Interest of tDCS in Help for Supporting Alcohol Abstinence (ITAMAA)

January 12, 2026 updated by: Centre Hospitalier Henri Laborit
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study takes place at one site (Henri Laborit Hospital, Poitiers, France) and is comparative, randomized and controlled.

There are 2 groups : one group is receiving sessions of active tDCS (active group) whereas the second group is receiving sham (placebo) sessions (control group).

Patients are randomized either in the active group or in the control group with a 1:1 ratio.

An unblinded investigator is responsible of the stimulation part and could not evaluate the patients. The other investigators are blinded and could evaluate the patients.

The study is going to evaluate the effect produces by stimulations in the two groups.

In the placebo group, after the intensity has reached its maximal intensity (the same as in the active group), the stimulation is stopped after few seconds (30 seconds in mostly studies). This process allow patients in the placebo group to feel the same sensations as patients in the active group (indeed, tingles and itches are felt only during the first few seconds of stimulation). The poor duration of stimulation do not produces clinical effect.

The study begins after a withdrawal period of 7 days +/- 3 days with 10 stimulations of 2 mA during 20 minutes from Monday to Friday during 2 weeks.

Following these stimulation sessions, the patient will have 5 follow-up visits on site with an investigator and 2 phone follow-up.

Visits:

  • Pre-inclusion visit
  • V0 visit (inclusion visit): takes place at the earliest 48 hours after stopping benzodiazepines used in the withdrawal period.
  • Treatment (weeks 0 and 1): 5 days of treatment per week during 2 weeks 2 arms : sham (placebo, 10 stimulations) vs active (10 stimulations of 2 mA)
  • Visit 1 (Week 4) : short nurse consultation
  • Visit 2 (Week 6) : short medical consultation
  • Visit 3 (Week 10) : short medical consultation
  • Visit 4 (Week 14) : long medical consultation
  • Visit 5 (Week 18) : nurse phone follow-up
  • Visit 6 (Week 22) : nurse phone follow-up
  • Visit 7 (Week 26) : long medical consultation

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Poitiers, France
        • Centre Hospitalier Henri Laborit
      • Thouars, France
        • Centre Hospitalier Nord-Deux-Sèvres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active tDCS stimulations
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
20 min, 2mA
Sham Comparator: Sham tDCS

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
20 min, Sham

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Alcohol Abstinence
Time Frame: 3 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relapse control
Time Frame: 6 months
Evaluation of tDCS interest in help for relapse control.
6 months
Alcohol consumption
Time Frame: 6 months
Impact on alcohol consumption based on the Total Alcohol Consumption (TAC).
6 months
Anxiety-depression
Time Frame: 6 months
Impact on the anxiety-depression symptomatology
6 months
Tobacco consumption
Time Frame: 6 months
Impact on tobacco consumption (decrease of cigarette consumption).
6 months
Safety assessment with adverse and/or intercurrent events analysis.
Time Frame: 6 months
The clinical tolerability will be objectified through the analysis of adverse and /or intercurrent events occuring all along the study. Theses events will be assessed at every study visit during patient examination.
6 months
Cognitive functions assessments with the Moca-test questionnaire.
Time Frame: 6 months
The score to the Moca-test will permit to assessed the cognitive functions from baseline (week 0) to the week 14 and from baseline from the week 26.
6 months
Executive functions assessments with the scale Barratt Impulsiveness Scale (BIS 11).
Time Frame: 6 months
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
6 months
Executive functions assessments with the Go NoGo task.
Time Frame: 6 months
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
6 months
Executive functions assessments with the Wisconsin Card Sorting Test (WCST).
Time Frame: 6 months
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
6 months
Executive functions assessments with the Stroop test.
Time Frame: 6 months
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
6 months
Executive functions assessments with the IOWA Gambling Task (IGT).
Time Frame: 6 months
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Henri Laborit

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nematollah Jaafari, Professor, Centre Hospitalier Henri Laborit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-A00304-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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