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NCT02205879 Clinical Trial

Pregabalin for Alcohol Dependence

Alcoholism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02205879
Other study ID # BRPI-PGBL-A01
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2013
Est. completion date December 2019

Study information
Verified date April 2020
Source St. Petersburg Bekhterev Research Psychoneurological Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- Alcohol Dependence by ICD-X criteria

Exclusion Criteria:

- Severe co-morbid psychiatric and somatic diseases

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pregabalin

• Placebo

Locations
Country Name City State
Russian Federation St.-Petersburg Bekhterev Reserach Psychoneurological Institute St.-Petersburg

Sponsors (2)
Lead Sponsor Collaborator
St. Petersburg Bekhterev Research Psychoneurological Institute St.-Petersburg Bekhterev Research Psychoneurological Institute, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Other Anxiety Hamilton anxiety scale and Spielbereger State Trait Anxiety test three months
Primary Retention in treatment Number of subjects retianed in treatment (not relapsed) three months
Secondary Weekly alcohol consumption Time Line Follow Back technique three months
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