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Completed

NCT Number: NCT03447054

Severe Alcohol-use Disorder: a tDCS and Response Inhibition Training Intervention

Most severe forms of alcohol-use disorder are thought to reflect an abnormal interplay between two neural systems: an overly active impulsive one driven by immediate rewards prospects and a weak reflective one, tuned on long-term prospects. The investigators propose that two non-pharmacological interventions, Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Techniques (ICT) may act on both systems when combined, which might ultimately result is a reduction of alcohol relapse rate.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Disease Attributes Inhibition, Psychological Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU-Brugmann

Brussels, ++32, Belgium

About this study

Treating Alcohol dependence remains notoriously difficult despite use of several medications, psychotherapeutic and psychosocial interventions. Alcohol dependence is thought to reflect an abnormal interplay between two neural systems: an overly active impulsive one driven by immediate rewards prospects and a weak reflective one, tuned on long-term prospects. The investigators proposes that two non-pharmacological interventions, Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Techniques (ICT) may act on both systems when combined. tDCS has been found to improve working memory, which is necessary to evaluate long-term consequences of actions. ICT is able to modify the automatic approach tendencies towards appetitive cues.

The investigators will recruit 160 alcohol-dependent patients and divide them randomly between four treatment conditions : real transcranial Direct Current Stimulation (tDCS) with active or control Inhibitory Control Technique (ICT ); or sham (placebo) tDCS with active or control ICT.

Patients will be evaluated with primary outcome measures (alcohol consumption patterns) and secondary outcome measures (working memory and changes in alcohol-related stimuli affective values).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with severe alcohol-use disorder (DSM-5 criteria), hospitalized for detoxification.
  • Severity of alcohol use disorder must be at least moderate (at least 4 DSM-5 criteria)
  • Aged between 18 and 65 years
  • Comorbidity with anxiety disorders and depressive disorders is allowed
  • Patients must be illegal drug free for 3 weeks at beginning of trial
  • Pharmacotherapy: patients should be benzodiazepines free at the moment of inclusion. They are allowed to continue other psychotropic medication (antidepressants, antipsychotics, mood stabilizers), providing they are following a stable regimen that will not be changed during the protocol time.
  • Patients must be reachable for follow-up

Exclusion criteria

  • Previous neurological conditions (epilepsy, traumatic brain injury, stroke)
  • Present delirium, confusion or severe cognitive disorder
  • Schizophrenia, chronic psychotic disorders, bipolar type 1 disorder.
  • Any severe, life-threatening disorders
  • High suicidal risk
  • Specific contraindications for tDCS: metallic plates in the head
  • Alcohol medication treatment initiated during the rehab: acamprosate, disulfiram, baclofen, nalmefen.

Treatment and study plan

Combined TDCS active and ICT active

Behavioral

Five 20-minute long sessions including TDCS (2 MicroAmperes during 20 minutes) and ICT, 5 consecutive days

Other names: Experimental

Combined TDCS sham and ICT active

Behavioral

Five 20-minute long sessions including TDCS sham (non active) and ICT, 5 consecutive days

Other names: Sham/active

Combined TDCS active and ICT inactive

Behavioral

Five 20-minute long sessions including TDCS sham and no-cue inhibition training, 5 consecutive days

Other names: Sham/inactive

Combined Sham TDCS and inactive ICT

Behavioral

Five 20-minute long sessions including TDCS and no-cue inhibition training, 5 consecutive days

Other names: Active/inactive

Primary outcomes

  1. Reduction of alcohol use in post-treatment at week 2

    Time frame: é weeks post-rehab

    Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)

  2. Reduction of alcohol use in post-treatment at week 4

    Time frame: 4 weeks post-rehab

    Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)

  3. Reduction of the relapse rate in post-treatment at week 2

    Time frame: 2 weeks post-rehab

    Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)

  4. Reduction of the relapse rate in post-treatment at week 4

    Time frame: 4 weeks post-rehab

    Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)

  5. Reduction of alcohol use in post-treatment at week 12

    Time frame: 12 weeks post-rehab

    Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)

  6. Reduction of the relapse rate in post-treatment at week 12

    Time frame: 12 weeks post-rehab

    Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)

  7. Reduction of alcohol use in post-treatment at week 24

    Time frame: 24 weeks post-rehab

    Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)

  8. Reduction of the relapse rate in post-treatment at week 24

    Time frame: 24 weeks post-rehab

    Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)

Secondary outcomes

  1. Cue reactivity (attractiveness) at day 22

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

    measures of attractiveness of used and novel alcohol-related pictures: Likert scale ranging from not (score of 0) at all to very much (score of 9)

  2. Cue reactivity at day 22

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

    measures of attractiveness of used and novel alcohol-related pictures: Likert scale ranging from not (score of 0) at all to very much (score of 9)

  3. Cue reactivity (valence) at day 22

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

    emotional content (valence) of pictures used in the response inhibition practice and of new pictures. Likert scale ranging from not (score of 0) at all to very much (score of 9)

  4. Cue reactivity (arousal) at day 22

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

    emotional content (arousal) of pictures used in the response inhibition practice and of new pictures. Likert scale ranging from not (score of 0) at all to very much (score of 9)

  5. Cue reactivity (alcohol verbal fluency) at day 12

    Time frame: at baseline (day 12 of hospitalization)

    Alcohol verbal fluency (from Goldstein et al., 2007; Drug and Alcohol Dependence, 89:97-101 and Hon et al., 2016, Psychopharmacology, 233: 851-861: Participants are instructed to name as many alcohol-related words as possible in 1 min. Responses were audio recorded and independently coded into three categories: neutral, positive and negative valence by two researchers.

  6. Cue reactivity (alcohol verbal fluency) at day 22

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

    Alcohol verbal fluency (from Goldstein et al., 2007; Drug and Alcohol Dependence, 89:97-101 and Hon et al., 2016, Psychopharmacology, 233: 851-861: Participants are instructed to name as many alcohol-related words as possible in 1 min. Responses were audio recorded and independently coded into three categories: neutral, positive and negative valence by two researchers.

  7. response inhibition at day 12

    Time frame: at baseline (day 10 of hospitalization)

    stop signal task (Logan, 1994): Stop Signal Reaction Time measure

  8. response inhibition at day 22

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

    stop signal task (Logan, 1994): Stop Signal Reaction Time measure

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Collaborators

  • University Ghent
  • Université Libre de Bruxelles

Registry information

Official study title

Treating Alcohol Dependence : Testing a Combined Treatment Model Using Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Training (ICT)

Acronym: ALCOSTIM

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2018
Registry last updated
Nov 4, 2020

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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