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TRIS: Contingency Management App for Alcohol Use Disorder

27 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

130

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Brasile
    • São Paulo
      • São Paulo, São Paulo, Brasile, 05021-001
        • Reclutamento
        • IPER Research Center
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Paulo Menezes, PhD
        • Investigatore principale:
          • André Miguel, PhD
        • Sub-investigatore:
          • Vinicius Soares, PhD
        • Sub-investigatore:
          • Thais Rocha, MSc

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Days of Alcohol Abstinence
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Days without Heavy Alcohol Consumption
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Sao Paulo General Hospital

Collaboratori

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

Investigatori

  • Investigatore principale: André Miguel, PhD, Washington State University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 febbraio 2026

Completamento primario (Stimato)

1 agosto 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

15 dicembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

27 luglio 2026

Primo Inserito (Effettivo)

30 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 luglio 2026

Ultimo verificato

1 dicembre 2025

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 78651424.2.0000.0068

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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