Pregabalin as Treatment for Alcohol Use Disorder

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.

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