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Pregabalin Trial for the Treatment of Alcohol Use Disorder (GABI2)

Primary Purpose

Alcohol Use Disorder

Status

Suspended

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Pregabalin

Placebo

About this trial

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

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 Alcohol use disorder, that in the investigator's judgment likely requiring ongoing dosage adjustments of their current medications or requiring changes in their medication and/or might require intervention over the course of the study, including schizophrenia, schizoaffective disorder, psychotic disorders other than transient psychosis due to drug abuse, bipolar disorder, and current suicidality with plan and intent. Individuals who are currently stable on a psychotropic medication for at least 3 months may be included if in the investigator's opinion the psychotropic medication is compatible with the study medication (pregabalin). The medications being allowed are commonly used antidepressants, including the SSRIs (e.g., fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram), SNRI's (e.g., venlafaxine, desvenlafaxine, duloxetine), and bupropion.
Evidence of moderate-to-severe alcohol withdrawal Clinical Institute Withdrawal Assessment (revised version) (CIWA-Ar score ≥10)
History of alcohol withdrawal seizures or alcohol withdrawal delirium
History of allergic reaction to candidate medication (pregabalin)
Pregnancy, lactation, or failure in female 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 dependence. A diagnosis of a mild substance use disorder will not be exclusionary, as long as the current primary substance use disorder is alcohol dependence.
Are legally mandated to participate in alcohol use disorder treatment program

Sites / Locations

Nyspi-Stars

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pregabalin

Placebo

Arm Description

Treatment with pregabalin administered in 75 mg and 100 capsules in dosages up to 600 mg per day for up to 8 weeks (including a 3 week titration run up) followed by a one week taper.

Individuals will receive the placebo capsules that appear identical to the pregabalin capsules and will receive the same number of capsules.

Outcomes

Primary Outcome Measures

Change in proportion of heavy drinking days

Change in heavy drinking days as quantified by the proportion of heavy drinking days (defined as any day where the number of standard drinks was at least 5 for men and at least 4 for women) per week as measured by the timeline follow-back (TLFB) method.

Secondary Outcome Measures

Full Information

NCT ID

NCT04322305

First Posted

March 24, 2020

Last Updated

September 1, 2023

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT04322305

Brief Title

Pregabalin Trial for the Treatment of Alcohol Use Disorder

Acronym

GABI2

Official Title

A Double-blind, Placebo-Controlled Trial of Pregabalin for the Treatment of Alcohol Use Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Suspended

Why Stopped

U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume recruitment after OHRP has approved the resumption of research.

Study Start Date

January 11, 2021 (Actual)

Primary Completion Date

July 31, 2024 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

In a 10-week randomized double-blind placebo-controlled outpatient pilot trial the efficacy of pregabalin in the treatment of alcohol dependence will be studied in 50 treatment-seeking outpatients. Participants will report 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.

Detailed Description

In a 10-week double-blind placebo controlled outpatient clinical trial, the safety and efficacy ofpregabalin will be tested in 50 outpatients with Alcohol Use Disorder.Participants will be randomly allocated (1:1) to receive pregabalin or an identical-appearing, inert placebo. All study medication (placebo and pregabalin) will be over-capsulated with riboflavin to assess compliance. Pregabalin will be administered in 75 mg and 100 capsules; placebo capsules will appear identical to the pregabalin capsules. Participants in both study arms will receive the same number of capsules. Pregabalin will be titrated over a 3-week period to the FDA maximum (600 mg per day) or the maximum tolerated dose. Study visits will occur daily for the first 4 days of the study period, then approximately every other day for the remainder of week 1, for a total of 5 study visits (study days 1,2,3,4, and 5 or 7). During the second week, study visits will continue every other day for a total of 3 study visits (study days 8,10, and 12). During the remainder of the 8-week medication study period, study visits will occur twice weekly. There will be two visits during a post-study taper week (week 9) and a follow-up visit during week 10. One visit per week will be with the research psychiatrist. All participants will have a weekly supportive behavioral treatment session with the research psychiatrist using a manual designed for pharmacotherapy trials in subjects with alcohol use disorders

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, treatment, pregabalin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomized Double blind, placebo controlled trial

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Pregabalin will be administered in 75 mg and 100 capsules; placebo capsules will appear identical to the pregabalin capsules. Participants in both study arms will receive the same number of capsules.

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pregabalin

Arm Type

Experimental

Arm Description

Treatment with pregabalin administered in 75 mg and 100 capsules in dosages up to 600 mg per day for up to 8 weeks (including a 3 week titration run up) followed by a one week taper.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Individuals will receive the placebo capsules that appear identical to the pregabalin capsules and will receive the same number of capsules.

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Other Intervention Name(s)

Lyrica

Intervention Description

Pregabalin will be provided in 75 and 100 mg capsules twice daily for a maximum dose of 600 mg/day or the maximum tolerated dose over the 8 week medication phase and followed by a one week taper.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo capsules will be provided twice daily over 8 weeks and one week taper..

Primary Outcome Measure Information:

Title

Change in proportion of heavy drinking days

Description

Time Frame

measured weekly over the 8 weeks of the medication phase of the trial or length of each individual's participation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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 Alcohol use disorder, that in the investigator's judgment likely requiring ongoing dosage adjustments of their current medications or requiring changes in their medication and/or might require intervention over the course of the study, including schizophrenia, schizoaffective disorder, psychotic disorders other than transient psychosis due to drug abuse, bipolar disorder, and current suicidality with plan and intent. Individuals who are currently stable on a psychotropic medication for at least 3 months may be included if in the investigator's opinion the psychotropic medication is compatible with the study medication (pregabalin). The medications being allowed are commonly used antidepressants, including the SSRIs (e.g., fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram), SNRI's (e.g., venlafaxine, desvenlafaxine, duloxetine), and bupropion. Evidence of moderate-to-severe alcohol withdrawal Clinical Institute Withdrawal Assessment (revised version) (CIWA-Ar score ≥10) History of alcohol withdrawal seizures or alcohol withdrawal delirium History of allergic reaction to candidate medication (pregabalin) Pregnancy, lactation, or failure in female 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 dependence. A diagnosis of a mild substance use disorder will not be exclusionary, as long as the current primary substance use disorder is alcohol dependence. Are legally mandated to participate in alcohol use disorder treatment program

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

Nyspi-Stars

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)

IPD Sharing Time Frame

beginning 12 months and ending 5 years after article publication

IPD Sharing Access Criteria

to researcher who provides a methodologically sound proposal to achieve aims in the approved proposal

Learn more about this trial

Pregabalin Trial for the Treatment of Alcohol Use Disorder

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