TRIS: Contingency Management App for Alcohol Use Disorder

NCT07735585 | Recruiting DMC

• 1 other identifier: 78651424.2.0000.0068
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder (AUD)

Keywords

Alcohol Use Disorder; Contingency Management; Sobriety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Days without Heavy Alcohol Consumption

  Up to 12 weeks

• App Usability

  Week 12 (end of intervention)

• Clinical Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar)

  Baseline (Week 0), weekly during Weeks 1-12, and follow-up at Weeks 16, 20, and 24.

• Obsessive-Compulsive Drinking Scale (OCDS)

  Baseline (Week 0), weekly during Weeks 1-12, and follow-up at Weeks 16, 20, and 24.

• Treatment Adherence

  Up to 12 weeks

Study Arms (2)

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)

Interventions

Remote Contingency Management (CM) BEHAVIORAL

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.

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

Treatment as Usual (TAU) BEHAVIORAL

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.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical school of the University of São Paulo (FMUSP): collaborator
• University of Sao Paulo General Hospital: lead
• University of Sao Paulo: collaborator

Study Sites (1)

IPER Research Center

São Paulo, São Paulo, 05021-001, Brazil

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• André Miguel, PhD

  Washington State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinicius Soares, PhD

CONTACT

+55 19 99586-4530; viniciusnagy@gmail.com

Aline Camargo Ramos, PhD

CONTACT

+55 11 95359-8039; aline.camargoramos@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized in a 1:1 ratio to receive either standard outpatient treatment plus remote Contingency Management (CM) delivered through the TRIS mobile application or standard outpatient treatment with remote alcohol monitoring without contingency management incentives.

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: July 30, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2025-12

Locations

BR (1)