tDCS to Prevent Relapse in Alcohol Use Disorder

NCT04990375 | Completed

• 1 other identifier: tDCS in AUD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Active tDCS; Sham tDCS

Keywords

tDCS; DLPFC; Alcohol use disorder; Relapse; Craving

Outcome Measures

Primary Outcomes (3)

• Relapse rate 2 weeks after discharge

  by phone call; more than 60 g of alcohol

  2-week follow-up

• Relapse rate 1 month after discharge

  by phone call; more than 60 g of alcohol

  1-month follow-up

• Relapse rate 3 months after discharge

  by phone call; more than 60 g of alcohol

  3-month follow-up

Secondary Outcomes (8)

• Craving

  at pre-intervention (day 12 of hospitalization)

• Craving

  at post-intervention (day 22 of hospitalization)

• Working memory

  at pre-intervention (day 12 of hospitalization)

• Working memory

  at post-intervention (day 22 of hospitalization)

• Depressive symptoms

  at pre-intervention (day 12 of hospitalization)

Study Arms (4)

Early relapse (2-week follow-up)

SHAM COMPARATOR

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.

Device: tDCS

Craving

EXPERIMENTAL

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.

Device: tDCS

Working memory

EXPERIMENTAL

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.

Device: tDCS

Depressive symptoms

EXPERIMENTAL

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.

Device: tDCS

Interventions

tDCS DEVICE

5 sessions of 20-minute tDCS at 2 mA over the dorsolateral prefrontal cortex (35cm² sponge)

Craving; Depressive symptoms; Early relapse (2-week follow-up); Working memory

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• French speaker
• Severe Alcohol Use Disorder requiring alcohol rehabilitation
• Desire to stay sober for at least the next six months

You may not qualify if:

• 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

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU-Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Alcoholism; Recurrence

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Dubuson Macha, MA

  Université Libre de Bruxelles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: sham tDCS protocol: 0 mA but 30s of 2 mA at the start and the end of the session
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: active tDCS vs. sham tDCS, while the patient is watching a documentary

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 4, 2021
• Study Start: April 2, 2021
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

BE (1)