Pregabalin for Alcohol Dependence

NCT ID: NCT02205879

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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pregabalin

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Pregabalin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Alcohol Dependence by ICD-X criteria

Exclusion Criteria

* Severe co-morbid psychiatric and somatic diseases
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St.-Petersburg Bekhterev Research Psychoneurological Institute, Russian Federation

UNKNOWN

Sponsor Role collaborator

St. Petersburg Bekhterev Research Psychoneurological Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St.-Petersburg Bekhterev Reserach Psychoneurological Institute

Saint Petersburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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BRPI-PGBL-A01

Identifier Type: -

Identifier Source: org_study_id

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