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

Primary Purpose

Cognitive Intervention to Modify Addiction Behaviour of Alcohol-dependent Patients

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluative Conditionning Task
Sponsored by
Centre Hospitalier Henri Laborit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Intervention to Modify Addiction Behaviour of Alcohol-dependent Patients focused on measuring evaluative conditionning, addiction, alcohol, patients

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centre Hospitalier Henri Laborit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Conditionning

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
July 15, 2020
Last Updated
April 21, 2022
Sponsor
Centre Hospitalier Henri Laborit
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1. Study Identification

Unique Protocol Identification Number
NCT05341934
Brief Title
Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients
Acronym
CEAlcool
Official Title
Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No Inclusion/ Study never begin
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Laborit

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Intervention to Modify Addiction Behaviour of Alcohol-dependent Patients
Keywords
evaluative conditionning, addiction, alcohol, patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conditionning
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Evaluative Conditionning Task
Other Intervention Name(s)
Implicit Association Task, Subliminal Attitude Misattribution Procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
The reduction of automatic or implicit associations of Alcohol with positive affect.
Description
It will be evaluated by calculating the difference between the scores of the IAT task before and after the Evaluative Conditioning.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
The reduction in the total amount of alcohol consumed
Description
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).
Time Frame
week 2
Title
The reduction in the total amount of alcohol consumed
Description
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).
Time Frame
month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JAAFARI NEMATOLLAH, PROFESSOR
Organizational Affiliation
Centre Hospitalier Henri Laborit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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