Interest of tDCS in Help for Supporting Alcohol Abstinence (ITAMAA)
Primary Purpose
Alcoholic Intoxication
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Active tDCS stimulations
Sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholic Intoxication focused on measuring Alcohol Abstinence, Alcohol Addiction, Alcohol Consumption, Alcohol Dependence
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
Sites / Locations
- Centre Hospitalier Henri LaboritRecruiting
- Centre Hospitalier Nord-Deux-SèvresRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active tDCS stimulations
Sham tDCS
Arm Description
Patients in this arm will receive 10 tDCS active stimulations of 2 mA (1 stimulation per day from Monday to Friday during 2 weeks).
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Relapse control
Evaluation of tDCS interest in help for relapse control.
Alcohol consumption
Impact on alcohol consumption based on the Total Alcohol Consumption (TAC).
Anxiety-depression
Impact on the anxiety-depression symptomatology
Tobacco consumption
Impact on tobacco consumption (decrease of cigarette consumption).
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03287154
First Posted
September 7, 2017
Last Updated
August 2, 2023
Sponsor
Centre Hospitalier Henri Laborit
1. Study Identification
Unique Protocol Identification Number
NCT03287154
Brief Title
Interest of tDCS in Help for Supporting Alcohol Abstinence
Acronym
ITAMAA
Official Title
Interest of tDCS in Help for Supporting Alcohol Abstinence
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2017 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Laborit
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Intoxication
Keywords
Alcohol Abstinence, Alcohol Addiction, Alcohol Consumption, Alcohol Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS stimulations
Arm Type
Experimental
Arm Description
Patients in this arm will receive 10 tDCS active stimulations of 2 mA (1 stimulation per day from Monday to Friday during 2 weeks).
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active tDCS stimulations
Intervention Description
20 min, 2mA
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
20 min, Sham
Primary Outcome Measure Information:
Title
Alcohol Abstinence
Description
The primary outcome is to evaluate the interest of the transcranial Direct Current Stimulation (tDCS) for helping the abstinence support in addictive alcoholic patients.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Relapse control
Description
Evaluation of tDCS interest in help for relapse control.
Time Frame
6 months
Title
Alcohol consumption
Description
Impact on alcohol consumption based on the Total Alcohol Consumption (TAC).
Time Frame
6 months
Title
Anxiety-depression
Description
Impact on the anxiety-depression symptomatology
Time Frame
6 months
Title
Tobacco consumption
Description
Impact on tobacco consumption (decrease of cigarette consumption).
Time Frame
6 months
Title
Safety assessment with adverse and/or intercurrent events analysis.
Description
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.
Time Frame
6 months
Title
Cognitive functions assessments with the Moca-test questionnaire.
Description
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.
Time Frame
6 months
Title
Executive functions assessments with the scale Barratt Impulsiveness Scale (BIS 11).
Description
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
Time Frame
6 months
Title
Executive functions assessments with the Go NoGo task.
Description
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
Time Frame
6 months
Title
Executive functions assessments with the Wisconsin Card Sorting Test (WCST).
Description
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
Time Frame
6 months
Title
Executive functions assessments with the Stroop test.
Description
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
Time Frame
6 months
Title
Executive functions assessments with the IOWA Gambling Task (IGT).
Description
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nematollah Jaafari, Professor
Phone
0033 5 16 52 61 18
Email
nemat.jaafari@ch-poitiers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nematollah Jaafari, Professor
Organizational Affiliation
Centre Hospitalier Henri Laborit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nematollah Jaafari, Professor
Phone
0033 5 16 52 61 18
Email
nemat.jaafari@ch-poitiers.fr
Facility Name
Centre Hospitalier Nord-Deux-Sèvres
City
Thouars
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Issa Wassouf, Doctor
Email
wassouf.issa@chnds.fr
First Name & Middle Initial & Last Name & Degree
Issa Wassouf, Doctor
12. IPD Sharing Statement
Plan to Share IPD
No
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Interest of tDCS in Help for Supporting Alcohol Abstinence
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