TRIS: a mobile app with breathalyzer to support sobriety in alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial tests whether adding TRIS, a Brazilian mobile app integrated with a Bluetooth breathalyzer, to standard outpatient care increases days of verified abstinence from alcohol. Participants are randomized to receive 12 weeks of remote contingency management via TRIS plus usual care or usual care with remote monitoring but no incentives. Daily BrAC samples are submitted through the app, and incentives are provided only when all three daily samples are alcohol-negative and on time. The study enrolls 130 adults with AUD from two public clinics in São Paulo and uses a 1:1 randomization. Primary outcome is the number of biochemically verified abstinent days during the 12-week period; secondary outcomes include patterns of use, adherence, usability, withdrawal, craving, and related symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Able to read and speak Portuguese.
* Provide signed informed consent.
* Age 18 to 70 years.
* Alcohol consumption within the past month.
* Current diagnosis of Alcohol Use Disorder (AUD).
* Seeking treatment for AUD at AME Vila Maria or Instituto Perdizes.
* Breath alcohol concentration (BrAC) of 0.00 at the time of consent.
* Own and be able to operate a smartphone with an active mobile service plan.
* Smartphone compatible with the Bluetooth frequency required for the BACtrack breathalyzer.

Exclusion Criteria:

* Crack cocaine use within the past 90 days.
* Any seizure episode within the past 12 months.
* Diagnosis of a psychotic disorder (DSM-5).
* Suicide attempt within the past two years.
* Any medical or psychiatric condition that may compromise safe participation, as determined by the study medical director.

Where it's running

• IPER Research Center
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: André Miguel, PhD — Washington State University
• Study coordinator: Vinicius Soares, PhD
• Email: viniciusnagy@gmail.com
• Phone: +55 19 99586-4530

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.