Pregabalin for Alcohol Dependence

April 4, 2020 updated by: St. Petersburg Bekhterev Research Psychoneurological Institute

Double Blind Placebo Controlled Randomized Clinical Trial of Pregabalin for Alcohol Dependence

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • St.-Petersburg, Russian Federation, 192019
        • St.-Petersburg Bekhterev Reserach Psychoneurological Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Alcohol Dependence by ICD-X criteria

Exclusion Criteria:

  • Severe co-morbid psychiatric and somatic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: pregabalin
Drug: Pregabalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention in treatment
Time Frame: three months
Number of subjects retianed in treatment (not relapsed)
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weekly alcohol consumption
Time Frame: three months
Time Line Follow Back technique
three months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: three months
Hamilton anxiety scale and Spielbereger State Trait Anxiety test
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Petersburg Bekhterev Research Psychoneurological Institute

Collaborators

St.-Petersburg Bekhterev Research Psychoneurological Institute, Russian Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

July 30, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimate)

July 31, 2014

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 4, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRPI-PGBL-A01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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