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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05565989
Other study ID # 22-0099
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 3, 2022
Est. completion date July 4, 2024

Study information

Verified date September 2023
Source University Hospital, Caen
Contact Jessica MANGE, PhD
Phone 0033662669038
Email jessica.mange@unicaen.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The emergence of new problematic alcohol consumption practices among young people requires new dynamics in prevention strategies. In this context, the ADUC project (Alcohol and Drugs at the University of Caen) aims to develop a better understanding of alcohol consumption, and in particular the practice of binge drinking (BD), in order to develop relevant and adapted prevention tools. The ALCOMEDIIT study (IRESP funding; Agreement 20II31-00 - ADUC part 3) is a randomized controlled trial that focuses on the specific determinant of impulsivity. The main objective of this experiment in social psychology is to validate a program for the prevention of BD practices based on motivational interviewing (MI) associated with intention implementation (II) and mindfulness meditation (MBM) in a student environment.


Description:

Context. The emergence of new problematic alcohol consumption practices among young people requires new dynamics in prevention strategies. In this context, the ADUC project (Alcohol and Drugs at the University of Caen) aims to develop a better understanding of alcohol consumption, and in particular the practice of binge drinking (BD), in order to develop relevant and adapted prevention tools. The first step, logistically supported by the University of Caen, consisted in identifying the levels of alcohol consumption of students, the prevalence of binge drinking, and their determinants. Based on more than 7000 participants interviewed, it essentially demonstrated 1) an alarming 22% prevalence of BD among students and 2) four main psychological determinants, namely impulsivity (i.e., the tendency of individuals to act prematurely without fully weighing the consequences of their action), subjective norm (i.e., perception of what is done and/or approved by peers), drinker identity (i.e., how the individual defines him/herself as a drinker), and motivations to drink (social, compliance, enhancement, or coping motivations). Objective. The ALCOMEDIIT study (IRESP funding; Agreement 20II31-00 - ADUC part 3) is a randomized controlled trial that focuses on the specific determinant of impulsivity. The main objective of this experiment in social psychology is to validate a program for the prevention of BD practices based on motivational interviewing (MI) associated with intention implementation (II) and mindfulness meditation (MBM) in a student environment. Materials and Methods. This study will include 120 healthy subjects who will be students at the University of Caen Normandy. They will be people who consume alcohol, having a BD score > 1 in the month preceding the inclusion but not presenting any specific disorder. The trial will be proposed to them by e-mail and the people who meet the inclusion criteria will join either a control group which will benefit from a MI, or an experimental group which will also benefit from a MI but which will be associated with an initiation to MBM with II (initial visit T0). In order to measure the effectiveness of the prevention device in terms of reducing the use of BD, a follow-up at 1 month (T1) as well as a follow-up at 6 months (T6; exploratory) will be proposed to all participants. The total duration of this research protocol is one year. Hypothesis tested. The aim of this work is to evaluate the interest of associating mindfulness meditation practices, practices implemented to optimize their use, with a motivational interview in a prevention program aiming at reducing alcohol use and the practice of BD in the student population.


Recruitment information / eligibility

Status Recruiting
Enrollment 170
Est. completion date July 4, 2024
Est. primary completion date February 4, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - aged between 18 and 30 years old, - of French mother language, - of both sexes, - binge drinking score > 1, - having signed an informed consent. Exclusion Criteria: - Pregnant or breastfeeding students, - students who declare a history of neurological, neurosurgical, psychiatric, endocrine or infectious diseases.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MBM and II
An initiation to MBM practice (including 4 exercices) and 2 intention implementation exercices are proposed to participants
MI
A motivational Interview will be conducted with participant.

Locations

Country Name City State
France University of Caen Normandy Caen Normandie

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary binge drinking score The BD score (Townshend & Duka, 2005) is calculated on the basis of 3 distinct elements (Q1: "number of average standard drinks per hour (containing about 10g of pure alcohol in France)"; Q2: "number of drunken episodes in the last month" and Q3; "percentage of drunken episodes among the occasions of drinking"). The score results from the following weighting: (4 x Q1) + Q2*6 + (0.2 x Q3). This score considers both the quantity and frequency of drinking, thus integrating the dimension of repeated alcohol withdrawal. 1 month
Secondary craving 1 item measuring craving 1 month
Secondary craving 1 item measuring craving 6 months
Secondary impulsivity UPPS Scores 1 month
Secondary impulsivity UPPS Scores 6 months
Secondary Readiness to Change Alcohol consumption This self-assessment based on the transtheoretical model of behaviour change (Prochaska & DiClemente, 1982, DiClemente & Prochaska, 1982) is recognized for its reliability and validity. The RTC-Alcohol has three different scales that correspond to an assessment of the three main stages of behaviour change: the pre-contemplation, contemplation and action stages. Based on the person's score on each of these scales, the experimenter determines which stage of behavior change the person is in. 1 month
Secondary Readiness to Change Alcohol consumption This self-assessment based on the transtheoretical model of behaviour change (Prochaska & DiClemente, 1982, DiClemente & Prochaska, 1982) is recognized for its reliability and validity. The RTC-Alcohol has three different scales that correspond to an assessment of the three main stages of behaviour change: the pre-contemplation, contemplation and action stages. Based on the person's score on each of these scales, the experimenter determines which stage of behavior change the person is in. 6 months
Secondary alcohol use number of alcoholic drinks 6 month
Secondary binge drinking score The BD score (Townshend & Duka, 2005) is calculated on the basis of 3 distinct elements (Q1: "number of average standard drinks per hour (containing about 10g of pure alcohol in France)"; Q2: "number of drunken episodes in the last 6 months" and Q3; "percentage of drunken episodes among the occasions of drinking"). The score results from the following weighting: (4 x Q1) + Q2 + (0.2 x Q3). This score considers both the quantity and frequency of drinking, thus integrating the dimension of repeated alcohol withdrawal. 6 month
Secondary Alcohol use Number of alcoholic drinks 1 month
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