Clinical trial NCT03287154: Interest of tDCS in Help for Supporting Alcohol Abstinence
Official title: Interest of tDCS in Help for Supporting Alcohol Abstinence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcoholic Intoxication
Keywords: Alcohol Abstinence
Alcohol Addiction
Alcohol Consumption
Alcohol Dependence
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Alcohol Abstinence
timeFrame: 3 months
Secondary outcomes:
measure: Relapse control
timeFrame: 6 months
measure: Alcohol consumption
timeFrame: 6 months
measure: Anxiety-depression
timeFrame: 6 months
measure: Tobacco consumption
timeFrame: 6 months
measure: Safety assessment with adverse and/or intercurrent events analysis.
timeFrame: 6 months
measure: Cognitive functions assessments with the Moca-test questionnaire.
timeFrame: 6 months
measure: Executive functions assessments with the scale Barratt Impulsiveness Scale (BIS 11).
timeFrame: 6 months
measure: Executive functions assessments with the Go NoGo task.
timeFrame: 6 months
measure: Executive functions assessments with the Wisconsin Card Sorting Test (WCST).
timeFrame: 6 months
measure: Executive functions assessments with the Stroop test.
timeFrame: 6 months
measure: Executive functions assessments with the IOWA Gambling Task (IGT).
timeFrame: 6 months
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
city: Thouars
country: France
facility: Centre Hospitalier Nord-Deux-Sèvres
Study officials:
affiliation: Centre Hospitalier Henri Laborit
name: Nematollah Jaafari, Professor
role: PRINCIPAL_INVESTIGATOR
References: