Pregabalin as Treatment for Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title:

An Open-Label Pilot Study of Pregabalin as Treatment for Alcohol Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256253
• Other study ID #: 7491
• Status: Completed
• Phase: Phase 2
• Start date: February 15, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: August 2020
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Disease

Intervention

Drug:
• Pregabalin
pregabalin up to 600 mg/day

Locations

Country	Name	City	State
United States	Columbia Univeristy-STARS	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Dose of Pregabalin:	Defined as the highest amount of medication per day maintained for a 7 day period.	over the course of the 8 week trial or participants' length of participation