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

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Combined TDCS active and ICT active
Combined TDCS sham and ICT active
Combined TDCS active and ICT inactive
Combined Sham TDCS and inactive ICT
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Alcohol, tDCS, inhibition, cognitive training, implicit cognition, relapse, craving

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU-Brugmann

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Combined TDCS active and ICT active

Combined TDCS sham and ICT active

Combined TDCS active and ICT inactive

Combined Sham TDCS and inactive ICT

Arm Description

Five consecutive days: Twenty minutes of TDCS on the right dorsolateral prefrontal cortex while performing an alcohol-cue inhibitory control training consisting to systematically paired go responses with non-alcohol pictures and no-go responses with alcohol-related pictures.

Five consecutive days: Twenty minutes of sham TDCS on the right dorsolateral prefrontal cortex, while performing a no-cue go/no-go training consisting to carry out a go/no-go paradigm with no alcohol-related content.

Five consecutive days: Twenty minutes of active TDCS in association with no-cue go/no-go training consisting to carry out a go/no-go paradigm with no alcohol-related content.

Five consecutive days: Twenty minutes of Inactive TDCS combined with an non alcohol-cue inhibitory control training consisting to carry out a go/no-go paradigm with no alcohol-related content.

Outcomes

Primary Outcome Measures

Reduction of alcohol use in post-treatment at week 2
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Reduction of alcohol use in post-treatment at week 4
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Reduction of the relapse rate in post-treatment at week 2
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Reduction of the relapse rate in post-treatment at week 4
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Reduction of alcohol use in post-treatment at week 12
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Reduction of the relapse rate in post-treatment at week 12
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Reduction of alcohol use in post-treatment at week 24
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Reduction of the relapse rate in post-treatment at week 24
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)

Secondary Outcome Measures

Cue reactivity (attractiveness) at day 22
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)
Cue reactivity at day 22
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)
Cue reactivity (valence) at day 22
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)
Cue reactivity (arousal) at day 22
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)
Cue reactivity (alcohol verbal fluency) at day 12
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.
Cue reactivity (alcohol verbal fluency) at day 22
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.
response inhibition at day 12
stop signal task (Logan, 1994): Stop Signal Reaction Time measure
response inhibition at day 22
stop signal task (Logan, 1994): Stop Signal Reaction Time measure

Full Information

First Posted
November 3, 2017
Last Updated
November 3, 2020
Sponsor
Brugmann University Hospital
Collaborators
University Ghent, Université Libre de Bruxelles
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1. Study Identification

Unique Protocol Identification Number
NCT03447054
Brief Title
Severe Alcohol-use Disorder: a tDCS and Response Inhibition Training Intervention
Acronym
ALCOSTIM
Official Title
Treating Alcohol Dependence : Testing a Combined Treatment Model Using Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Training (ICT)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
March 18, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital
Collaborators
University Ghent, Université Libre de Bruxelles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Alcohol, tDCS, inhibition, cognitive training, implicit cognition, relapse, craving

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 (active, sham tDCS) x 2 (active, inactive response inhibition training) factorial design
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined TDCS active and ICT active
Arm Type
Experimental
Arm Description
Five consecutive days: Twenty minutes of TDCS on the right dorsolateral prefrontal cortex while performing an alcohol-cue inhibitory control training consisting to systematically paired go responses with non-alcohol pictures and no-go responses with alcohol-related pictures.
Arm Title
Combined TDCS sham and ICT active
Arm Type
Active Comparator
Arm Description
Five consecutive days: Twenty minutes of sham TDCS on the right dorsolateral prefrontal cortex, while performing a no-cue go/no-go training consisting to carry out a go/no-go paradigm with no alcohol-related content.
Arm Title
Combined TDCS active and ICT inactive
Arm Type
Active Comparator
Arm Description
Five consecutive days: Twenty minutes of active TDCS in association with no-cue go/no-go training consisting to carry out a go/no-go paradigm with no alcohol-related content.
Arm Title
Combined Sham TDCS and inactive ICT
Arm Type
Sham Comparator
Arm Description
Five consecutive days: Twenty minutes of Inactive TDCS combined with an non alcohol-cue inhibitory control training consisting to carry out a go/no-go paradigm with no alcohol-related content.
Intervention Type
Behavioral
Intervention Name(s)
Combined TDCS active and ICT active
Other Intervention Name(s)
Experimental
Intervention Description
Five 20-minute long sessions including TDCS (2 MicroAmperes during 20 minutes) and ICT, 5 consecutive days
Intervention Type
Behavioral
Intervention Name(s)
Combined TDCS sham and ICT active
Other Intervention Name(s)
Sham/active
Intervention Description
Five 20-minute long sessions including TDCS sham (non active) and ICT, 5 consecutive days
Intervention Type
Behavioral
Intervention Name(s)
Combined TDCS active and ICT inactive
Other Intervention Name(s)
Sham/inactive
Intervention Description
Five 20-minute long sessions including TDCS sham and no-cue inhibition training, 5 consecutive days
Intervention Type
Behavioral
Intervention Name(s)
Combined Sham TDCS and inactive ICT
Other Intervention Name(s)
Active/inactive
Intervention Description
Five 20-minute long sessions including TDCS and no-cue inhibition training, 5 consecutive days
Primary Outcome Measure Information:
Title
Reduction of alcohol use in post-treatment at week 2
Description
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Time Frame
é weeks post-rehab
Title
Reduction of alcohol use in post-treatment at week 4
Description
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Time Frame
4 weeks post-rehab
Title
Reduction of the relapse rate in post-treatment at week 2
Description
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Time Frame
2 weeks post-rehab
Title
Reduction of the relapse rate in post-treatment at week 4
Description
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Time Frame
4 weeks post-rehab
Title
Reduction of alcohol use in post-treatment at week 12
Description
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Time Frame
12 weeks post-rehab
Title
Reduction of the relapse rate in post-treatment at week 12
Description
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Time Frame
12 weeks post-rehab
Title
Reduction of alcohol use in post-treatment at week 24
Description
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Time Frame
24 weeks post-rehab
Title
Reduction of the relapse rate in post-treatment at week 24
Description
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Time Frame
24 weeks post-rehab
Secondary Outcome Measure Information:
Title
Cue reactivity (attractiveness) at day 22
Description
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)
Time Frame
at post-intervention (day 22 of hospitalization)
Title
Cue reactivity at day 22
Description
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)
Time Frame
at post-intervention (day 22 of hospitalization)
Title
Cue reactivity (valence) at day 22
Description
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)
Time Frame
at post-intervention (day 22 of hospitalization)
Title
Cue reactivity (arousal) at day 22
Description
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)
Time Frame
at post-intervention (day 22 of hospitalization)
Title
Cue reactivity (alcohol verbal fluency) at day 12
Description
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.
Time Frame
at baseline (day 12 of hospitalization)
Title
Cue reactivity (alcohol verbal fluency) at day 22
Description
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.
Time Frame
at post-intervention (day 22 of hospitalization)
Title
response inhibition at day 12
Description
stop signal task (Logan, 1994): Stop Signal Reaction Time measure
Time Frame
at baseline (day 10 of hospitalization)
Title
response inhibition at day 22
Description
stop signal task (Logan, 1994): Stop Signal Reaction Time measure
Time Frame
at post-intervention (day 22 of hospitalization)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU-Brugmann
City
Brussels
ZIP/Postal Code
++32
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34687964
Citation
Dubuson M, Kornreich C, Vanderhasselt MA, Baeken C, Wyckmans F, Dousset C, Hanak C, Veeser J, Campanella S, Chatard A, Jaafari N, Noel X. Transcranial direct current stimulation combined with alcohol cue inhibitory control training reduces the risk of early alcohol relapse: A randomized placebo-controlled clinical trial. Brain Stimul. 2021 Nov-Dec;14(6):1531-1543. doi: 10.1016/j.brs.2021.10.386. Epub 2021 Oct 20.
Results Reference
derived

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

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