Pregabalin for Alcohol Dependence

Phase 4

Completed

• Conditions: Alcoholism
• Interventions: Drug: Placebo; Drug: Pregabalin

• Registration Number: NCT02205879
• Lead Sponsor: St. Petersburg Bekhterev Research Psychoneurological Institute

Brief Summary

The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking and reducing drinking severity

Detailed Description

This is a two cell double blind placebo controlled randomized clinical trial of pregabalin for alcohol dependence

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-07-30
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-04
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Alcohol Dependence by ICD-X criteria

Exclusion Criteria

• Severe co-morbid psychiatric and somatic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
pregabalin	Pregabalin	-

Primary Outcome Measures

Name	Time	Method
Retention in treatment	three months	Number of subjects retianed in treatment (not relapsed)

Secondary Outcome Measures

Name	Time	Method
Weekly alcohol consumption	three months	Time Line Follow Back technique

Trial Locations

Locations (1)

St.-Petersburg Bekhterev Reserach Psychoneurological Institute; 🇷🇺 St.-Petersburg, Russian Federation