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

NCT03509285 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2024-11-07

No results posted yet for this study

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

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

Sponsors & Collaborators

  • SK Life Science, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-08
Primary Completion
2017-11-18
Completion
2017-12-15
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03509285 on ClinicalTrials.gov