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Pregabalin for Alcohol Dependence

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
St. Petersburg Bekhterev Research Psychoneurological Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring pregabalin, patients, treatment

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Alcohol Dependence by ICD-X criteria

Exclusion Criteria:

  • Severe co-morbid psychiatric and somatic diseases

Sites / Locations

  • St.-Petersburg Bekhterev Reserach Psychoneurological Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pregabalin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Retention in treatment
Number of subjects retianed in treatment (not relapsed)

Secondary Outcome Measures

Weekly alcohol consumption
Time Line Follow Back technique

Full Information

First Posted
July 30, 2014
Last Updated
April 4, 2020
Sponsor
St. Petersburg Bekhterev Research Psychoneurological Institute
Collaborators
St.-Petersburg Bekhterev Research Psychoneurological Institute, Russian Federation
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1. Study Identification

Unique Protocol Identification Number
NCT02205879
Brief Title
Pregabalin for Alcohol Dependence
Official Title
Double Blind Placebo Controlled Randomized Clinical Trial of Pregabalin for Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Petersburg Bekhterev Research Psychoneurological Institute
Collaborators
St.-Petersburg Bekhterev Research Psychoneurological Institute, Russian Federation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking and reducing drinking severity
Detailed Description
This is a two cell double blind placebo controlled randomized clinical trial of pregabalin for alcohol dependence

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
pregabalin, patients, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pregabalin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Retention in treatment
Description
Number of subjects retianed in treatment (not relapsed)
Time Frame
three months
Secondary Outcome Measure Information:
Title
Weekly alcohol consumption
Description
Time Line Follow Back technique
Time Frame
three months
Other Pre-specified Outcome Measures:
Title
Anxiety
Description
Hamilton anxiety scale and Spielbereger State Trait Anxiety test
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Alcohol Dependence by ICD-X criteria Exclusion Criteria: Severe co-morbid psychiatric and somatic diseases
Facility Information:
Facility Name
St.-Petersburg Bekhterev Reserach Psychoneurological Institute
City
St.-Petersburg
ZIP/Postal Code
192019
Country
Russian Federation

12. IPD Sharing Statement

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Pregabalin for Alcohol Dependence

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