TRIS: Contingency Management App for Alcohol Use Disorder
ConditionAlcohol Use Disorder (AUD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Sao Paulo General Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Able to read and speak Portuguese.
Provide signed informed consent.
Age 18 to 70 years.
Alcohol consumption within the past month.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Remote Contingency Management (CM)
BehavioralRemote 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.
Treatment as Usual (TAU)
BehavioralStandard 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 groups
130 Participants
are divided into 2 treatment groupsGroup A: Contingency Management (CM) + Treatment as Usual (TAU)Experimental treatment 1 intervention
Group B: Treatment as Usual (TAU)Active comparator 1 intervention
Trial outcomes
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.
Time frame
Up to 12 weeksSecondary outcomes
1
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.
Time frame
Up to 12 weeks2
App Usability
Usability and acceptability of the TRIS mobile application assessed at the end of the intervention using a study-specific questionnaire.
Time frame
Week 12 (end of intervention)3
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.
Time frame
Baseline (Week 0), weekly during Weeks 1-12, and follow-up at Weeks 16, 20, and 24.4
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.
Time frame
Baseline (Week 0), weekly during Weeks 1-12, and follow-up at Weeks 16, 20, and 24.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Sao Paulo General Hospital
Lead sponsor
University of Sao Paulo
Collaborator
Medical school of the University of São Paulo (FMUSP)
Collaborator
Source ClinicalTrials.gov