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NCT07735585

Overview

NCT ID: NCT07735585
Lead Sponsor: University of Sao Paulo General HospitalOTHER
Official Title: Remote Treatment With Incentives for Sobriety (TRIS): A Randomized Controlled Trial of a Contingency Management App for Alcohol Use Disorder
Brief 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.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 30, 2026Actual
Start Date: Feb 19, 2026Actual
Primary Completion Date: Aug 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 130Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Vinicius Soares, PhDContact
viniciusnagy@gmail.com+55 19 99586-4530

Similar Studies

Participant Group/Arms

Contingency Management (CM) + Treatment as Usual (TAU)Experimental

Participants receive standard outpatient treatment plus 12 weeks of remote contingency management delivered through the TRIS mobile application. Participants submit three breath alcohol concentration (BrAC) samples daily using a Bluetooth-enabled breathalyzer and receive escalating monetary incentives contingent on alcohol-negative breath samples.

Behavioral: Remote Contingency Management (CM)

Treatment as Usual (TAU)Active Comparator

Participants receive standard outpatient treatment for Alcohol Use Disorder and use the TRIS mobile application to submit three daily breath alcohol concentration (BrAC) samples using a Bluetooth-enabled breathalyzer. No monetary incentives are provided for alcohol-negative breath samples.

Behavioral: Treatment as Usual (TAU)