Severe Alcohol-use Disorder: a tDCS and Response Inhibition Training Intervention
NCT ID: NCT03447054
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2018-01-01
2020-09-01
Brief Summary
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Detailed Description
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The investigators will recruit 160 alcohol-dependent patients and divide them randomly between four treatment conditions : real transcranial Direct Current Stimulation (tDCS) with active or control Inhibitory Control Technique (ICT ); or sham (placebo) tDCS with active or control ICT.
Patients will be evaluated with primary outcome measures (alcohol consumption patterns) and secondary outcome measures (working memory and changes in alcohol-related stimuli affective values).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Combined TDCS active and ICT active
Five consecutive days: Twenty minutes of TDCS on the right dorsolateral prefrontal cortex while performing an alcohol-cue inhibitory control training consisting to systematically paired go responses with non-alcohol pictures and no-go responses with alcohol-related pictures.
Combined TDCS active and ICT active
Five 20-minute long sessions including TDCS (2 MicroAmperes during 20 minutes) and ICT, 5 consecutive days
Combined TDCS sham and ICT active
Five consecutive days: Twenty minutes of sham TDCS on the right dorsolateral prefrontal cortex, while performing a no-cue go/no-go training consisting to carry out a go/no-go paradigm with no alcohol-related content.
Combined Sham TDCS and inactive ICT
Five 20-minute long sessions including TDCS and no-cue inhibition training, 5 consecutive days
Combined TDCS active and ICT inactive
Five consecutive days: Twenty minutes of active TDCS in association with no-cue go/no-go training consisting to carry out a go/no-go paradigm with no alcohol-related content.
Combined TDCS active and ICT inactive
Five 20-minute long sessions including TDCS sham and no-cue inhibition training, 5 consecutive days
Combined Sham TDCS and inactive ICT
Five consecutive days: Twenty minutes of Inactive TDCS combined with an non alcohol-cue inhibitory control training consisting to carry out a go/no-go paradigm with no alcohol-related content.
Combined TDCS sham and ICT active
Five 20-minute long sessions including TDCS sham (non active) and ICT, 5 consecutive days
Interventions
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Combined TDCS active and ICT active
Five 20-minute long sessions including TDCS (2 MicroAmperes during 20 minutes) and ICT, 5 consecutive days
Combined TDCS sham and ICT active
Five 20-minute long sessions including TDCS sham (non active) and ICT, 5 consecutive days
Combined TDCS active and ICT inactive
Five 20-minute long sessions including TDCS sham and no-cue inhibition training, 5 consecutive days
Combined Sham TDCS and inactive ICT
Five 20-minute long sessions including TDCS and no-cue inhibition training, 5 consecutive days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Severity of alcohol use disorder must be at least moderate (at least 4 DSM-5 criteria)
* Aged between 18 and 65 years
* Comorbidity with anxiety disorders and depressive disorders is allowed
* Patients must be illegal drug free for 3 weeks at beginning of trial
* Pharmacotherapy: patients should be benzodiazepines free at the moment of inclusion. They are allowed to continue other psychotropic medication (antidepressants, antipsychotics, mood stabilizers), providing they are following a stable regimen that will not be changed during the protocol time.
* Patients must be reachable for follow-up
Exclusion Criteria
* Present delirium, confusion or severe cognitive disorder
* Schizophrenia, chronic psychotic disorders, bipolar type 1 disorder.
* Any severe, life-threatening disorders
* High suicidal risk
* Specific contraindications for tDCS: metallic plates in the head
* Alcohol medication treatment initiated during the rehab: acamprosate, disulfiram, baclofen, nalmefen.
18 Years
65 Years
ALL
No
Sponsors
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University Ghent
OTHER
Université Libre de Bruxelles
OTHER
Brugmann University Hospital
OTHER
Responsible Party
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Xavier NOËL
Research Associate at the F.R.S/FNRS
Locations
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CHU-Brugmann
Brussels, , Belgium
Countries
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References
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Dubuson M, Kornreich C, Vanderhasselt MA, Baeken C, Wyckmans F, Dousset C, Hanak C, Veeser J, Campanella S, Chatard A, Jaafari N, Noel X. Transcranial direct current stimulation combined with alcohol cue inhibitory control training reduces the risk of early alcohol relapse: A randomized placebo-controlled clinical trial. Brain Stimul. 2021 Nov-Dec;14(6):1531-1543. doi: 10.1016/j.brs.2021.10.386. Epub 2021 Oct 20.
Other Identifiers
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Baudoin_2016_J1130650_206500
Identifier Type: -
Identifier Source: org_study_id