Training Inhibition in Alcohol Use Disorder (TRAIN)
Primary Purpose
Alcohol Use Disorder
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive training
Control training
Sponsored by
About this trial
This is an interventional other trial for Alcohol Use Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
Sites / Locations
- Paul Brousse Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Cognitive training
Control Training
Arm Description
Computerized cognitive training program targeting inhibitory control
A sensorial program with similar conditions, but targeting visual acuity, considered as neutral in the addiction field
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in total alcohol consumption (g/day) between T1 and - T2, -T3 assessed with the TLFB
Change in number of heavy drinking days between T1 and -T3 assessed with the TLFB
Change in Alcohol Quality of life scale between T1 and -T2, -T3
Change in Clinical Global Impression scale (CGI) severity between T1 and -T2, -T3
Change in Difficulties in Emotion Regulation Scale-Impulse (DERS-IMPULSE ) between T1 and -T2, -T3
Change in Stop Signal Reaction Time (SSRT) between T1 and -T2, T3
Change in Stop-signal delay (SSD) from the Stop Signal Task (SST) between T1 and -T2, T3
Change in Wechsler Adult Intelligence Scale (WAIS) between T1 and -T2, -T3
Change in Corsi test between T1 and -T2, -T3
Change in Brixton test between T1 and -T2, -T3
Change in Trail Making Test (TMT) between T1 and -T2, -T3
Change in Verbal fluencies test between T1 and -T2, -T3
Description of the influence of catechol-O-methyltransferase (COMT) variant on efficacy
Genotyping of catechol-O-methyltransferase (COMT)
Full Information
NCT ID
NCT03530384
First Posted
April 13, 2018
Last Updated
March 27, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03530384
Brief Title
Training Inhibition in Alcohol Use Disorder
Acronym
TRAIN
Official Title
Training Inhibition in Alcohol Use Disorder: an add-on Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
227 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive training
Arm Type
Experimental
Arm Description
Computerized cognitive training program targeting inhibitory control
Arm Title
Control Training
Arm Type
Sham Comparator
Arm Description
A sensorial program with similar conditions, but targeting visual acuity, considered as neutral in the addiction field
Intervention Type
Other
Intervention Name(s)
Cognitive training
Intervention Description
Computerized cognitive training targeting inhibitory control of motor response used during 45 minutes sessions twice a week for 6 weeks
Intervention Type
Other
Intervention Name(s)
Control training
Intervention Description
Fictitious computerized training used during 45 minutes sessions twice a week for 6 weeks
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in total alcohol consumption (g/day) between T1 and - T2, -T3 assessed with the TLFB
Time Frame
12 weeks
Title
Change in number of heavy drinking days between T1 and -T3 assessed with the TLFB
Time Frame
12 weeks
Title
Change in Alcohol Quality of life scale between T1 and -T2, -T3
Time Frame
12 weeks
Title
Change in Clinical Global Impression scale (CGI) severity between T1 and -T2, -T3
Time Frame
12 weeks
Title
Change in Difficulties in Emotion Regulation Scale-Impulse (DERS-IMPULSE ) between T1 and -T2, -T3
Time Frame
12 weeks
Title
Change in Stop Signal Reaction Time (SSRT) between T1 and -T2, T3
Time Frame
12 weeks
Title
Change in Stop-signal delay (SSD) from the Stop Signal Task (SST) between T1 and -T2, T3
Time Frame
12 weeks
Title
Change in Wechsler Adult Intelligence Scale (WAIS) between T1 and -T2, -T3
Time Frame
12 weeks
Title
Change in Corsi test between T1 and -T2, -T3
Time Frame
12 weeks
Title
Change in Brixton test between T1 and -T2, -T3
Time Frame
12 weeks
Title
Change in Trail Making Test (TMT) between T1 and -T2, -T3
Time Frame
12 weeks
Title
Change in Verbal fluencies test between T1 and -T2, -T3
Time Frame
12 weeks
Title
Description of the influence of catechol-O-methyltransferase (COMT) variant on efficacy
Description
Genotyping of catechol-O-methyltransferase (COMT)
Time Frame
one day
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:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Paul Brousse Hospital
City
Villejuif
ZIP/Postal Code
94800
Country
France
12. IPD Sharing Statement
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Training Inhibition in Alcohol Use Disorder
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