Severe Alcohol-use Disorder: a tDCS and Response Inhibition Training Intervention
ALCOSTIM
Treating Alcohol Dependence : Testing a Combined Treatment Model Using Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Training (ICT)
1 other identifier
interventional
136
1 country
1
Brief Summary
Most severe forms of alcohol-use disorder are thought to reflect an abnormal interplay between two neural systems: an overly active impulsive one driven by immediate rewards prospects and a weak reflective one, tuned on long-term prospects. The investigators propose that two non-pharmacological interventions, Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Techniques (ICT) may act on both systems when combined, which might ultimately result is a reduction of alcohol relapse rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedFirst Posted
Study publicly available on registry
February 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedNovember 4, 2020
November 1, 2020
2.2 years
November 3, 2017
November 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Reduction of alcohol use in post-treatment at week 2
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
é weeks post-rehab
Reduction of alcohol use in post-treatment at week 4
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
4 weeks post-rehab
Reduction of the relapse rate in post-treatment at week 2
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
2 weeks post-rehab
Reduction of the relapse rate in post-treatment at week 4
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
4 weeks post-rehab
Reduction of alcohol use in post-treatment at week 12
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
12 weeks post-rehab
Reduction of the relapse rate in post-treatment at week 12
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
12 weeks post-rehab
Reduction of alcohol use in post-treatment at week 24
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
24 weeks post-rehab
Reduction of the relapse rate in post-treatment at week 24
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
24 weeks post-rehab
Secondary Outcomes (8)
Cue reactivity (attractiveness) at day 22
at post-intervention (day 22 of hospitalization)
Cue reactivity at day 22
at post-intervention (day 22 of hospitalization)
Cue reactivity (valence) at day 22
at post-intervention (day 22 of hospitalization)
Cue reactivity (arousal) at day 22
at post-intervention (day 22 of hospitalization)
Cue reactivity (alcohol verbal fluency) at day 12
at baseline (day 12 of hospitalization)
- +3 more secondary outcomes
Study Arms (4)
Combined TDCS active and ICT active
EXPERIMENTALFive 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 sham and ICT active
ACTIVE COMPARATORFive 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 TDCS active and ICT inactive
ACTIVE COMPARATORFive 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 Sham TDCS and inactive ICT
SHAM COMPARATORFive 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.
Interventions
Five 20-minute long sessions including TDCS (2 MicroAmperes during 20 minutes) and ICT, 5 consecutive days
Five 20-minute long sessions including TDCS sham (non active) and ICT, 5 consecutive days
Five 20-minute long sessions including TDCS sham and no-cue inhibition training, 5 consecutive days
Five 20-minute long sessions including TDCS and no-cue inhibition training, 5 consecutive days
Eligibility Criteria
You may qualify if:
- Patients with severe alcohol-use disorder (DSM-5 criteria), hospitalized for detoxification.
- 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
- Patients must be reachable for follow-up
You may not qualify if:
- Previous neurological conditions (epilepsy, traumatic brain injury, stroke)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brugmann University Hospitallead
- University Ghentcollaborator
- Université Libre de Bruxellescollaborator
Study Sites (1)
CHU-Brugmann
Brussels, ++32, Belgium
Related Publications (1)
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.
PMID: 34687964DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Associate at the F.R.S/FNRS
Study Record Dates
First Submitted
November 3, 2017
First Posted
February 27, 2018
Study Start
January 1, 2018
Primary Completion
March 18, 2020
Study Completion
September 1, 2020
Last Updated
November 4, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share