NCT03509285

A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users

Randomized, Double-Blind, Double-Dummy, 5-Way Crossover Study to Evaluate the Abuse Potential of Cenobamate Relative to Alprazolam and Placebo When Administered Orally in Non-Dependent, Recreational Drug Users with Sedative Experience

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Alprazolam Placebo	100 mg lactose tablets
DRUG	Cenobamate placebo	Sugar pill manufactured to mimic cenobamate 100 mg tablet
DRUG	Alprazolam	0.5 mg and 1.0 mg alprazolam tablets
DRUG	Cenobamate	100 mg tablet

Timeline

• Start date: 2017-03-08
• Primary completion: 2017-11-18
• Completion: 2017-12-15
• First posted: 2018-04-26
• Last updated: 2024-11-07

Locations

2 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study