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CompletedNCT05565989ALCOMEDIITUpdated Mar 25, 2025

Alcohol Consumption, Intention Implementation and Mindfulness Meditation (ADUC-Volet 3 " Prevention ")

An interventional study of MBM and II and MI in Binge Drinking and Alcohol Drinking, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by University Hospital, Caen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Binge Drinking
  • Alcohol Drinking

Keywords

  • mindfulness
  • intention implementation
  • motivationnal interview
03

In context

Binge Drinking

71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.

This study's enrollment of 128 is close to the median of 120 across 64 interventional studies indexed under Binge Drinking.

Browse Binge Drinking studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 512 studies on the registry; 82 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • aged between 18 and 30 years old,
  • of French mother language,
  • of both sexes,
  • binge drinking score > 1,
  • having signed an .

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding students,
  • students who declare a history of neurological, neurosurgical, psychiatric, endocrine or infectious diseases.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (actual)

Study arms

  • Active comparator
    control (MI)

    Motivational Interview

    Behavioral: MI

  • Experimental
    experimental (MI/MBM/II)

    Motivational Interview + mindfulness-bases meditation practice + intention implementation

    Behavioral: MBM and II · Behavioral: MI

Interventions

  • BehavioralMBM and II

    An initiation to MBM practice (including 4 exercices) and 2 intention implementation exercices are proposed to participants

  • BehavioralMI

    A motivational Interview will be conducted with participant.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month

Secondary outcomes

  1. craving

    1 item measuring craving

    Time frame: 1 month

  2. craving

    1 item measuring craving

    Time frame: 6 months

  3. impulsivity

    UPPS Scores

    Time frame: 1 month

  4. impulsivity

    UPPS Scores

    Time frame: 6 months

  5. 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.

    Time frame: 1 month

  6. 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.

    Time frame: 6 months

  7. alcohol use

    number of alcoholic drinks

    Time frame: 6 month

  8. 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.

    Time frame: 6 month

  9. Alcohol use

    Number of alcoholic drinks

    Time frame: 1 month

07

Study locations

1 site
  • University of Caen Normandy
    Caen, Normandie 14032, France
08

References and documents

Individual participant data

Plan to share: No — Study protocol and statistical analysis plan will be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05565989
Responsible party
Sponsor
First posted
Oct 4, 2022
Start date
Oct 3, 2022
Primary completion
May 28, 2024
Completion
May 28, 2024
Last update
Mar 25, 2025

Study contacts

Jessica MANGE, PhD
principal investigator · University of Caen Normandy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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