NCT03256253

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

August 13, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

August 17, 2017

Results QC Date

July 21, 2020

Last Update Submit

August 17, 2020

Conditions

Alcohol Use Disorder

Keywords

alcohol use disorderalcohol abusetreatmentlyrica

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

pregabalin

EXPERIMENTAL

pregabalin up to daily dose of 600 mg

Drug: Pregabalin

Interventions

PregabalinDRUG

pregabalin up to 600 mg/day

Also known as: lyrica
pregabalin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Are legally mandated to participate in alcohol use disorder treatment program
  • Cognitively impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia Univeristy-STARS

New York, New York, 10019, United States

Location

Related Publications (1)

  • 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.

    PMID: 34092158DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
John Mariani MD
Organization
New York State Psychiatric Institute
john.mariani@nyspi.columbia.edu
6467748181

Study Officials

  • john mariani, md

    new york psychiatric institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: open label pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research psychiatrist

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 21, 2017

Study Start

February 15, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2020

Last Updated

August 31, 2020

Results First Posted

August 13, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)