam or placebo in a crossover design, with a wash-out period of at least 24 hours between treatments. Subjects who are clearly able to distinguish the positive control from placebo will be enrolled in the Treatment phase and will be randomized to single oral doses of cenobamate (2 dose levels), alprazolam (2 dose levels), and placebo in a double-blind, double-dummy, 5-way crossover design. Washout-periods between the 5 treatment periods in the Treatment phase will be at least 16 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
53
100 mg lactose tablets
Sugar pill manufactured to mimic cenobamate 100 mg tablet
0.5 mg and 1.0 mg alprazolam tablets
100 mg tablet
Vince & Associates Clinical Research, Inc
Overland Park, Kansas, United States
INC Research, Inc.
Toronto, Ontario, Canada
Pharmacodynamics using Visual Analogue Scales (VAS)
Subjective Effect of Drug Liking "at this moment" \[0-100 scale, 0=Strong Disliking, 50=Neither Like nor Dislike, 100=Strong Liking\]
Time frame: Measured for 24 hrs in each Treatment Period
Pharmacokinetics
Plasma concentrations of cenobamate and alprazolam
Time frame: Measured for 24 hrs in each Treatment Period
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Incidence, frequency, and severity of AEs and AEs of Special Interest (which include AEs related to drug reaction with eosinophilia and systemic symptoms \[DRESS\] and abuse-related adverse events)
Time frame: 21 weeks
Pharmacodynamics using Visual Analogue Scales (VAS)
Subjective Effect of Take Drug Again \[0-100 scale, 0=Definitely Not, 50=Neutral, 100=Definitely So\]
Time frame: Measured at 12 hr and 24 hr timepoints in each Treatment Period
Pharmacodynamics using Visual Analogue Scales (VAS)
Subjective Effect of Overall Drug Liking \[0-100 scale, 0=Strong Disliking, 50=Neither Like nor Dislike, 100=Strong Liking\]
Time frame: Measured at 12 hr and 24 hr timepoints in each Treatment Period
Pharmacodynamics using Visual Analogue Scales (VAS)
Subjective Effect of High \[0-100 scale, 0=Not at All,100=Extremely\]
Time frame: Measured for 24 hrs in each Treatment Period
Pharmacodynamics using Visual Analogue Scales (VAS)
Subjective Good Drug Effects \[0-100 scale, 0=Not at All,100=Extremely\]
Time frame: Measured for 24 hrs in each Treatment Period
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