Carisbamate as a Potential Treatment for Alcohol Dependence
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|ClinicalTrials.gov Identifier: NCT02435381|
Recruitment Status : Unknown
Verified July 2017 by Thomas Newton, Baylor College of Medicine.
Recruitment status was: Active, not recruiting
First Posted : May 6, 2015
Last Update Posted : July 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence Alcohol Abuse Substance Abuse||Drug: Carisbamate Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Carisbamate as a Potential Treatment for Alcohol Dependence|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Placebo Comparator: Placebo
Participants will receive placebo from days 2- 4.
Placebo treatment only
Other Name: Sugar Pill
Active Comparator: Carisbamate
Participants will receive carisbamate 600mg qd from days 2- 4.
600mg Orally on days 2-4
Other Name: YKP 509
- Effects of carisbamate on the positive subjective effects of alcohol [ Time Frame: 2 hours post alcohol administration ]Subjective effects (after consuming carisbamate and alcohol) will be assessed using a 10-item visual analog scale (VAS).
- physiologic effects of carisbamate [ Time Frame: 2 hours post alcohol administration ]systolic and diastolic blood pressure will be monitored after consuming carisbamate and alcohol
- physiologic effects of carisbamate [ Time Frame: 2 hours post alcohol administration ]pulse will be monitored after consuming carisbamate and alcohol
- physiologic effects of carisbamate [ Time Frame: 2 hours post alcohol administration ]ECG will be monitored after consuming carisbamate and alcohol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435381
|United States, Texas|
|Michael E. DeBakey VA Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Thomas F Newton, M.D||Baylor College of Medicine|