Pregabalin Trial for the Treatment of Alcohol Use Disorder

NCT04322305 | Suspended Phase 2 DMC FDA Drug

• 2 other identifiers: 7977R21AA028371
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

alcohol use disorder; treatment; pregabalin

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

Pregabalin

EXPERIMENTAL

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.

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Pregabalin DRUG

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.

Also known as: Lyrica

Pregabalin

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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
• Are legally mandated to participate in alcohol use disorder treatment program

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Nyspi-Stars

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• john mariani, MD

  New York Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Model Details: Randomized Double blind, placebo controlled trial

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: January 11, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: beginning 12 months and ending 5 years after article publication
• Access Criteria: to researcher who provides a methodologically sound proposal to achieve aims in the approved proposal

Locations

US (1)