CEAlcool: Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients

Sponsor
Centre Hospitalier Henri Laborit (Other)
Overall Status
Withdrawn
CT.gov ID
NCT05341934
Collaborator
(none)
0
1
2
23.5
0

Study Details

Study Description

Brief Summary

Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluative Conditionning Task
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients
Actual Study Start Date :
Jan 15, 2018
Actual Primary Completion Date :
Dec 30, 2019
Actual Study Completion Date :
Dec 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Conditionning

Other: Evaluative Conditionning Task
A word will appear in one of the four quadrants on the computer screen. They will have to answer the word as quickly as possible by pressing the space bar. They will also be told that an image will be displayed briefly (400 ms) in the same quadrant by pressing the answer key. This procedure will be repeated for 120 trials: 30 trials with alcohol-related Conditional Stimulus (CS), 30 trials with CS related to non-alcoholic beverages and 60 trials with the CS of filling. The CS referring to alcohol will be the words Beer, Wine …; The CS referring to soft drinks will be the words Coca-Cola, Fanta… and Filling CS referring to vegetables and fruits will be: Apple, Banana…In experimental conditions, alcohol-related CS will be followed by negative Unconditional Stimuli (US) (images from the International Affective Picture System (Lang, Bradley, & Cuthbert, 1997)), CS referring to soft drinks linked to positive images and CS referring to fruits and vegetables will be linked to neutral US.
Other Names:
  • Implicit Association Task
  • Subliminal Attitude Misattribution Procedure
  • Placebo Comparator: Placebo

    Other: Evaluative Conditionning Task
    A word will appear in one of the four quadrants on the computer screen. They will have to answer the word as quickly as possible by pressing the space bar. They will also be told that an image will be displayed briefly (400 ms) in the same quadrant by pressing the answer key. This procedure will be repeated for 120 trials: 30 trials with alcohol-related Conditional Stimulus (CS), 30 trials with CS related to non-alcoholic beverages and 60 trials with the CS of filling. The CS referring to alcohol will be the words Beer, Wine …; The CS referring to soft drinks will be the words Coca-Cola, Fanta… and Filling CS referring to vegetables and fruits will be: Apple, Banana…In experimental conditions, alcohol-related CS will be followed by negative Unconditional Stimuli (US) (images from the International Affective Picture System (Lang, Bradley, & Cuthbert, 1997)), CS referring to soft drinks linked to positive images and CS referring to fruits and vegetables will be linked to neutral US.
    Other Names:
  • Implicit Association Task
  • Subliminal Attitude Misattribution Procedure
  • Outcome Measures

    Primary Outcome Measures

    1. The reduction of automatic or implicit associations of Alcohol with positive affect. [baseline]

      It will be evaluated by calculating the difference between the scores of the IAT task before and after the Evaluative Conditioning.

    Secondary Outcome Measures

    1. The reduction in the total amount of alcohol consumed [week 2]

      The reduction in the total amount of alcohol consumed (TAC: Total Alcohol Consumption) as well as the number of Heavy Drinking Day (HDD) over the 12-week period following treatment, with respect to the baseline time. The baseline time is the week before randomization. Consumption of alcohol (total quantity and consumption habits) during this period will be considered as a baseline. The HDD corresponds to the days of consumption of more than 60 grams of pure alcohol (men) or 40 grams (women).

    2. The reduction in the total amount of alcohol consumed [month 3]

      The reduction in the total amount of alcohol consumed (TAC: Total Alcohol Consumption) as well as the number of Heavy Drinking Day (HDD) over the 12-week period following treatment, with respect to the baseline time. The baseline time is the week before randomization. Consumption of alcohol (total quantity and consumption habits) during this period will be considered as a baseline. The HDD corresponds to the days of consumption of more than 60 grams of pure alcohol (men) or 40 grams (women).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Participants in this study will be patients:

    • With an alcohol use disorder according to DSM 5

    • Follow-up at the Laborit Hospital Center

    • Aged between 18 and 70 years with informed consent after receiving written information

    • Engaged in a process to reduce alcohol consumption

    • With a score of MOCA> 20

    • Whose mother tongue is French

    • Patients benefiting from social security or benefiting from it through a third party in accordance with the french law on research involving the human person.

    Exclusion Criteria:
      • Patient with less than 6 Heavy Drinking Days in the month
    • Patient with Schizophrenia

    • Patient with bipolar disorder Type 1

    • Patient with Korsakoff syndrome or degenerative neurological disorder

    • Patient with hearing impairment, uncorrected visual impairment

    • Patient under curatorship or guardianship

    • Patient with addiction to another substance other than tobacco

    • Patient already enrolled in another interventional study

    • Pregnant or nursing woman

    • Patient with difficulties of expression or comprehension in French

    • Patients in emergency situations or unable to give their consent.

    Output Criteria:
    • Patient who has manifested verbally or in writing, the desire to leave the study in progress.

    • Patient who will be hospitalized during the study for a problem related to his addiction.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Henri Laborit Poitiers France 86021

    Sponsors and Collaborators

    • Centre Hospitalier Henri Laborit

    Investigators

    • Principal Investigator: JAAFARI NEMATOLLAH, PROFESSOR, Centre Hospitalier Henri Laborit

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Henri Laborit
    ClinicalTrials.gov Identifier:
    NCT05341934
    Other Study ID Numbers:
    • 2017-A02120-53
    First Posted:
    Apr 22, 2022
    Last Update Posted:
    Apr 22, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Henri Laborit
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 22, 2022