Pregabalin as Treatment for Alcohol Use Disorder

Phase 2

Completed

• Conditions: Alcohol Use Disorder
• Interventions: Drug: Pregabalin

• Registration Number: NCT03256253
• Lead Sponsor: New York State Psychiatric Institute

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

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 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.

Study Timeline

• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-21
• Study Start: 2018-02-15
• Primary Completion: 2019-05-31
• Study Completion: 2020-05-31
• Results First Submitted: 2020-07-21
• Results First Submitted QC: 2020-07-21
• Status Verified: 2020-08
• Results First Posted: 2020-08-13
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pregabalin	Pregabalin	pregabalin up to daily dose of 600 mg

Primary Outcome Measures

Name	Time	Method
Maximum Dose of Pregabalin:	over the course of the 8 week trial or participants' length of participation	Defined as the highest amount of medication per day maintained for a 7 day period.

Trial Locations

Locations (1)

Columbia Univeristy-STARS; 🇺🇸 New York, New York, United States