Alcohol Use DisorderALCOSTIMNCT03447054
Severe Alcohol-use Disorder: a tDCS and Response Inhibition Training Intervention
A study testing Combined TDCS active and ICT active and Combined TDCS active and ICT inactive in people with Alcohol Use Disorder, run by Brugmann University Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Combined TDCS active and ICT active and Combined TDCS active and ICT inactive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2018to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treating Alcohol Dependence : Testing a Combined Treatment Model Using Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Training (ICT)
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.
Read the 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).
- Conditions
- Alcohol Use Disorder
- Being tested
- Combined TDCS active and ICT active, Combined TDCS sham and ICT active, Combined TDCS active and ICT inactive, Combined Sham TDCS and inactive ICT
- Keywords
- Alcohol, tDCS, inhibition, cognitive training, implicit cognition, relapse, craving
- Medical subject headings
- Alcoholism, Inhibition, Psychological, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined TDCS active and ICT activeBehavioural
Also called Experimental
Five 20-minute long sessions including TDCS (2 MicroAmperes during 20 minutes) and ICT, 5 consecutive days
Combined TDCS sham and ICT activeBehavioural
Also called Sham/active
Five 20-minute long sessions including TDCS sham (non active) and ICT, 5 consecutive days
Combined TDCS active and ICT inactiveBehavioural
Also called Sham/inactive
Five 20-minute long sessions including TDCS sham and no-cue inhibition training, 5 consecutive days
Combined Sham TDCS and inactive ICTBehavioural
Also called Active/inactive
Five 20-minute long sessions including TDCS and no-cue inhibition training, 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Combined TDCS active and ICT active | Experimental | 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. Receives: Behavioral: Combined TDCS active and ICT active |
| Combined TDCS sham and ICT active | Active comparator | 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. Receives: Behavioral: Combined Sham TDCS and inactive ICT |
| Combined TDCS active and ICT inactive | Active comparator | 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. Receives: Behavioral: Combined TDCS active and ICT inactive |
| Combined Sham TDCS and inactive ICT | Sham comparator | 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. Receives: Behavioral: Combined TDCS sham and ICT active |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: é weeks post-rehab
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)
Measured: 4 weeks post-rehab
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)
Measured: 2 weeks post-rehab
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)
Measured: 4 weeks post-rehab
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)
Measured: 12 weeks post-rehab
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)
Measured: 12 weeks post-rehab
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)
Measured: 24 weeks post-rehab
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)
Measured: 24 weeks post-rehab
Secondary outcomes (8)
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)
Measured: at post-intervention (day 22 of hospitalization)
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)
Measured: at post-intervention (day 22 of hospitalization)
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)
Measured: at post-intervention (day 22 of hospitalization)
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)
Measured: at post-intervention (day 22 of hospitalization)
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.
Measured: at baseline (day 12 of hospitalization)
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.
Measured: at post-intervention (day 22 of hospitalization)
response inhibition at day 12
stop signal task (Logan, 1994): Stop Signal Reaction Time measure
Measured: at baseline (day 10 of hospitalization)
response inhibition at day 22
stop signal task (Logan, 1994): Stop Signal Reaction Time measure
Measured: at post-intervention (day 22 of hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Jan 2018
- Primary completion18 Mar 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 (active, sham tDCS) x 2 (active, inactive response inhibition training) factorial design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Université Libre de Bruxelles
- Responsible party
- Principal investigator, Xavier NOËL, Brugmann University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447054
- Sponsor's protocol ID
- Baudoin_2016_J1130650_206500
- Acronym
- ALCOSTIM
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2017
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34687964
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Alcohol Dependence : Testing a Combined Treatment Model Using Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Training (ICT)
- ClinicalTrials.gov ID
- NCT03447054
- Acronym / sponsor ID
- ALCOSTIM / Baudoin_2016_J1130650_206500
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol, tDCS, inhibition, cognitive training, implicit cognition, relapse, craving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Collaborators
- University Ghent, Université Libre de Bruxelles
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- 2 (active, sham tDCS) x 2 (active, inactive response inhibition training) factorial design
| Arm | Type | Receives |
|---|---|---|
| Combined TDCS active and ICT active | Experimental | Behavioral: Combined TDCS active and ICT activeFive 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. |
| Combined TDCS sham and ICT active | Active comparator | Behavioral: Combined Sham TDCS and inactive ICTFive 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. |
| Combined TDCS active and ICT inactive | Active comparator | Behavioral: Combined TDCS active and ICT inactiveFive 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. |
| Combined Sham TDCS and inactive ICT | Sham comparator | Behavioral: Combined TDCS sham and ICT activeFive 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined TDCS active and ICT activeAlso: ExperimentalFive 20-minute long sessions including TDCS (2 MicroAmperes during 20 minutes) and ICT, 5 consecutive days | Behavioural | Combined TDCS active and ICT active |
| Combined TDCS sham and ICT activeAlso: Sham/activeFive 20-minute long sessions including TDCS sham (non active) and ICT, 5 consecutive days | Behavioural | Combined Sham TDCS and inactive ICT |
| Combined TDCS active and ICT inactiveAlso: Sham/inactiveFive 20-minute long sessions including TDCS sham and no-cue inhibition training, 5 consecutive days | Behavioural | Combined TDCS active and ICT inactive |
| Combined Sham TDCS and inactive ICTAlso: Active/inactiveFive 20-minute long sessions including TDCS and no-cue inhibition training, 5 consecutive days | Behavioural | Combined TDCS sham and ICT active |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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)
8 secondary outcomes
Cue reactivity (attractiveness) at day 22
Time frame: at post-intervention (day 22 of hospitalization)
Cue reactivity at day 22
Time frame: at post-intervention (day 22 of hospitalization)
Cue reactivity (valence) at day 22
Time frame: at post-intervention (day 22 of hospitalization)
Cue reactivity (arousal) at day 22
Time frame: at post-intervention (day 22 of hospitalization)
Cue reactivity (alcohol verbal fluency) at day 12
Time frame: at baseline (day 12 of hospitalization)
Cue reactivity (alcohol verbal fluency) at day 22
Time frame: at post-intervention (day 22 of hospitalization)
response inhibition at day 12
Time frame: at baseline (day 10 of hospitalization)
response inhibition at day 22
Time frame: at post-intervention (day 22 of hospitalization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 34687964Dubuson 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.
- PI researchgate profileLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined TDCS active and ICT active and Combined TDCS active and ICT inactive in people with Alcohol Use Disorder, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of alcohol use in post-treatment at week 2 (time frame: é weeks post-rehab). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03447054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.