Pregabalin as Treatment for Alcohol Use Disorder

• Status: Completed
• Trial end date: 2020-05-31
• Target enrollment: 0
• Participant gender: All

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 to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Treatments: Ethanol; Pregabalin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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