Alcohol Use DisorderTRAINNCT03530384
Training Inhibition in Alcohol Use Disorder
A study testing Cognitive training in people with Alcohol Use Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
More and more studies aim to improve neurocognitive functioning in alcohol use disorder, but very few studies have focused on training-inhibitory-control efficacy on alcohol intake. Our program relies on a comprehensive model of addiction considering inhibition deficit as the hallmark of addiction. 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?
- Cognitive training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2019to 26 Apr 2023
- 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
- Aged 18 to 65;
- With a current alcohol use disorder, according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5), and with at least a high drinking risk level (men: alcohol consumption >60 g/day; women >40 g/day), in the last 4-week drinking period ;
- Who must be abstinent since 7 to 30 days at the inclusion visit, no matter their drinking goal for the following period ;
- Who should not have been administered benzodiazepines since at least 3 days at the inclusion visit (to avoid interference with alcohol intoxication or withdrawal medication on the neuropsychological assessments in one hand, and any recall bias on drinking ones in the other hand);
- Affiliated to social security;
- Who has given a written informed consent.
Who cannot join
- Will not be included patients:
- With current alcohol withdrawal symptoms (Cushman score > 3) at the inclusion visit;
- With dual addiction (excluding tobacco);
- With psychiatric comorbidity (psychotic disorders, current manic/hypomanic episode, current major depressive episode), as assessed with the Mini International Neuropsychiatric Interview (MINI), Alzheimer disease, Korsakoff syndrome, mental retardation, or any condition that may significantly alter the computerized-task completion, as assessed by the clinician's judgment;
- Unable or unwilling to comply with the protocol requirements and/or unwilling to sign an informed consent form.
- Deprived of liberty or under legal protection measure.
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Training Inhibition in Alcohol Use Disorder: an add-on Randomized Controlled Trial
More and more studies aim to improve neurocognitive functioning in alcohol use disorder, but very few studies have focused on training-inhibitory-control efficacy on alcohol intake. Our program relies on a comprehensive model of addiction considering inhibition deficit as the hallmark of addiction. Our program proposes inhibition training on a task which does not refer to alcohol, combined with a debriefing promoting transferability of the enhanced skill and psychoeducation. In this perspective of aiming to retrain deficits involved in addiction in itself and not only due to alcohol toxicity. We propose an add-on single-blinded randomized controlled trial, in alcohol use disorder, assessing the efficacy of a computerized cognitive training program targeting inhibition as compared to treatment as usual.
Read the detailed description
Our hypothesis is that a computerized program aiming to retrain deficits involved in addiction in itself and not only due to alcohol toxicity i.e.inhibition training on tasks which do not refer to alcohol, combined with a debriefing promoting transferability of the enhanced skills, in addition to treatment as usual, is more effective than a control condition in addition to treatment as usual.
The program is a computerized cognitive training targeting inhibitory control of motor response (Scientific Brain Training®). The tasks included in the program have been selected and modified to target inhibition processes. The tasks are "find your way", "Don't fall in the trap", "Under pressure", "gulf-stream", "catch the ladybird" and an additional task: "Color and word Stroop test".
The program must be dispensed twice a week with at least in the week one session on site, the other either on site or at home via an application to download, during 6 weeks.
The duration for one session is 45 minutes, including:
- 30 minutes performing the selected modules with increasing level of difficulty corresponding to their personal improvement. The patient will be able to choose within the selected modules the ones they want to perform during one session.
- 15 minutes of group (for onsite sessions) debriefing mediated by a neuropsychologist. The debriefing will follow a semi-structured framework including a focus on the emotion associated with the task completion and a focus on the transferability of the tasks in the patient real life.
Control condition: A sensorial program with similar conditions (45 minutes sessions twice a week), but targeting visual acuity, considered as neutral in the addiction field.
- Conditions
- Alcohol Use Disorder
- Being tested
- Cognitive training, Control training
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingOther
Computerized cognitive training targeting inhibitory control of motor response used during 45 minutes sessions twice a week for 6 weeks
Control trainingOther
Fictitious computerized training used during 45 minutes sessions twice a week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training | Experimental | Computerized cognitive training program targeting inhibitory control Receives: Other: Cognitive training |
| Control Training | Sham comparator | A sensorial program with similar conditions, but targeting visual acuity, considered as neutral in the addiction field Receives: Other: Control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reduction in number of heavy drinking days between the last drinking 4-week period and 6 weeks, assessed with the Time Line Follow Back (TLFB).
The number of heavy drinking days (HDD) is defined as a day with an alcohol consumption ≥60 g for men and ≥40 g for women.
Measured: 6 weeks
Secondary outcomes (13)
Change in total alcohol consumption (g/day) between T1 and - T2, -T3 assessed with the TLFB
Measured: 12 weeks
Change in number of heavy drinking days between T1 and -T3 assessed with the TLFB
Measured: 12 weeks
Change in Alcohol Quality of life scale between T1 and -T2, -T3
Measured: 12 weeks
Change in Clinical Global Impression scale (CGI) severity between T1 and -T2, -T3
Measured: 12 weeks
Change in Difficulties in Emotion Regulation Scale-Impulse (DERS-IMPULSE ) between T1 and -T2, -T3
Measured: 12 weeks
Change in Stop Signal Reaction Time (SSRT) between T1 and -T2, T3
Measured: 12 weeks
Change in Stop-signal delay (SSD) from the Stop Signal Task (SST) between T1 and -T2, T3
Measured: 12 weeks
Change in Wechsler Adult Intelligence Scale (WAIS) between T1 and -T2, -T3
Measured: 12 weeks
Change in Corsi test between T1 and -T2, -T3
Measured: 12 weeks
Change in Brixton test between T1 and -T2, -T3
Measured: 12 weeks
Change in Trail Making Test (TMT) between T1 and -T2, -T3
Measured: 12 weeks
Change in Verbal fluencies test between T1 and -T2, -T3
Measured: 12 weeks
Description of the influence of catechol-O-methyltransferase (COMT) variant on efficacy
Genotyping of catechol-O-methyltransferase (COMT)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start25 Feb 2019
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530384
- Sponsor's protocol ID
- P160930J
- Other IDs
- 2017-A03558-45
- Acronym
- TRAIN
- Status last verified
- Mar 2023
- First submitted
- 13 Apr 2018
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Inhibition in Alcohol Use Disorder: an add-on Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03530384
- Acronym / sponsor ID
- TRAIN / P160930J
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 21 May 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.
More and more studies aim to improve neurocognitive functioning in alcohol use disorder, but very few studies have focused on training-inhibitory-control efficacy on alcohol intake. Our program relies on a comprehensive model of addiction considering inhibition deficit as the hallmark of addiction. Our program proposes inhibition training on a task which does not refer to alcohol, combined with a debriefing promoting transferability of the enhanced skill and psychoeducation. In this perspective of aiming to retrain deficits involved in addiction in itself and not only due to alcohol toxicity. We propose an add-on single-blinded randomized controlled trial, in alcohol use disorder, assessing the efficacy of a computerized cognitive training program targeting inhibition as compared to treatment as usual.
Detailed description
Our hypothesis is that a computerized program aiming to retrain deficits involved in addiction in itself and not only due to alcohol toxicity i.e.inhibition training on tasks which do not refer to alcohol, combined with a debriefing promoting transferability of the enhanced skills, in addition to treatment as usual, is more effective than a control condition in addition to treatment as usual.
The program is a computerized cognitive training targeting inhibitory control of motor response (Scientific Brain Training®). The tasks included in the program have been selected and modified to target inhibition processes. The tasks are "find your way", "Don't fall in the trap", "Under pressure", "gulf-stream", "catch the ladybird" and an additional task: "Color and word Stroop test".
The program must be dispensed twice a week with at least in the week one session on site, the other either on site or at home via an application to download, during 6 weeks.
The duration for one session is 45 minutes, including:
- 30 minutes performing the selected modules with increasing level of difficulty corresponding to their personal improvement. The patient will be able to choose within the selected modules the ones they want to perform during one session.
- 15 minutes of group (for onsite sessions) debriefing mediated by a neuropsychologist. The debriefing will follow a semi-structured framework including a focus on the emotion associated with the task completion and a focus on the transferability of the tasks in the patient real life.
Control condition: A sensorial program with similar conditions (45 minutes sessions twice a week), but targeting visual acuity, considered as neutral in the addiction field.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive training | Experimental | Other: Cognitive trainingComputerized cognitive training program targeting inhibitory control |
| Control Training | Sham comparator | Other: Control trainingA sensorial program with similar conditions, but targeting visual acuity, considered as neutral in the addiction field |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 to 65;
- With a current alcohol use disorder, according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5), and with at least a high drinking risk level (men: alcohol consumption >60 g/day; women >40 g/day), in the last 4-week drinking period ;
- Who must be abstinent since 7 to 30 days at the inclusion visit, no matter their drinking goal for the following period ;
- Who should not have been administered benzodiazepines since at least 3 days at the inclusion visit (to avoid interference with alcohol intoxication or withdrawal medication on the neuropsychological assessments in one hand, and any recall bias on drinking ones in the other hand);
- Affiliated to social security;
Key exclusion criteria (7 listed)
- With current alcohol withdrawal symptoms (Cushman score > 3) at the inclusion visit;
- With dual addiction (excluding tobacco);
- With psychiatric comorbidity (psychotic disorders, current manic/hypomanic episode, current major depressive episode), as assessed with the Mini International Neuropsychiatric Interview (MINI), Alzheimer disease, Korsakoff syndrome, mental retardation, or any condition that may significantly alter the computerized-task completion, as assessed by the clinician's judgment;
- Unable or unwilling to comply with the protocol requirements and/or unwilling to sign an informed consent form.
- Deprived of liberty or under legal protection measure.
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 |
|---|---|---|
| Cognitive trainingComputerized cognitive training targeting inhibitory control of motor response used during 45 minutes sessions twice a week for 6 weeks | Other | Cognitive training |
| Control trainingFictitious computerized training used during 45 minutes sessions twice a week for 6 weeks | Other | Control Training |
Primary outcome
The reduction in number of heavy drinking days between the last drinking 4-week period and 6 weeks, assessed with the Time Line Follow Back (TLFB).
Time frame: 6 weeks
The number of heavy drinking days (HDD) is defined as a day with an alcohol consumption ≥60 g for men and ≥40 g for women.
13 secondary outcomes
Change in total alcohol consumption (g/day) between T1 and - T2, -T3 assessed with the TLFB
Time frame: 12 weeks
Change in number of heavy drinking days between T1 and -T3 assessed with the TLFB
Time frame: 12 weeks
Change in Alcohol Quality of life scale between T1 and -T2, -T3
Time frame: 12 weeks
Change in Clinical Global Impression scale (CGI) severity between T1 and -T2, -T3
Time frame: 12 weeks
Change in Difficulties in Emotion Regulation Scale-Impulse (DERS-IMPULSE ) between T1 and -T2, -T3
Time frame: 12 weeks
Change in Stop Signal Reaction Time (SSRT) between T1 and -T2, T3
Time frame: 12 weeks
Change in Stop-signal delay (SSD) from the Stop Signal Task (SST) between T1 and -T2, T3
Time frame: 12 weeks
Change in Wechsler Adult Intelligence Scale (WAIS) between T1 and -T2, -T3
Time frame: 12 weeks
Change in Corsi test between T1 and -T2, -T3
Time frame: 12 weeks
Change in Brixton test between T1 and -T2, -T3
Time frame: 12 weeks
Change in Trail Making Test (TMT) between T1 and -T2, -T3
Time frame: 12 weeks
Change in Verbal fluencies test between T1 and -T2, -T3
Time frame: 12 weeks
Description of the influence of catechol-O-methyltransferase (COMT) variant on efficacy
Time frame: one day
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 7 Nov 2023.
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
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 Cognitive training in people with Alcohol Use Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 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 7 Nov 2023. 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 France. 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?
The reduction in number of heavy drinking days between the last drinking 4-week period and 6 weeks, assessed with the Time Line Follow Back (TLFB). (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.