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Pregabalin as Treatment for Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring alcohol use disorder, alcohol abuse, treatment, lyrica

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia Univeristy-STARS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pregabalin

Arm Description

pregabalin up to daily dose of 600 mg

Outcomes

Primary Outcome Measures

Maximum Dose of Pregabalin:
Defined as the highest amount of medication per day maintained for a 7 day period.

Secondary Outcome Measures

Full Information

First Posted
August 17, 2017
Last Updated
August 17, 2020
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03256253
Brief Title
Pregabalin as Treatment for Alcohol Use Disorder
Official Title
An Open-Label Pilot Study of Pregabalin as Treatment for Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
alcohol use disorder, alcohol abuse, treatment, lyrica

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
open label pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pregabalin
Arm Type
Experimental
Arm Description
pregabalin up to daily dose of 600 mg
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
lyrica
Intervention Description
pregabalin up to 600 mg/day
Primary Outcome Measure Information:
Title
Maximum Dose of Pregabalin:
Description
Defined as the highest amount of medication per day maintained for a 7 day period.
Time Frame
over the course of the 8 week trial or participants' length of participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
john mariani, md
Organizational Affiliation
new york psychiatric institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia Univeristy-STARS
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34092158
Citation
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.
Results Reference
derived

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Pregabalin as Treatment for Alcohol Use Disorder

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