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Binge DrinkingALCOMEDIITNCT05565989

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

A study testing MBM and II and MI in people with Binge Drinking and Alcohol Drinking, run by University Hospital, Caen at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Binge Drinking, Alcohol Drinking
What is being tested?
MBM and II and MI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteFrance
Study dates
3 Oct 2022to 28 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • Pregnant or breastfeeding students,
  • students who declare a history of neurological, neurosurgical, psychiatric, endocrine or infectious diseases.

Trial locations and contacts

1 site in 1 country.

France1 site

  • University of Caen Normandy

    Caen, Normandy, 14032

Other trials in France

About this study

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.

Being tested
MBM and II, MI
Keywords
mindfulness, intention implementation, motivationnal interview
Medical subject headings
Binge Drinking, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MBM and IIBehavioural

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

  • MIBehavioural

    A motivational Interview will be conducted with participant.

Study groups in NCT05565989
Study groupRoleWhat they receive
control (MI)Active comparatorMotivational Interview
Receives: Behavioral: MI
experimental (MI/MBM/II)ExperimentalMotivational Interview + mindfulness-bases meditation practice + intention implementation
Receives: Behavioral: MBM and II; Behavioral: MI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 month

Secondary outcomes (9)

  1. craving

    1 item measuring craving

    Measured: 1 month

  2. craving

    1 item measuring craving

    Measured: 6 months

  3. impulsivity

    UPPS Scores

    Measured: 1 month

  4. impulsivity

    UPPS Scores

    Measured: 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.

    Measured: 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.

    Measured: 6 months

  7. alcohol use

    number of alcoholic drinks

    Measured: 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.

    Measured: 6 month

  9. Alcohol use

    Number of alcoholic drinks

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study start3 Oct 2022
  3. Primary completion28 May 2024
  4. Study completion28 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
1 control condition implying a Motivational Interview (MI) 1 experimental condition implying a Motivational Interview (MI) + Mindfulness-Based Meditation practices (MBM) + Intention Implementation (II)
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05565989
Sponsor's protocol ID
22-0099
Acronym
ALCOMEDIIT
Status last verified
Sep 2023
First submitted
30 Sep 2022
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Study protocol and statistical analysis plan will be shared.

Publications

  • Mange J, Mauny N, Montcharmont C, Legrand E, Lemercier-Dugarin M, Mortier A, Duvivier M, Leveneur J, Lacherez C, Cabe N, Le Berre AP. A prevention program for binge drinking among students based on mindfulness and implementation intention (ALCOMEDIIT): a randomized controlled trial. Trials. 2024 Jan 2;25(1):1. doi: 10.1186/s13063-023-07887-9.

    PubMed 38169391

Questions about this trial

What is this clinical trial studying?

A study testing MBM and II and MI in people with Binge Drinking and Alcohol Drinking, run by University Hospital, Caen at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

binge drinking score (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05565989, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.

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