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NCT Number: NCT06084832

Smartphone Application for University Students With Binge Drinking Behavior

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.

Recruiting

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

Farid BENZEROUK, DR

PRINCIPAL_INVESTIGATOR

Jean-Louis NANDRINO, Dr

PRINCIPAL_INVESTIGATOR

Mickael Naasila, Pr

CONTACT

[email protected]

03.22.82.76.72

Pierre SAUTON

SUB_INVESTIGATOR

Raphaël TROUILLET, Dr

PRINCIPAL_INVESTIGATOR

Sandra BODEAU, Dr

CONTACT

[email protected]

+33322087029

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood microsampling

Biological

blood microsampling for the measure of Phosphatidylethanol

Primary outcomes

  1. Change of the number of standard drinks per week

    Time frame: 30 months

Secondary outcomes

  1. Change of the PEth concentration

    Time frame: 3 months

    phosphatidylethanol (PEth)

  2. Change of the PEth concentration

    Time frame: 6 months

    phosphatidylethanol (PEth)

  3. Change of the PEth concentration

    Time frame: 9 months

    phosphatidylethanol (PEth)

  4. Change of the PEth concentration

    Time frame: 12 months

    phosphatidylethanol (PEth)

  5. Change of the PEth concentration

    Time frame: 15 months

    phosphatidylethanol (PEth)

  6. Change of the PEth concentration

    Time frame: 18 months

    phosphatidylethanol (PEth)

  7. Change of the PEth concentration

    Time frame: 21 months

    phosphatidylethanol (PEth)

  8. Change of the PEth concentration

    Time frame: 24 months

    phosphatidylethanol (PEth)

  9. Change of the PEth concentration

    Time frame: 27 months

    phosphatidylethanol (PEth)

  10. Change of the PEth concentration

    Time frame: 30 months

    phosphatidylethanol (PEth)

Study contacts

Contact information is provided by the study sponsor or research team.

Mickael Naasila, Pr

CONTACT

[email protected]

03.22.82.76.72

Sandra Bodeau, Dr

CONTACT

[email protected]

03.22.08.70.34

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • EPSM Marne, Reims
  • Paul Valery University, Montpellier
  • SCA-LAB UMR-CNRS 9193, Lille

Registry information

Official study title

Smartphone Application for University Students With Binge Drinking Behavior: National Randomized Controlled Trial

Acronym: SmartBinge

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2023
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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