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Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02435381
Study type Interventional
Source Baylor College of Medicine
Contact
Status Completed
Phase Phase 1/Phase 2
Start date February 2013
Completion date September 30, 2013

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