Pregabalin as Treatment for Alcohol Use Disorder

New York State Psychiatric Institute

Status and phase

Completed

Phase 2

Conditions

Alcohol Use Disorder

Treatments

Drug: Pregabalin

Study type

Interventional

Funder types

Other

Identifiers

NCT03256253

7491

Details and patient eligibility

About

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.

Full 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 of pain issues such as fibromyalgia (chronic pain in your body), diabetic nerve pain, spinal cord injury nerve, and pain after shingles. We plan to enroll 20 participants in an 8-week trial.The ideal dosing, tolerability, and safety of pregabalin will be tested in outpatients with Alcohol Use Disorder (AUD). The primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.

Enrollment

18 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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