Overview

This trial is active, not recruiting.

Condition alcoholism
Treatments pregabalin, placebo
Phase phase 4
Sponsor St. Petersburg Bekhterev Research Psychoneurological Institute
Collaborator St.-Petersburg Bekhterev Research Psychoneurological Institute, Russian Federation
Start date January 2013
End date December 2016
Trial size 100 participants
Trial identifier NCT02205879, BRPI-PGBL-A01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
pregabalin
(Placebo Comparator)
placebo

Primary Outcomes

Measure
Retention in treatment
time frame: three months

Secondary Outcomes

Measure
Weekly alcohol consumption
time frame: three months

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

Inclusion Criteria: - Alcohol Dependence by ICD-X criteria Exclusion Criteria: - Severe co-morbid psychiatric and somatic diseases

Additional Information

Official title Double Blind Placebo Controlled Randomized Clinical Trial of Pregabalin for Alcohol Dependence
Description This is a two cell double blind placebo controlled randomized clinical trial of pregabalin for alcohol dependence
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by St. Petersburg Bekhterev Research Psychoneurological Institute.