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NCT07735585
TRIS: Contingency Management App for Alcohol Use Disorder
Conditions: Alcohol Use Disorder (AUD)
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 130
Sponsor: University of Sao Paulo General Hospital
Location: IPER Research Center São Paulo São Paulo
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.
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.
Source: ClinicalTrials.gov (NCT07735585). StuddyBuddy aggregates publicly available trial information.