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TRIS: Contingency Management App for Alcohol Use Disorder

27. juli 2026 oppdatert av: University of Sao Paulo General Hospital

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

130

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Brasil
    • São Paulo
      • São Paulo, São Paulo, Brasil, 05021-001
        • Rekruttering
        • IPER Research Center
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Paulo Menezes, PhD
        • Hovedetterforsker:
          • André Miguel, PhD
        • Underetterforsker:
          • Vinicius Soares, PhD
        • Underetterforsker:
          • Thais Rocha, MSc

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Aktiv komparator: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Days of Alcohol Abstinence
Tidsramme: Up to 12 weeks
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Days without Heavy Alcohol Consumption
Tidsramme: Up to 12 weeks
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
Tidsramme: Week 12 (end of intervention)
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)
Tidsramme: Baseline (Week 0), weekly during Weeks 1-12, and follow-up at Weeks 16, 20, and 24.
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)
Tidsramme: Baseline (Week 0), weekly during Weeks 1-12, and follow-up at Weeks 16, 20, and 24.
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
Tidsramme: Up to 12 weeks
Number of days the participant remains engaged in the 12-week intervention, based on attendance and study procedures.
Up to 12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Sao Paulo General Hospital

Samarbeidspartnere

University of Sao Paulo
Medical school of the University of São Paulo (FMUSP)

Etterforskere

  • Hovedetterforsker: André Miguel, PhD, Washington State University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. februar 2026

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

15. desember 2025

Først innsendt som oppfylte QC-kriteriene

27. juli 2026

Først lagt ut (Faktiske)

30. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. juli 2026

Sist bekreftet

1. desember 2025

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 78651424.2.0000.0068

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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