Placebo-controlled Randomized Clinical Trial: tDCS to Prevent Relapse in Alcohol Use Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brugmann University Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Relapse rate 1 month after discharge
Study Overview
Brief Summary
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.
Detailed Description
Hypotheses: For patients with AUD five sessions of tDCS during a detoxification:
- decrease the relapse rate 2 weeks after the treatment;
- decrease patient craving;
- decrease depression and anxiety symptoms;
- strengthen working memory performances.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
sham tDCS protocol: 0 mA but 30s of 2 mA at the start and the end of the session
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •French speaker
- •Severe Alcohol Use Disorder requiring alcohol rehabilitation
- •Desire to stay sober for at least the next six months
Exclusion Criteria
- •Neurological history (epilepsy, head injury, and stroke)
- •Mental confusion or severe cognitive impairment
- •Schizophrenia, chronic psychotic disorders or bipolar type 1 disorder
- •Metal in the brain
- •Pregnancy
- •Having participated in our previous study combining tDCS with ICT
Arms & Interventions
Early relapse (2-week follow-up)
We compare 5 sessions of active tDCS (2 mA) vs. 5 sessions of sham tDCS (0 mA) to observe if tDCS can reduce early relapse (2-week follow-up). The tDCS is applied during 20 minutes while the patient is watching a documentary about nature. For both active and sham tDCS there is 15-second ramping up and down.
Intervention: tDCS (Device)
Craving
We compare scored craving before and after 5 sessions of either active (2mA) or sham (0mA) tDCS. The tDCS is applied during 20 minutes while the patient is watching a documentary about nature. For both active and sham tDCS there is 15-second ramping up and down.
Intervention: tDCS (Device)
Working memory
We compare reverse memory span before and after 5 sessions of either active (2mA) or sham (0mA) tDCS. The tDCS is applied during 20 minutes while the patient is watching a documentary about nature. For both active and sham tDCS there is 15-second ramping up and down.
Intervention: tDCS (Device)
Depressive symptoms
We compare scored BDI-II before and after 5 sessions of either active (2mA) or sham (0mA) tDCS. The tDCS is applied during 20 minutes while the patient is watching a documentary about nature. For both active and sham tDCS there is 15-second ramping up and down.
Intervention: tDCS (Device)
Outcomes
Primary Outcomes
Relapse rate 1 month after discharge
Time Frame: 1-month follow-up
by phone call; more than 60 g of alcohol
Relapse rate 3 months after discharge
Time Frame: 3-month follow-up
by phone call; more than 60 g of alcohol
Relapse rate 2 weeks after discharge
Time Frame: 2-week follow-up
by phone call; more than 60 g of alcohol
Secondary Outcomes
- Working memory(at post-intervention (day 22 of hospitalization))
- Craving(at post-intervention (day 22 of hospitalization))
- Depressive symptoms(at post-intervention (day 22 of hospitalization))
- Anxiety state(at post-intervention (day 22 of hospitalization))
- Craving(at pre-intervention (day 12 of hospitalization))
- Working memory(at pre-intervention (day 12 of hospitalization))
- Depressive symptoms(at pre-intervention (day 12 of hospitalization))
- Anxiety state(at pre-intervention (day 12 of hospitalization))
Investigators
Macha Dubuson
Principal Investigator
Brugmann University Hospital