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

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

Study Overview

• Status: Withdrawn
• Conditions: Cognitive Intervention to Modify Addiction Behaviour of Alcohol-dependent Patients
• Intervention / Treatment: Other: Evaluative Conditionning Task

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86021
    • Centre Hospitalier Henri Laborit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The reduction of automatic or implicit associations of Alcohol with positive affect.	It will be evaluated by calculating the difference between the scores of the IAT task before and after the Evaluative Conditioning.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The reduction in the total amount of alcohol consumed	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).	week 2
The reduction in the total amount of alcohol consumed	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).	month 3

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: evaluative conditionning, addiction, alcohol, patients
• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior, Addictive
• Other Study ID Numbers: 2017-A02120-53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No