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

Alcohol Use Disorder Clinical Trial

— ALCOSTIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447054
• Other study ID #: Baudoin_2016_J1130650_206500
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: November 2020
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: September 1, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Combined TDCS active and ICT active
Five 20-minute long sessions including TDCS (2 MicroAmperes during 20 minutes) and ICT, 5 consecutive days
• Combined TDCS sham and ICT active
Five 20-minute long sessions including TDCS sham (non active) and ICT, 5 consecutive days
• Combined TDCS active and ICT inactive
Five 20-minute long sessions including TDCS sham and no-cue inhibition training, 5 consecutive days
• Combined Sham TDCS and inactive ICT
Five 20-minute long sessions including TDCS and no-cue inhibition training, 5 consecutive days

Locations

Country	Name	City	State
Belgium	CHU-Brugmann	Brussels

Sponsors (3)

Lead Sponsor	Collaborator
Brugmann University Hospital	Université Libre de Bruxelles, University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	é weeks post-rehab
Primary	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)	4 weeks post-rehab
Primary	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)	2 weeks post-rehab
Primary	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)	4 weeks post-rehab
Primary	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)	12 weeks post-rehab
Primary	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)	12 weeks post-rehab
Primary	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)	24 weeks post-rehab
Primary	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)	24 weeks post-rehab
Secondary	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)	at post-intervention (day 22 of hospitalization)
Secondary	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)	at post-intervention (day 22 of hospitalization)
Secondary	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)	at post-intervention (day 22 of hospitalization)
Secondary	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)	at post-intervention (day 22 of hospitalization)
Secondary	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.	at baseline (day 12 of hospitalization)
Secondary	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.	at post-intervention (day 22 of hospitalization)
Secondary	response inhibition at day 12	stop signal task (Logan, 1994): Stop Signal Reaction Time measure	at baseline (day 10 of hospitalization)
Secondary	response inhibition at day 22	stop signal task (Logan, 1994): Stop Signal Reaction Time measure	at post-intervention (day 22 of hospitalization)

External Links

•   PI researchgate profile