TRIS: Contingency Management App for Alcohol Use Disorder

Remote Treatment With Incentives for Sobriety (TRIS): A Randomized Controlled Trial of a Contingency Management App for Alcohol Use Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use Disorder (AUD)
• Intervention / Treatment: Behavioral: Remote Contingency Management (CM); Behavioral: Treatment as Usual (TAU)

Detailed Description

A total of 130 adults with Alcohol Use Disorder (AUD) from two public outpatient clinics in São Paulo, Brazil, will be randomized (1:1) to the experimental or control group. The experimental group will receive standard outpatient treatment plus 12 weeks of remote Contingency Management (CM) delivered through the TRIS mobile application. Participants will submit three daily breath alcohol concentration (BrAC) samples at 1:00 p.m., 5:00 p.m., and 9:00 p.m. using a BACtrack Bluetooth breathalyzer connected to the app. Financial incentives will be provided when all three daily samples are submitted on time and are alcohol-negative (BrAC = 0.00). Incentives begin at R$5.00 per day and increase by R$2.00 for each consecutive day of verified abstinence, up to a maximum of R$15.00 per day. Missed or alcohol-positive samples reset the incentive value to R$5.00 on the next eligible day. Incentives will be redeemed via PIX transfer. The control group will receive standard outpatient treatment and will also use the TRIS application and BACtrack breathalyzer to submit three daily BrAC samples but will not receive contingency management incentives. The primary outcome is the number of biochemically verified days of alcohol abstinence during the 12-week intervention. Secondary outcomes include days without heavy alcohol use, treatment adherence, usability and acceptability of the TRIS application, alcohol withdrawal severity, obsessive-compulsive drinking symptoms, alcohol craving, alcohol use severity, quality of life, psychiatric symptoms, disability, and healthcare service utilization. Assessments will be conducted at baseline, weekly during the 12-week intervention, and at follow-up visits scheduled at Weeks 16, 20, and 24.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vinicius Soares, PhD; Phone Number: +55 19 99586-4530; Email: viniciusnagy@gmail.com
• Study Contact Backup: Name: Aline Camargo Ramos, PhD; Phone Number: +55 11 95359-8039; Email: aline.camargoramos@usp.br

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05021-001
      • Recruiting
      • IPER Research Center
      • Contact: Vinicius Soares, PhD; Phone Number: +55 19 99586-4530; Email: viniciusnagy@gmail.com
      • Contact: Thais Rocha, MSc; Phone Number: ‪+55 11 99243-3412‬; Email: thais.mentor@gmail.com
      • Principal Investigator: Paulo Menezes, PhD
      • Principal Investigator: André Miguel, PhD
      • Sub-Investigator: Vinicius Soares, PhD
      • Sub-Investigator: Thais Rocha, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contingency Management (CM) + Treatment as Usual (TAU); 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); Remote contingency management delivered through the TRIS mobile application. Participants submit three daily breath alcohol concentration (BrAC) samples using a Bluetooth-enabled BACtrack breathalyzer. Monetary incentives ranging from R$5.00 to R$15.00 per day are provided contingent on verified alcohol abstinence.
Active Comparator: Treatment as Usual (TAU); 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); Standard outpatient treatment for Alcohol Use Disorder provided at the participating outpatient clinics. Participants also use the TRIS mobile application and a Bluetooth-enabled BACtrack breathalyzer for remote alcohol monitoring but do not receive contingency management incentives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days of Alcohol Abstinence	Number of days with verified abstinence based on three daily BrAC samples submitted via the BACtrack remote breathalyzer over the 12-week intervention period.	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days without Heavy Alcohol Consumption	Description: Number of days in which all three daily BrAC samples are below 0.06 during the 12-week intervention period.	Up to 12 weeks
App Usability	Usability and acceptability of the TRIS mobile application assessed at the end of the intervention using a study-specific questionnaire.	Week 12 (end of intervention)
Clinical Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar)	The Clinical Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar) is a 10-item clinician-administered scale assessing alcohol withdrawal severity. Scores range from 0 to 67, with higher scores indicating more severe alcohol withdrawal symptoms.	Baseline (Week 0), weekly during Weeks 1-12, and follow-up at Weeks 16, 20, and 24.
Obsessive-Compulsive Drinking Scale (OCDS)	The Obsessive-Compulsive Drinking Scale (OCDS) is a 14-item self-report measure assessing obsessive thoughts and compulsive behaviors related to alcohol use. Scores range from 0 to 56, with higher scores indicating greater alcohol craving and obsessive-compulsive drinking symptoms.	Baseline (Week 0), weekly during Weeks 1-12, and follow-up at Weeks 16, 20, and 24.
Treatment Adherence	Number of days the participant remains engaged in the 12-week intervention, based on attendance and study procedures.	Up to 12 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: University of Sao Paulo; Medical school of the University of São Paulo (FMUSP)
• Investigators: Principal Investigator: André Miguel, PhD, Washington State University

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: July 27, 2026
• First Posted (Actual): July 30, 2026

Study Record Updates

• Last Update Posted (Actual): July 30, 2026
• Last Update Submitted That Met QC Criteria: July 27, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Contingency Management; Alcohol Use Disorder; Sobriety
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism; Therapeutics
• Other Study ID Numbers: 78651424.2.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The study team has not yet made a final decision regarding the sharing of de-identified individual participant data (IPD). A data sharing plan will be established after study completion in accordance with institutional policies, participant consent, and applicable ethical and regulatory requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No