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Completed

NCT Number: NCT04990375

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU-Brugmann

Brussels, 1020, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Device

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

Primary outcomes

  1. Relapse rate 2 weeks after discharge

    Time frame: 2-week follow-up

    by phone call; more than 60 g of alcohol

  2. Relapse rate 1 month after discharge

    Time frame: 1-month follow-up

    by phone call; more than 60 g of alcohol

  3. Relapse rate 3 months after discharge

    Time frame: 3-month follow-up

    by phone call; more than 60 g of alcohol

Secondary outcomes

  1. Craving

    Time frame: at pre-intervention (day 12 of hospitalization)

    Visual Analog Scales (4 items, range 1-9 each; 1 = no craving, 9 = extreme craving)

  2. 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)

  3. Working memory

    Time frame: at pre-intervention (day 12 of hospitalization)

    Reverse memory span, range 2-9

  4. Working memory

    Time frame: at post-intervention (day 22 of hospitalization)

    Reverse memory span, range 2-9

  5. Depressive symptoms

    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)

  6. Depressive symptoms

    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)

  7. Anxiety state

    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).

  8. 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).

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 4, 2021
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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