Pregabalin as Treatment for Alcohol Use Disorder

August 17, 2020 updated by: John Mariani MD, New York State Psychiatric Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • Columbia Univeristy-STARS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pregabalin
pregabalin up to daily dose of 600 mg
Drug: Pregabalin
pregabalin up to 600 mg/day
Other Names:
  • lyrica

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Dose of Pregabalin:
Time Frame: 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.
over the course of the 8 week trial or participants' length of participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Investigators

  • Principal Investigator: john mariani, MD, New York Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

August 17, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (Actual)

August 21, 2017

Study Record Updates

Last Update Posted (Actual)

August 31, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7491

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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