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Completed

NCT Number: NCT03530384

Training Inhibition in Alcohol Use Disorder

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paul Brousse Hospital

Villejuif, 94800, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Training

Other

Computerized cognitive training targeting inhibitory control of motor response used during 45 minutes sessions twice a week for 6 weeks

Control training

Other

Fictitious computerized training used during 45 minutes sessions twice a week for 6 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in total alcohol consumption (g/day) between T1 and - T2, -T3 assessed with the TLFB

    Time frame: 12 weeks

  2. Change in number of heavy drinking days between T1 and -T3 assessed with the TLFB

    Time frame: 12 weeks

  3. Change in Alcohol Quality of life scale between T1 and -T2, -T3

    Time frame: 12 weeks

  4. Change in Clinical Global Impression scale (CGI) severity between T1 and -T2, -T3

    Time frame: 12 weeks

  5. Change in Difficulties in Emotion Regulation Scale-Impulse (DERS-IMPULSE ) between T1 and -T2, -T3

    Time frame: 12 weeks

  6. Change in Stop Signal Reaction Time (SSRT) between T1 and -T2, T3

    Time frame: 12 weeks

  7. Change in Stop-signal delay (SSD) from the Stop Signal Task (SST) between T1 and -T2, T3

    Time frame: 12 weeks

  8. Change in Wechsler Adult Intelligence Scale (WAIS) between T1 and -T2, -T3

    Time frame: 12 weeks

  9. Change in Corsi test between T1 and -T2, -T3

    Time frame: 12 weeks

  10. Change in Brixton test between T1 and -T2, -T3

    Time frame: 12 weeks

  11. Change in Trail Making Test (TMT) between T1 and -T2, -T3

    Time frame: 12 weeks

  12. Change in Verbal fluencies test between T1 and -T2, -T3

    Time frame: 12 weeks

  13. Description of the influence of catechol-O-methyltransferase (COMT) variant on efficacy

    Time frame: one day

    Genotyping of catechol-O-methyltransferase (COMT)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Training Inhibition in Alcohol Use Disorder: an add-on Randomized Controlled Trial

Acronym: TRAIN

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 21, 2018
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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