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OpenTrials
Completed

NCT Number: NCT02205879

Pregabalin for Alcohol Dependence

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

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St.-Petersburg Bekhterev Reserach Psychoneurological Institute

Saint Petersburg, 192019, Russia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Alcohol Dependence by ICD-X criteria

Exclusion criteria

  • Severe co-morbid psychiatric and somatic diseases

Treatment and study plan

Pregabalin

Drug

Placebo

Drug

Primary outcomes

  1. Retention in treatment

    Time frame: three months

    Number of subjects retianed in treatment (not relapsed)

Secondary outcomes

  1. Weekly alcohol consumption

    Time frame: three months

    Time Line Follow Back technique

Other outcomes

  1. Anxiety

    Time frame: three months

    Hamilton anxiety scale and Spielbereger State Trait Anxiety test

Sponsors and collaborators

Lead sponsor

St. Petersburg Bekhterev Research Psychoneurological Institute

Other

Collaborators

  • St.-Petersburg Bekhterev Research Psychoneurological Institute, Russian Federation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2014
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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