NCT03530384

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2023

Completed
Last Updated

November 7, 2023

Status Verified

March 1, 2023

Enrollment Period

4.2 years

First QC Date

April 13, 2018

Last Update Submit

November 3, 2023

Conditions

Alcohol Use Disorder

Outcome Measures

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).

    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.

    6 weeks

Secondary Outcomes (13)

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

    12 weeks

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

    12 weeks

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

    12 weeks

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

    12 weeks

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

    12 weeks

  • +8 more secondary outcomes

Study Arms (2)

Cognitive training

EXPERIMENTAL

Computerized cognitive training program targeting inhibitory control

Other: Cognitive training

Control Training

SHAM COMPARATOR

A sensorial program with similar conditions, but targeting visual acuity, considered as neutral in the addiction field

Other: Control training

Interventions

Cognitive trainingOTHER

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

Cognitive training
Control trainingOTHER

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

Control Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 ;
  • Affiliated to social security;
  • Who has given a written informed consent.

You may not qualify if:

  • Will not be included patients:
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paul Brousse Hospital

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2018

First Posted

May 21, 2018

Study Start

February 25, 2019

Primary Completion

April 26, 2023

Study Completion

April 26, 2023

Last Updated

November 7, 2023

Record last verified: 2023-03

Locations

FR(1)