tDCS to Prevent Relapse in Alcohol Use Disorder

Placebo-controlled Randomized Clinical Trial: tDCS to Prevent Relapse in Alcohol Use Disorder

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.

Study Overview

• Status: Completed
• Conditions: Active tDCS; Sham tDCS
• Intervention / Treatment: Device: tDCS

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:

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:

• Craving measured before and after each tDCS session via visual analog scales, such as Likert 0 to 10. Craving will also be measured in T1 and T2 through the Craving Experience Questionnaire (CEQ);
• Symptoms of depression with the Beck Depression Inventory (BDI-II) and positive and negative affectivity with the Positive and Negative Affect Schedule (PANAS) measured at T1 and T2;
• Anxiety trait in T1 and T2 with the State Anxiety Inventory (STAI-A).
• The working memory performance measured in T1 and T2 with the span reversed.

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Chu-Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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.	Device: tDCS; 5 sessions of 20-minute tDCS at 2 mA over the dorsolateral prefrontal cortex (35cm² sponge)
Experimental: 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.	Device: tDCS; 5 sessions of 20-minute tDCS at 2 mA over the dorsolateral prefrontal cortex (35cm² sponge)
Experimental: 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.	Device: tDCS; 5 sessions of 20-minute tDCS at 2 mA over the dorsolateral prefrontal cortex (35cm² sponge)
Experimental: 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.	Device: tDCS; 5 sessions of 20-minute tDCS at 2 mA over the dorsolateral prefrontal cortex (35cm² sponge)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craving	Visual Analog Scales (4 items, range 1-9 each; 1 = no craving, 9 = extreme craving)	at pre-intervention (day 12 of hospitalization)
Craving	Visual Analog Scales (4 items, range 1-9 each; 1 = no craving, 9 = extreme craving)	at post-intervention (day 22 of hospitalization)
Working memory	Reverse memory span, range 2-9	at pre-intervention (day 12 of hospitalization)
Working memory	Reverse memory span, range 2-9	at post-intervention (day 22 of hospitalization)
Depressive symptoms	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)	at pre-intervention (day 12 of hospitalization)
Depressive symptoms	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)	at post-intervention (day 22 of hospitalization)
Anxiety state	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).	at pre-intervention (day 12 of hospitalization)
Anxiety state	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).	at post-intervention (day 22 of hospitalization)

Collaborators and Investigators

• Sponsor: Brugmann University Hospital
• Investigators: Principal Investigator: Dubuson Macha, MA, Université Libre de Bruxelles

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2021
• Primary Completion (Actual): June 6, 2022
• Study Completion (Actual): June 6, 2022

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: tDCS; Craving; Relapse; Alcohol use disorder; DLPFC
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Disease Attributes; Alcohol Drinking; Alcoholism; Recurrence
• Other Study ID Numbers: tDCS in AUD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No