Alcohol Use Disorder (AUD)
Conditions
Keywords
Alcohol Use Disorder, Contingency Management, Sobriety
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.
Detailed description
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.
Interventions
BEHAVIORALRemote 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.
BEHAVIORALTreatment 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.
Sponsors
University of Sao Paulo General Hospital
University of Sao Paulo
Medical school of the University of São Paulo (FMUSP)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days of Alcohol Abstinence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days without Heavy Alcohol Consumption | 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. |
| App Usability | 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. |
| 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. | 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. |
| Obsessive-Compulsive Drinking Scale (OCDS) | 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. |
| Treatment Adherence | Up to 12 weeks | Number of days the participant remains engaged in the 12-week intervention, based on attendance and study procedures. |
Countries
Brazil
Contacts
CONTACTVinicius Soares, PhD
CONTACTAline Camargo Ramos, PhD
PRINCIPAL_INVESTIGATORAndré Miguel, PhD
Washington State University
Outcome results
None listed