Training Inhibition in Alcohol Use Disorder (TRAIN)
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|ClinicalTrials.gov Identifier: NCT03530384|
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : April 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Other: Cognitive training Other: Control training||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Training Inhibition in Alcohol Use Disorder: an add-on Randomized Controlled Trial|
|Actual Study Start Date :||February 25, 2019|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||November 30, 2022|
Experimental: Cognitive training
Computerized cognitive training program targeting inhibitory control
Other: Cognitive training
Computerized cognitive training targeting inhibitory control of motor response used during 45 minutes sessions twice a week for 6 weeks
Sham Comparator: Control Training
A sensorial program with similar conditions, but targeting visual acuity, considered as neutral in the addiction field
Other: Control training
Fictitious computerized training used during 45 minutes sessions twice a week for 6 weeks
- 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.
- 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 ]Genotyping of catechol-O-methyltransferase (COMT)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530384
|Contact: Amandine LUQUIENS, Dr||01 45 59 30 email@example.com|
|Paul Brousse Hospital||Recruiting|
|Villejuif, France, 94800|
|Contact: Amandine LUQIENS, Dr 01 45 59 30 87 firstname.lastname@example.org|