Alcohol DrinkingSmartBingeNCT06084832
Smartphone Application for University Students With Binge Drinking Behavior
A study testing blood microsampling in people with Alcohol Drinking and Binge Drinking, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Alcohol Drinking, Binge Drinking
- What is being tested?
- blood microsampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2023to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, Picardie, 80054
Sandra BODEAU, Dr, +33322087029, bodeau.sandra@chu-amiens.fr
Mickael Naasila, Pr, 03.22.82.76.72, mickael.naassila@u-picardie.fr
About this study
Official title: Smartphone Application for University Students With Binge Drinking Behavior: National Randomized Controlled Trial
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.
- Conditions
- Alcohol Drinking, Binge Drinking
- Being tested
- blood microsampling
- Keywords
- Alcohol, Binge Drinking, Phosphatidylethanol, Smartphone, Health
- Medical subject headings
- Alcohol Drinking, Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood microsamplingBiological
blood microsampling for the measure of Phosphatidylethanol
| Study group | Role | What they receive |
|---|---|---|
| Binge Drinking | Experimental | Not described Receives: Biological: blood microsampling |
| Binge Drinking-control | Active comparator | Not described Receives: Biological: blood microsampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the number of standard drinks per week
Measured: 30 months
Secondary outcomes (10)
Change of the PEth concentration
phosphatidylethanol (PEth)
Measured: 3 months
Change of the PEth concentration
phosphatidylethanol (PEth)
Measured: 6 months
Change of the PEth concentration
phosphatidylethanol (PEth)
Measured: 9 months
Change of the PEth concentration
phosphatidylethanol (PEth)
Measured: 12 months
Change of the PEth concentration
phosphatidylethanol (PEth)
Measured: 15 months
Change of the PEth concentration
phosphatidylethanol (PEth)
Measured: 18 months
Change of the PEth concentration
phosphatidylethanol (PEth)
Measured: 21 months
Change of the PEth concentration
phosphatidylethanol (PEth)
Measured: 24 months
Change of the PEth concentration
phosphatidylethanol (PEth)
Measured: 27 months
Change of the PEth concentration
phosphatidylethanol (PEth)
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start1 Oct 2023
- Primary completionApr 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 628 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- EPSM Marne, Reims, SCA-LAB UMR-CNRS 9193, Lille, Paul Valery University, Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084832
- Sponsor's protocol ID
- PI2023_843_0069
- Acronym
- SmartBinge
- Status last verified
- May 2025
- First submitted
- 10 Oct 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40165584
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Application for University Students With Binge Drinking Behavior: National Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06084832
- Acronym / sponsor ID
- SmartBinge / PI2023_843_0069
- Conditions
- Alcohol Drinking, Binge Drinking
- Keywords
- Alcohol, Binge Drinking, Phosphatidylethanol, Smartphone, Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 628 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- EPSM Marne, Reims, SCA-LAB UMR-CNRS 9193, Lille, Paul Valery University, Montpellier
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binge Drinking | Experimental | Biological: blood microsampling |
| Binge Drinking-control | Active comparator | Biological: blood microsampling |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood microsamplingblood microsampling for the measure of Phosphatidylethanol | Biological | Binge Drinking, Binge Drinking-control |
Primary outcome
Change of the number of standard drinks per week
Time frame: 30 months
10 secondary outcomes
Change of the PEth concentration
Time frame: 3 months
Change of the PEth concentration
Time frame: 6 months
Change of the PEth concentration
Time frame: 9 months
Change of the PEth concentration
Time frame: 12 months
Change of the PEth concentration
Time frame: 15 months
Change of the PEth concentration
Time frame: 18 months
Change of the PEth concentration
Time frame: 21 months
Change of the PEth concentration
Time frame: 24 months
Change of the PEth concentration
Time frame: 27 months
Change of the PEth concentration
Time frame: 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Derived from this study: PubMed 40165584Andre 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood microsampling in people with Alcohol Drinking and Binge Drinking, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mickael Naasila, Pr (03.22.82.76.72, mickael.naassila@u-picardie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the number of standard drinks per week (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06084832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.