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

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
SK Life Science, Inc.
Study ID
NCT03509285
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 8, 2017
Status verified
Nov 2024
Primary completion
Nov 18, 2017
Completion
Dec 15, 2017

Study Design

Enrollment
53 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Qualification Y
    Placebo; administered orally as a single dose of 2 x 100 mg lactose tablets, over-encapsulated (alprazolam placebo)
  • Active Comparator: Qualification Z
    Alprazolam 2.0 mg; administered orally as a single dose of 2 x 1.0 mg alprazolam tablets, over-encapsulated
  • Placebo Comparator: Treatment A
    Placebo; administered orally as a single dose of 4 x cenobamate-matched placebo tablets and 3 x 100 mg lactose tablets, over-encapsulated (alprazolam placebo)
  • Active Comparator: Treatment B
    Alprazolam 1.5 mg; administered orally as a single dose of 3 x 0.5 mg alprazolam tablets, over-encapsulated and 4 x cenobamate-matched placebo tablets
  • Active Comparator: Treatment C
    Alprazolam 3.0 mg; administered orally as a single dose of 3 x 1.0 mg alprazolam tablets, over-encapsulated and 4 x cenobamate-matched placebo tablets
  • Experimental: Treatment D
    Cenobamate, 200 mg; administered orally as a single dose of 2 x 100 mg cenobamate tablets, 2 x cenobamate-matched placebo tablets, and 3 x 100 mg lactose tablets, over-encapsulated (alprazolam placebo)
  • Experimental: Treatment E
    Cenobamate, 400 mg; administered orally as a single dose of 4 x 100 mg cenobamate tablets and 3 x 100 mg lactose tablets, over-encapsulated (alprazolam placebo)

Primary Outcome Measure

Pharmacodynamics using Visual Analogue Scales (VAS) [ Time Frame: Measured for 24 hrs in each Treatment Period ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vince & Associates Clinical Research, IncOverland ParkKansas66212-

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Vince & Associates Clinical Research, Inc· Overland Park, KS

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