TRIS: Contingency Management App for Alcohol Use Disorder (NCT07735585) | Clinical Trial Compass
RecruitingNot Applicable
TRIS: Contingency Management App for Alcohol Use Disorder
Brazil130 participantsStarted 2026-02-19
Plain-language summary
Alcohol Use Disorder (AUD) is a major public health concern associated with substantial morbidity, mortality, and impaired social and occupational functioning. Contingency Management (CM) is an evidence-based behavioral intervention that provides incentives contingent on abstinence and has demonstrated effectiveness in the treatment of substance use disorders. This study will evaluate the efficacy of Tratamento Remoto com Incentivos à Sobriedade (TRIS), a Brazilian mobile health application that integrates a smartphone app with a Bluetooth-enabled breathalyzer (BACtrack) to deliver remote CM for AUD. Participants will be randomized to receive either standard outpatient treatment plus TRIS-based CM or standard outpatient treatment with remote alcohol monitoring only. The primary objective is to determine whether TRIS-based CM increases biochemically verified alcohol abstinence compared with standard outpatient treatment alone.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.