CHU-Brugmann
Brussels, 1020, Belgium
NCT Number: NCT04990375
Despite the system of care in place, patients suffering from an alcohol use disorder (AUD) continue to relapse after their detoxification. For about twenty years, neuromodulations and their mechanisms have been investigated in research in order to apply it as a therapeutic means, in particular direct current transcranial stimulation (tDCS). A previous study found a reduction of relapse rate thanks to the tDCS over the dorsolateral prefrontal cortex (DLPFC; anode on the right and cathode on the left) combined with an ICT.
This clinical trial of 5 sessions of tDCS alone on the DLPFC (20 minutes, anode on the right, cathode on the left). This study follows the same tDCS configuration as the previous one and takes place in the same multidisciplinary detoxification framework in order to see the relevance of using combined tDCS or only tDCS in clinical practice.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Brussels, 1020, Belgium
Hypotheses: For patients with AUD five sessions of tDCS during a detoxification:
Context: This is a clinical trial that is part of an alcohol detoxification cure at Unit 72 Addictology of CHU Brugmann. The idea is to add a neuromodulation intervention to the initial management, multidisciplinary and psycho-bio-social. This will be a randomized, sham-controlled, single-blind study.
A total of 60 subjects will be recruited according to the inclusion and exclusion criteria. They will be randomly divided into two groups: the 'active' group (A) that will benefit from tDCS stimulation and the 'sham' group (S).
Measures:
Primary dependent variables :
Relapse and total abstinence measured at several defined times: two weeks, one month, three months, six months and one year after treatment.
Secondary dependent variables:
All the questionnaires were in French version.
Metacognition items: At the end of the experiment, patients will be asked orally (1) Do you think you are in the active tDCS group?, (2) Would you be interested in continuing this intervention over a longer period of time?
Statistical analyses:
Primary measurement: In order to respond to our primary assumptions about relapse, a logistic regressions will be performed with the independent variable conditions (tDCS active scored 1 and tDCS sham scored -1) and the variable dependent relapse at each measurement (2 weeks, 1 month, 3 months, 6 months and 1 year). A Kaplan-Meier survival analysis will be performed on the number of days prior to relapse to compare the curves up to one year of follow-up.
Secondary measures: In order to respond to our secondary assumptions about the variables before and after the intervention, mixed repeated measures ANOVAs [Time (T1 vs. T2) x Condition (tDCS active vs. tDCS sham)] will be performed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 sessions of 20-minute tDCS at 2 mA over the dorsolateral prefrontal cortex (35cm² sponge)
Time frame: 2-week follow-up
by phone call; more than 60 g of alcohol
Time frame: 1-month follow-up
by phone call; more than 60 g of alcohol
Time frame: 3-month follow-up
by phone call; more than 60 g of alcohol
Time frame: at pre-intervention (day 12 of hospitalization)
Visual Analog Scales (4 items, range 1-9 each; 1 = no craving, 9 = extreme craving)
Time frame: at post-intervention (day 22 of hospitalization)
Visual Analog Scales (4 items, range 1-9 each; 1 = no craving, 9 = extreme craving)
Time frame: at pre-intervention (day 12 of hospitalization)
Reverse memory span, range 2-9
Time frame: at post-intervention (day 22 of hospitalization)
Reverse memory span, range 2-9
Time frame: at pre-intervention (day 12 of hospitalization)
Beck Depression Inventory II (BDI-II) [44], which assessed the severity of depressive symptoms (21 items; range, 0-63; 10-18 = mild depression, 19-29 = moderate depression, 30-63 = severe depression)
Time frame: at post-intervention (day 22 of hospitalization)
Beck Depression Inventory II (BDI-II) [44], which assessed the severity of depressive symptoms (21 items; range, 0-63; 10-18 = mild depression, 19-29 = moderate depression, 30-63 = severe depression)
Time frame: at pre-intervention (day 12 of hospitalization)
The State-Trait Anxiety Inventory (STAI-Y) A which assessed the anxiety state (20 items; range, 20-80; < 35 = very low anxiety state, 36-45 = low anxiety state, 46-55 = medium anxiety state, 56-65 = high anxiety state, >65 = very high anxiety state).
Time frame: at post-intervention (day 22 of hospitalization)
The State-Trait Anxiety Inventory (STAI-Y) A which assessed the anxiety state (20 items; range, 20-80; < 35 = very low anxiety state, 36-45 = low anxiety state, 46-55 = medium anxiety state, 56-65 = high anxiety state, >65 = very high anxiety state).
Brugmann University Hospital
Other
Placebo-controlled Randomized Clinical Trial: tDCS to Prevent Relapse in Alcohol Use Disorder
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