## Protocol Section
### Identification Module
**NCT ID:** NCT02205879

**Brief Title:** Pregabalin for Alcohol Dependence

**Official Title:** Double Blind Placebo Controlled Randomized Clinical Trial of Pregabalin for Alcohol Dependence

#### Organization Study ID Info
**ID:** BRPI-PGBL-A01
#### Organization
**Class:** OTHER
**Full Name:** St. Petersburg Bekhterev Research Psychoneurological Institute
### Status Module
#### Completion Date
**Date:** 2019-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-04-07

**Type:** ACTUAL

**Last Update Submit Date:** 2020-04-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-12

**Type:** ACTUAL

#### Start Date
**Date:** 2013-01

**Type:** ACTUAL

**Status Verified Date:** 2020-04

#### Study First Post Date
**Date:** 2014-07-31
**Type:** ESTIMATED
**Study First Submit Date:** 2014-07-30
**Study First Submit QC Date:** 2014-07-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** St.-Petersburg Bekhterev Research Psychoneurological Institute, Russian Federation

#### Lead Sponsor

**Class:** OTHER

**Name:** St. Petersburg Bekhterev Research Psychoneurological Institute

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Alcoholism

**Keywords:**

- pregabalin

- patients

- treatment

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Pregabalin

**Label:** pregabalin

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- pregabalin

**Name:** Pregabalin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** Hamilton anxiety scale and Spielbereger State Trait Anxiety test

**Measure:** Anxiety

**Time Frame:** three months

#### Primary Outcomes

**Description:** Number of subjects retianed in treatment (not relapsed)

**Measure:** Retention in treatment

**Time Frame:** three months

#### Secondary Outcomes

**Description:** Time Line Follow Back technique

**Measure:** Weekly alcohol consumption

**Time Frame:** three months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Alcohol Dependence by ICD-X criteria

Exclusion Criteria:

* Severe co-morbid psychiatric and somatic diseases

**Maximum Age:** 60 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** St.-Petersburg

**Country:** Russian Federation

**Facility:** St.-Petersburg Bekhterev Reserach Psychoneurological Institute

**Zip:** 192019

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019973

- Term: Alcohol-Related Disorders

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3783

- Name: Alcoholism

- Relevance: HIGH

- As Found: Alcoholism

- ID: M21842

- Name: Alcohol-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000437

- Term: Alcoholism

### Intervention Browse Module - Ancestors

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000927

- Term: Anticonvulsants

- ID: D000002121

- Term: Calcium Channel Blockers

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000077264

- Term: Calcium-Regulating Hormones and Agents

- ID: D000014151

- Term: Anti-Anxiety Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000011619

- Term: Psychotropic Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: Analg

- Name: Analgesics

- Abbrev: AntiConv

- Name: Anticonvulsants

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

### Intervention Browse Module - Browse Leaves

- ID: M476

- Name: Pregabalin

- Relevance: HIGH

- As Found: Stage IV

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4246

- Name: Anticonvulsants

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5384

- Name: Calcium Channel Blockers

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M16905

- Name: Anti-Anxiety Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069583

- Term: Pregabalin

### Misc Info Module

- Version Holder: 2024-05-24
