Smartphone Application for University Students With Binge Drinking Behavior

NCT ID: NCT06084832

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

628 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Alcohol use is a causal factor in more than 200 diseases and injury conditions (see ICD-10) and in France, alcohol is the first cause of hospitalization. Binge drinking (BD) has emerged as a major public health issue among student populations and is associated with negative consequences and social, cognitive and brain alterations. More than half of French university students have reported BD in the past month and are at increased risk of several alcohol-related consequences such as memory and sleep impairments, and reduced quality of life. BD is also a major risk factor in the development of alcohol addiction, with individual and environmental factors playing a role that is still poorly understood. Moreover, most students and young adults are reluctant to seek interventions when it is provided by health care professionals (only 4-5%) and have poor insight with regard to their alcohol use patterns / habits. Thus, there is an urgent need for developing effective prevention and intervention programs to reduce alcohol drinking in students. Recent studies have demonstrated that new types of technology-delivered interventions are promising tools for addressing unhealthy alcohol use. For example, an uncontrolled trial pilot study using a smartphone application-delivered intervention produced a reduction in both number of drinks per week and BD from baseline to 3-month follow-up. A recent review also showed significant outcomes of a mobile health intervention for self-control of unhealthy alcohol use. The investigators hypothesize that a timeline follow-back and personalized feedback based on the use of a mobile application can reduce excessive alcohol intake at 3-months. This study will provide scientific knowledge about BD in students, but also regarding a new type of intervention that could be effective for prevention in non-treatment seeking individuals and reducing the severity of health problems associated with excessive alcohol intake.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Drinking Binge Drinking

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Binge Drinking

Group Type EXPERIMENTAL

blood microsampling

Intervention Type BIOLOGICAL

blood microsampling for the measure of Phosphatidylethanol

Binge Drinking-control

Group Type ACTIVE_COMPARATOR

blood microsampling

Intervention Type BIOLOGICAL

blood microsampling for the measure of Phosphatidylethanol

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blood microsampling

blood microsampling for the measure of Phosphatidylethanol

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Students between 18 and 25 years old
* AUQ score greater than or equal to 24, and AUDIT score greater than or equal to 3 for its first 3 items. Drinking details with the DDQ when necessary.
* BD behavior: at least one occasion with 6 or more drinks in the last 3 months.
* Consent to be included in the study
* Affiliated to social security

Exclusion Criteria

* Not having a smartphone with an Apple or Android system.
* Previous use of the MyDéfi smartphone application
* Declaration of a psychiatric / neurologic condition
* Pregnant, parturient or breastfeeding woman
* Subject under guardianship, curators or restricted under public law
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

EPSM Marne, Reims

UNKNOWN

Sponsor Role collaborator

SCA-LAB UMR-CNRS 9193, Lille

UNKNOWN

Sponsor Role collaborator

Paul Valery University, Montpellier

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Amiens Picardie

Amiens, Picardie, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mickael Naasila, Pr

Role: CONTACT

03.22.82.76.72

Sandra Bodeau, Dr

Role: CONTACT

03.22.08.70.34

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sandra BODEAU, Dr

Role: primary

+33322087029

Mickael Naasila, Pr

Role: backup

03.22.82.76.72

References

Explore related publications, articles, or registry entries linked to this study.

Andre C, Sauton P, Dreinaza M, Diouf M, Bodeau S, Martinetti M, Trouillet R, de Groote C, Nandrino JL, Alexandre A, Benzerouk F, Gierski F, Perney P, Grellet L, Andre J, Naassila M. Effect of the MyDefi Smartphone Application on Binge Drinking Among University Students: Protocol of a Double-Blind Multicenter Prospective National Randomized Controlled Trial Using Phosphatidylethanol as a Biomarker-The SMARTBINGE Trial. Int J Methods Psychiatr Res. 2025 Jun;34(2):e70014. doi: 10.1002/mpr.70014.

Reference Type DERIVED
PMID: 40165584 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI2023_843_0069

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Smartphone Technology: Young Adult Drinking
NCT02963818 COMPLETED PHASE1/PHASE2
The UniVenture Program
NCT05383989 UNKNOWN NA
College Student Daily Life and Alcohol Use Study
NCT06365125 ACTIVE_NOT_RECRUITING NA