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.
