Smartphone Application for University Students With Binge Drinking Behavior

Alcohol Drinking Clinical Trial

— SmartBinge  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084832
• Other study ID #: PI2023_843_0069
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: July 2026

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Mickael Naasila, Pr
• Phone: 03.22.82.76.72
• Email: mickael.naassila[@]u-picardie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 628
• Est. completion date: July 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Binge Drinking
• Drinking Behavior

Intervention

Biological:
• blood microsampling
blood microsampling for the measure of Phosphatidylethanol

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (4)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	EPSM Marne, Reims, Paul Valery University, Montpellier, SCA-LAB UMR-CNRS 9193, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the number of standard drinks per week		30 months
Secondary	Change of the PEth concentration	phosphatidylethanol (PEth)	3 months
Secondary	Change of the PEth concentration	phosphatidylethanol (PEth)	6 months
Secondary	Change of the PEth concentration	phosphatidylethanol (PEth)	9 months
Secondary	Change of the PEth concentration	phosphatidylethanol (PEth)	12 months
Secondary	Change of the PEth concentration	phosphatidylethanol (PEth)	15 months
Secondary	Change of the PEth concentration	phosphatidylethanol (PEth)	18 months
Secondary	Change of the PEth concentration	phosphatidylethanol (PEth)	21 months
Secondary	Change of the PEth concentration	phosphatidylethanol (PEth)	24 months
Secondary	Change of the PEth concentration	phosphatidylethanol (PEth)	27 months
Secondary	Change of the PEth concentration	phosphatidylethanol (PEth)	30 months