NCT05565989

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

October 3, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2024

Completed
Last Updated

March 25, 2025

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

September 30, 2022

Last Update Submit

March 24, 2025

Conditions

Binge DrinkingAlcohol Drinking

Keywords

mindfulnessintention implementationmotivationnal interview

Outcome Measures

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.

    1 month

Secondary Outcomes (9)

  • craving

    1 month

  • craving

    6 months

  • impulsivity

    1 month

  • impulsivity

    6 months

  • Readiness to Change Alcohol consumption

    1 month

  • +4 more secondary outcomes

Study Arms (2)

control (MI)

ACTIVE COMPARATOR

Motivational Interview

Behavioral: MI

experimental (MI/MBM/II)

EXPERIMENTAL

Motivational Interview + mindfulness-bases meditation practice + intention implementation

Behavioral: MBM and IIBehavioral: MI

Interventions

MBM and IIBEHAVIORAL

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

experimental (MI/MBM/II)
MIBEHAVIORAL

A motivational Interview will be conducted with participant.

control (MI)experimental (MI/MBM/II)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Caen Normandy

Caen, Normandy, 14032, France

Location

Related Publications (1)

  • 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.

    PMID: 38169391DERIVED

MeSH Terms

Conditions

Binge DrinkingAlcohol Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersDrinking BehaviorBehaviorMental Disorders

Study Officials

  • Jessica MANGE, PhD

    University of Caen Normandy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 1 control condition implying a Motivational Interview (MI) 1 experimental condition implying a Motivational Interview (MI) + Mindfulness-Based Meditation practices (MBM) + Intention Implementation (II)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 4, 2022

Study Start

October 3, 2022

Primary Completion

May 28, 2024

Study Completion

May 28, 2024

Last Updated

March 25, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Study protocol and statistical analysis plan will be shared.

Locations

FR(1)