NCT02435381

Carisbamate as a Potential Treatment for Alcohol Dependence

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This within-subjects placebo-controlled experimental protocol will assess the effects of carisbamate (600mg qd) on the positive subjective effects of alcohol in non-treatment-seeking alcohol-dependent volunteers. Participants will receive study drug (carisbamate or placebo) from days 2- 4. On day 4, study drug will be followed by alcohol (0.8g/kg; 16% by volume) and a placebo beverage (1% by volume as a mask), both separated by 2 hours. Physiologic, subjective effects and BAL will be obtained after the alcohol challenges. Participants will be discharged on day 4 and asked to return a week later to repeat the study under the alternate study drug condition (active carisbamate vs. placebo).

Conditions

• Alcohol Dependence
• Alcohol Abuse
• Substance Abuse

Interventions

Type	Name	Description
DRUG	Carisbamate	600mg Orally on days 2-4
DRUG	Placebo	Placebo treatment only

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-09-30
• Completion: 2013-09-30
• First posted: 2015-05-06
• Last updated: 2021-03-02
• Results posted: 2021-03-02

Locations

1 site across 1 country: United States