Carisbamate as a Potential Treatment for Alcohol Dependence

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT02435381
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Alcohol Abuse
  • Alcohol Dependence
  • Substance Abuse

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Carisbamate — DRUG
    600mg Orally on days 2-4
  • Placebo — DRUG
    Placebo treatment only

Study Details

The purpose of this study is to determine the effects of treatment with carisbamate compared to treatment with placebo, on alcohol-induced stimulant and subjective effects in non-treatment seeking alcohol-dependent human volunteers.

Key Dates

Start date
Feb 28, 2013
Status verified
Feb 2021
Primary completion
Sep 30, 2013
Completion
Sep 30, 2013

Study Design

Enrollment
11 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Placebo Comparator: Placebo
    Participants will receive placebo from days 2- 4.
  • Active Comparator: Carisbamate
    Participants will receive carisbamate 600mg qd from days 2- 4.

Primary Outcome Measure

Mean Biphasic Alcohol Effects Scale (BAES) Scores [ Time Frame: 15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages, stimulant ratings ]

Locations (1)

FacilityCityStateZIPSite coordinators
Michael E. DeBakey VA Medical CenterHoustonTexas77030-

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