Pregabalin for Alcohol Dependence

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02205879

Enrollment

100

Registered

2014-07-31

Start date

2013-01-31

Completion date

2019-12-31

Last updated

2020-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism

Keywords

pregabalin, patients, treatment

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

Interventions

DRUGPregabalin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Alcohol Dependence by ICD-X criteria

Exclusion criteria

* Severe co-morbid psychiatric and somatic diseases

Design outcomes

Primary

Measure	Time frame	Description
Retention in treatment	three months	Number of subjects retianed in treatment (not relapsed)

Secondary

Measure	Time frame	Description
Weekly alcohol consumption	three months	Time Line Follow Back technique

Other

Measure	Time frame	Description
Anxiety	three months	Hamilton anxiety scale and Spielbereger State Trait Anxiety test

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026