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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Binge Drinking, Alcohol Drinking
- 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 group | Role | What they receive |
|---|---|---|
| control (MI) | Active comparator | Motivational Interview Receives: Behavioral: MI |
| experimental (MI/MBM/II) | Experimental | Motivational 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.
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)
craving
1 item measuring craving
Measured: 1 month
craving
1 item measuring craving
Measured: 6 months
impulsivity
UPPS Scores
Measured: 1 month
impulsivity
UPPS Scores
Measured: 6 months
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
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
alcohol use
number of alcoholic drinks
Measured: 6 month
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
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.
- First posted4 Oct 2022
- Study start3 Oct 2022
- Primary completion28 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge DrinkingStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica MANGE, PhD, Principal investigator, University of Caen Normandy
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Consumption, Intention Implementation and Mindfulness Meditation (ADUC-Volet 3 " Prevention ")
- ClinicalTrials.gov ID
- NCT05565989
- Acronym / sponsor ID
- ALCOMEDIIT / 22-0099
- Conditions
- Binge Drinking, Alcohol Drinking
- Keywords
- mindfulness, intention implementation, motivationnal interview
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| control (MI) | Active comparator | Behavioral: MIMotivational Interview |
| experimental (MI/MBM/II) | Experimental | Behavioral: MBM and II, Behavioral: MIMotivational Interview + mindfulness-bases meditation practice + intention implementation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged between 18 and 30 years old,
- of French mother language,
- of both sexes,
- binge drinking score > 1,
- having signed an informed consent.
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding students,
- students who declare a history of neurological, neurosurgical, psychiatric, endocrine or infectious diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBM and IIAn initiation to MBM practice (including 4 exercices) and 2 intention implementation exercices are proposed to participants | Behavioural | experimental (MI/MBM/II) |
| MIA motivational Interview will be conducted with participant. | Behavioural | control (MI), experimental (MI/MBM/II) |
Primary outcome
binge drinking score
Time frame: 1 month
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.
9 secondary outcomes
craving
Time frame: 1 month
craving
Time frame: 6 months
impulsivity
Time frame: 1 month
impulsivity
Time frame: 6 months
Readiness to Change Alcohol consumption
Time frame: 1 month
Readiness to Change Alcohol consumption
Time frame: 6 months
alcohol use
Time frame: 6 month
binge drinking score
Time frame: 6 month
Alcohol use
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Derived from this study: PubMed 38169391Mange 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.
- Individual participant dataSharing planned: No. Study protocol and statistical analysis plan will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica MANGE, PhD principal investigator
University of Caen Normandy
1 site in 1 country: see every site and its status.
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.