Alcoholic IntoxicationITAMAANCT03287154
Interest of tDCS in Help for Supporting Alcohol Abstinence
A study testing Active tDCS stimulations in people with Alcoholic Intoxication, run by Centre Hospitalier Henri Laborit at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholic Intoxication
- What is being tested?
- Active tDCS stimulations
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Feb 2017to 7 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Henri Laborit
Poitiers
Centre Hospitalier Nord-Deux-Sèvres
Thouars
About this study
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.
Read the 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
- Conditions
- Alcoholic Intoxication
- Being tested
- Active tDCS stimulations, Sham tDCS
- Keywords
- Alcohol Abstinence, Alcohol Addiction, Alcohol Consumption, Alcohol Dependence
- Medical subject headings
- Alcoholic Intoxication, Alcohol Abstinence, Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCS stimulationsDevice
20 min, 2mA
Sham tDCSDevice
20 min, Sham
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (11)
Relapse control
Evaluation of tDCS interest in help for relapse control.
Measured: 6 months
Alcohol consumption
Impact on alcohol consumption based on the Total Alcohol Consumption (TAC).
Measured: 6 months
Anxiety-depression
Impact on the anxiety-depression symptomatology
Measured: 6 months
Tobacco consumption
Impact on tobacco consumption (decrease of cigarette consumption).
Measured: 6 months
Safety assessment with adverse and/or intercurrent events analysis.
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.
Measured: 6 months
Cognitive functions assessments with the Moca-test questionnaire.
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.
Measured: 6 months
Executive functions assessments with the scale Barratt Impulsiveness Scale (BIS 11).
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
Measured: 6 months
Executive functions assessments with the Go NoGo task.
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
Measured: 6 months
Executive functions assessments with the Wisconsin Card Sorting Test (WCST).
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
Measured: 6 months
Executive functions assessments with the Stroop test.
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
Measured: 6 months
Executive functions assessments with the IOWA Gambling Task (IGT).
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start8 Feb 2017
- Primary completion7 Feb 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic IntoxicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nematollah Jaafari, Professor, Principal investigator, Centre Hospitalier Henri Laborit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287154
- Sponsor's protocol ID
- 2016-A00304-47
- Acronym
- ITAMAA
- Status last verified
- Jun 2025
- First submitted
- 7 Sep 2017
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of tDCS in Help for Supporting Alcohol Abstinence
- ClinicalTrials.gov ID
- NCT03287154
- Acronym / sponsor ID
- ITAMAA / 2016-A00304-47
- Conditions
- Alcoholic Intoxication
- Keywords
- Alcohol Abstinence, Alcohol Addiction, Alcohol Consumption, Alcohol Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Centre Hospitalier Henri LaboritUniversity, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS stimulations | Experimental | Device: Active tDCS stimulationsPatients in this arm will receive 10 tDCS active stimulations of 2 mA (1 stimulation per day from Monday to Friday during 2 weeks). |
| Sham tDCS | Sham comparator | Device: Sham tDCSPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCS stimulations20 min, 2mA | Device | Active tDCS stimulations |
| Sham tDCS20 min, Sham | Device | Sham tDCS |
Primary outcome
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.
11 secondary outcomes
Relapse control
Time frame: 6 months
Alcohol consumption
Time frame: 6 months
Anxiety-depression
Time frame: 6 months
Tobacco consumption
Time frame: 6 months
Safety assessment with adverse and/or intercurrent events analysis.
Time frame: 6 months
Cognitive functions assessments with the Moca-test questionnaire.
Time frame: 6 months
Executive functions assessments with the scale Barratt Impulsiveness Scale (BIS 11).
Time frame: 6 months
Executive functions assessments with the Go NoGo task.
Time frame: 6 months
Executive functions assessments with the Wisconsin Card Sorting Test (WCST).
Time frame: 6 months
Executive functions assessments with the Stroop test.
Time frame: 6 months
Executive functions assessments with the IOWA Gambling Task (IGT).
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nematollah Jaafari, Professor principal investigator
Centre Hospitalier Henri Laborit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS stimulations in people with Alcoholic Intoxication, run by Centre Hospitalier Henri Laborit at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Abstinence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.