NCT04322305

Pregabalin Trial for the Treatment of Alcohol Use Disorder

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

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Pregabalin	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.
OTHER	Placebo	Placebo capsules will be provided twice daily over 8 weeks and one week taper..

Timeline

• Start date: 2021-01-11
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2020-03-26
• Last updated: 2025-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study