NCT03256253

Pregabalin as Treatment for Alcohol Use Disorder

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

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

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.

Detailed description

The proposed protocol is an open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. Pregabalin is commonly used for the treatment of pain issues such as fibromyalgia (chronic pain in your body), diabetic nerve pain, spinal cord injury nerve, and pain after shingles. We plan to enroll 20 participants in an 8-week trial.The ideal dosing, tolerability, and safety of pregabalin will be tested in outpatients with Alcohol Use Disorder (AUD). The primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Pregabalin	pregabalin up to 600 mg/day

Timeline

• Start date: 2018-02-15
• Primary completion: 2019-05-31
• Completion: 2020-05-31
• First posted: 2017-08-21
• Last updated: 2020-08-31
• Results posted: 2020-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study