NCT06084832

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
628

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress95%
Oct 2023Jul 2026

Study Start

First participant enrolled

October 1, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

2.5 years

First QC Date

October 10, 2023

Last Update Submit

May 21, 2025

Conditions

Keywords

AlcoholBinge DrinkingPhosphatidylethanolSmartphoneHealth

Outcome Measures

Primary Outcomes (1)

  • Change of the number of standard drinks per week

    30 months

Secondary Outcomes (10)

  • Change of the PEth concentration

    3 months

  • Change of the PEth concentration

    6 months

  • Change of the PEth concentration

    9 months

  • Change of the PEth concentration

    12 months

  • Change of the PEth concentration

    15 months

  • +5 more secondary outcomes

Study Arms (2)

Binge Drinking

EXPERIMENTAL
Biological: blood microsampling

Binge Drinking-control

ACTIVE COMPARATOR
Biological: blood microsampling

Interventions

blood microsampling for the measure of Phosphatidylethanol

Binge DrinkingBinge Drinking-control

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alcohol DrinkingBinge Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 16, 2023

Study Start

October 1, 2023

Primary Completion

April 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations