Pregabalin as Treatment for Alcohol Use Disorder

NCT ID: NCT03256253

Last Updated: 2020-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-15
• Study Completion Date: 2020-05-31

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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pregabalin

pregabalin up to daily dose of 600 mg

Group Type: EXPERIMENTAL

Pregabalin

Intervention Type: DRUG

pregabalin up to 600 mg/day

Interventions

Pregabalin

pregabalin up to 600 mg/day

Intervention Type: DRUG

Other Intervention Names

lyrica

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

John Mariani MD

Research psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

john mariani, md

Role: PRINCIPAL_INVESTIGATOR

new york psychiatric institute

Locations

Columbia Univeristy-STARS

New York, New York, United States

Countries

United States

References

Mariani JJ, Pavlicova M, Choi CJ, Brooks DJ, Mahony AL, Kosoff Z, Naqvi N, Brezing C, Luo SX, Levin FR. An open-label pilot study of pregabalin pharmacotherapy for alcohol use disorder. Am J Drug Alcohol Abuse. 2021 Jul 4;47(4):467-475. doi: 10.1080/00952990.2021.1901105. Epub 2021 Jun 5.

Reference Type: DERIVED

PMID: 34092158 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

7491

Identifier Type: -

Identifier Source: org_study_id