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Pregabalin for Alcohol Dependence

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ClinicalTrials.gov Identifier: NCT02205879
Recruitment Status : Unknown
Verified April 2016 by St. Petersburg Bekhterev Research Psychoneurological Institute.
Recruitment status was:  Active, not recruiting
First Posted : July 31, 2014
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
St.-Petersburg Bekhterev Research Psychoneurological Institute, Russian Federation
Information provided by (Responsible Party):
St. Petersburg Bekhterev Research Psychoneurological Institute

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

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Pregabalin Drug: Placebo Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Placebo Controlled Randomized Clinical Trial of Pregabalin for Alcohol Dependence
Study Start Date : January 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: pregabalin Drug: Pregabalin
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Retention in treatment [ Time Frame: three months ]
    Number of subjects retianed in treatment (not relapsed)


Secondary Outcome Measures :
  1. Weekly alcohol consumption [ Time Frame: three months ]
    Time Line Follow Back technique


Other Outcome Measures:
  1. Anxiety [ Time Frame: three months ]
    Hamilton anxiety scale and Spielbereger State Trait Anxiety test



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alcohol Dependence by ICD-X criteria

Exclusion Criteria:

  • Severe co-morbid psychiatric and somatic diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205879


Locations
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Russian Federation
St.-Petersburg Bekhterev Reserach Psychoneurological Institute
St.-Petersburg, Russian Federation, 192019
Sponsors and Collaborators
St. Petersburg Bekhterev Research Psychoneurological Institute
St.-Petersburg Bekhterev Research Psychoneurological Institute, Russian Federation

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Responsible Party: St. Petersburg Bekhterev Research Psychoneurological Institute
ClinicalTrials.gov Identifier: NCT02205879     History of Changes
Other Study ID Numbers: BRPI-PGBL-A01
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2016

Keywords provided by St. Petersburg Bekhterev Research Psychoneurological Institute:
pregabalin
patients
treatment

Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs