CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Pregabalindrug
Likely dose
Pregabalin up to 600 mg/dayAI-extracted
Key inclusion· 4
  • ✓Meets DSM-5 criteria for current alcohol use disorder
  • ✓Minimum heavy drinking: ≥5 drinks/day for men or ≥4 drinks/day for women, ≥4 days per week over past 28 days
  • ✓Age 18–65 years
  • ✓Able to provide informed consent and comply with study procedures
Key exclusion· 8
  • ✕Any current psychiatric disorder (DSM-5) other than AUD that might require intervention during study
  • ✕Currently receiving psychotropic medication
  • ✕Moderate-to-severe alcohol withdrawal (CIWA-Ar >13)
  • ✕History of alcohol withdrawal seizures or delirium

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03256253
NCT03256253Phase 2Completed
CompareCT.gov

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

New York State Psychiatric Institute·interventional·Posted Aug 21, 2017·Updated Aug 31, 2020

In Brief

A Phase 2 clinical trial evaluating Pregabalin for Alcohol Use Disorder. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Use Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 21, 2017
Enrollment StartFeb 15, 2018
Primary CompletionMay 31, 2019
Study CompletionMay 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.9 years ago

Interventions

Pregabalindrug

pregabalin up to 600 mg/day