NCT03287154

Brief Summary

The aim of the study is to evaluate in patients with alcohol disorder and forehand weaned the efficiency of 10 active tDCS sessions versus 10 sham (placebo) sessions in the support of abstinence at 3 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

February 8, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2025

Completed
Last Updated

January 13, 2026

Status Verified

June 1, 2025

Enrollment Period

8 years

First QC Date

September 7, 2017

Last Update Submit

January 12, 2026

Conditions

Alcoholic Intoxication

Keywords

Alcohol AbstinenceAlcohol AddictionAlcohol ConsumptionAlcohol Dependence

Outcome Measures

Primary Outcomes (1)

  • Alcohol Abstinence

    The primary outcome is to evaluate the interest of the transcranial Direct Current Stimulation (tDCS) for helping the abstinence support in addictive alcoholic patients.

    3 months

Secondary Outcomes (11)

  • Relapse control

    6 months

  • Alcohol consumption

    6 months

  • Anxiety-depression

    6 months

  • Tobacco consumption

    6 months

  • Safety assessment with adverse and/or intercurrent events analysis.

    6 months

  • +6 more secondary outcomes

Study Arms (2)

Active tDCS stimulations

EXPERIMENTAL

Patients in this arm will receive 10 tDCS active stimulations of 2 mA (1 stimulation per day from Monday to Friday during 2 weeks).

Device: Active tDCS stimulations

Sham tDCS

SHAM COMPARATOR

Patients in this arm will receive 10 sham stimulations (1 stimulation per day from Monday to Friday during 2 weeks). As soon as the power will have reached the maximal intensity as in the active arm, the stimulation will be stopped.

Device: Sham tDCS

Interventions

Active tDCS stimulationsDEVICE

20 min, 2mA

Active tDCS stimulations
Sham tDCSDEVICE

20 min, Sham

Sham tDCS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient aged from 18 to 70 years old
  • patient free, without guardianship
  • absence of epileptic pathology
  • patient affiliated to the french health security or benefiting through a third party
  • signed informed consent after having received a clear and honest information on the study.
  • patient with a disorder linked to the use of alcohol (define by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) classification) clinically evaluated.
  • patient requesting for an alcohol withdrawal
  • patient able to read and write

You may not qualify if:

  • patient not affiliated to the french health security or not benefiting through a third party
  • woman in reproductive capacity without effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intra-uterine device or chirurgical: tubal ligation, hysterectomy, total ovariectomy) or breastfeeding
  • patient hospitalized under duress
  • patient with guardianship
  • somatic complications during the alcohol withdrawal phase
  • current psychiatric decompensation (mood disorder, suicide risk, psychotic disorders).
  • patient under benzodiazepines treatment
  • patient with scalp cutaneous lesion
  • history of cranial traumatism
  • patient with intra-cerebral metallic object
  • patient with a pacemaker
  • epileptic pathology
  • patient in emergency condition or unable to give personally her/his consent
  • another dependence other than alcohol or tobacco
  • mental illness syndrome and Korsakoff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Henri Laborit

Poitiers, France

Location

Centre Hospitalier Nord-Deux-Sèvres

Thouars, France

Location

MeSH Terms

Conditions

Alcoholic IntoxicationAlcohol AbstinenceAlcoholismAlcohol Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

Study Officials

  • Nematollah Jaafari, Professor

    Centre Hospitalier Henri Laborit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 19, 2017

Study Start

February 8, 2017

Primary Completion

February 7, 2025

Study Completion

August 7, 2025

Last Updated

January 13, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)