NCT02205879

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

6.9 years

First QC Date

July 30, 2014

Last Update Submit

April 4, 2020

Conditions

Alcoholism

Keywords

pregabalinpatientstreatment

Outcome Measures

Primary Outcomes (1)

  • Retention in treatment

    Number of subjects retianed in treatment (not relapsed)

    three months

Secondary Outcomes (1)

  • Weekly alcohol consumption

    three months

Other Outcomes (1)

  • Anxiety

    three months

Study Arms (2)

pregabalin

EXPERIMENTAL
Drug: Pregabalin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PregabalinDRUG
pregabalin
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Alcohol Dependence by ICD-X criteria

You may not qualify if:

  • Severe co-morbid psychiatric and somatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St.-Petersburg Bekhterev Reserach Psychoneurological Institute

Saint Petersburg, 192019, Russia

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2014

First Posted

July 31, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations

RU(1)