Status:
COMPLETED
Pregabalin as Treatment for Alcohol Use Disorder
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The proposed protocol is an 8 week open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. The primary objective of the study is t...
Detailed Description
The proposed protocol is an open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. Pregabalin is commonly used for the treatment ...
Eligibility Criteria
Inclusion
- Meets DSM-5 criteria for current alcohol use disorder
- Reports drinking a minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week over the past 28 days
- Between the ages of 18 and 65
- Able to provide informed consent and comply with study procedures
Exclusion
- Subjects with any current psychiatric disorder as defined by DSM-5, other than AUD, that in the investigator's judgment might require intervention over the course of the study.
- Subjects receiving psychotropic medication treatment
- Evidence of moderate-to-severe alcohol withdrawal (CIWA-Ar \> 13)
- History of alcohol withdrawal seizures or alcohol withdrawal delirium
- History of allergic reaction to candidate medication (pregabalin)
- Pregnancy, lactation, or failure in females patients to use adequate contraceptive methods
- Unstable physical disorders which might make participation hazardous
- Subjects who have a current DSM-5 diagnosis of moderate or severe substance use disorder, with the exception of alcohol, nicotine and caffeine use disorders. A diagnosis of a mild substance use disorder will not be exclusionary, as long as the current primary substance use disorder is alcohol.
- Are legally mandated to participate in alcohol use disorder treatment program
- Cognitively impaired
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03256253
Start Date
February 15 2018
End Date
May 31 2020
Last Update
August 31 2020
Active Locations (1)
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1
Columbia Univeristy-STARS
New York, New York, United States, 10019