Clinical trial NCT04656925: Automated Reinforcement Management System (ARMS)
Official title: Automated Reinforcement Management System (ARMS): Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A-B-A, or a return to baseline design.
Primary purpose: TREATMENT

Brief summary: Alcohol abuse remains a significant cause of preventable morbidity and mortality in the US. Yet only 15% of those with alcohol use disorders receive treatment. Contingency Management (CM) is a cost-effective intervention for drug addiction where individuals are rewarded when they submit biological verification of drug abstinence. The researchers propose to develop an integrated CM system capable of incorporating mobile device input, that would allow them to deliver a CM intervention for problematic drinking to anyone who owns a smartphone. The mobile device input will incorporate ecological momentary assessments (EMA), geospatial mapping, and biomarker-based feedback from a portable measuring device.

Detailed description: The researchers propose to develop an integrated Contingency Management (CM) system capable of incorporating mobile device input, which would allow them to deliver a CM intervention for problematic drinking to anyone who owns a smartphone. The location of participants through their cell phone will be recorded. The researchers will be using this data to create a "heat-map" to find problem areas of drinking. The application works only on iPhone 7 or a newer version with an (iPhone Operating System) iOS 13.5. If the participant does not have an iPhone 7 or a newer version, the researcher can loan one to the participant if he/she knows how to use it, but it must be returned at the end of the study.

The primary aim is to combine mobile technology, geospatial mapping, and biomarker measurement, with individual goal setting and ecological momentary assessments (EMA) feedback to launch behavioral modification strategies and progress monitoring.

People can participate if they are 1) age 18-65 years; 2) have an Alcohol Use Disorders Identification Test (AUDIT) score of 8 or higher; 3) have the ability to read and speak English; 4) have the ability to provide written informed consent; 5) have a breath alcohol of 0.00 during informed consent, and 6) can operate a smartphone with an active service provider.

The researchers will utilize an A-B-A completely within-subject design with the intent of recruiting twenty total participants from the Community in Spokane.

During the first A phase, participants will receive reinforcement for simply submitting breath samples 3 times per day between 4 and 6 hours apart.

During the B phase, the delivery of reinforcers will be contingent upon the submission of an alcohol negative breath sample on an escalating schedule.

The A phase or return to the baseline phase will involve the delivery reinforcers for simply submitting a sample during the designated windows of time.

The researchers will also collect other EMA data on stress, anxiety, depression, and other brief measures daily through participants' smartphone. Each phase will last a total of 4 weeks (i.e., 2 weeks of the first A phase, 4 weeks of the B phase, and then 2 more weeks of the A-phase) each for a total of 8 weeks of participation. Participants will be asked to submit 3 breath samples per day through a Bluetooth enabled breathalyzer developed by BACTrack no less than 8 hours apart and no more than 12 hours apart. Test results for breath alcohol will be available instantly to the participant and uploaded to the CM response system almost immediately.

As part of this CM system, participants will have the capability to receive multi-modal message reminders when they enter a new window of needed biochemical sample submission and additional reminders when the window of sample submission is about to close. While participants will receive information messages to this effect during the A phase, participants will receive additional personalized multi-modal message reminders once the CM platform can detect that they have entered a cold or hot zone. For example, upon entering a hot zone radius during the B phase wherein they had a greater 50% likelihood of drinking in that zone during the A phase, they will receive a text message encouraging them to change surroundings in order to better promote abstinence. Also, if the participant is within a window of time where they are eligible to submit a sample and receive a dose of reinforcement, this is another action that the individual can take to help bolster their attempt to remain abstinent. All these data (i.e., biochemical results, location of sample submission, time of submission, and other bits of data) will be collected and be presented in summary form to the research team. This will help the team devise an action plan if the participant's drinking behavior is proving impervious to intervention or if the participant's goals are being met, this is something the researcher can encourage about.

Eligibility criteria: Inclusion Criteria:

1. Age 18-65 years.
2. An Alcohol Use Disorders Identification Test (AUDIT) score of 8 or higher.
3. Ability to read and speak English.
4. Ability to provide written informed consent.
5. Breath alcohol of 0.00 during informed consent.
6. Operate a smartphone with an active service provider.

Exclusion Criteria:

1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) alcohol use disorder, severe type.
2. Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal.
3. Diagnosis of a psychotic disorder.
4. Lifetime suicide attempt or suicidality in the past year.
5. Any other medical or psychiatric condition that would compromise safe participation.

Primary outcomes:
measure: Biochemically Measured Change in Alcohol Abstinence.
timeFrame: Daily during 8 weeks (2 weeks of first A phase, 4 weeks of B phase, and 2 second A phase)
Secondary outcomes:
measure: Feasibility Indicator of App Usage
timeFrame: 8 weeks (2 weeks of first A phase, 4 weeks of B phase, and 2 second A phase)
measure: Treatment Retention
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Washington State University
state: Washington
Study officials:
References: