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Automated Reinforcement Management System (ARMS)

Automated Reinforcement Management System (ARMS): Phase I Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04656925
Acronym
ARMS
Enrollment
12
Registered
2020-12-07
Start date
2021-03-29
Completion date
2021-12-08
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

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.

Interventions

BEHAVIORALContingency management

Reinforcement, or incentives, in exchange for evidence of not drinking alcohol.

Sponsors

Washington State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A-B-A, or a return to baseline design.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Biochemically Measured Change in Alcohol Abstinence.Daily during 8 weeks (2 weeks of first A phase, 4 weeks of B phase, and 2 second A phase)Change in biochemically measured alcohol abstinence assessed through breath samples submitted three times daily.

Secondary

MeasureTime frameDescription
Feasibility Indicator of App Usage8 weeks (2 weeks of first A phase, 4 weeks of B phase, and 2 second A phase)Percentage of actual BAC samples submitted by the total number of possible submissions.
Treatment Retention8 WeeksDuration in weeks of treatment retention

Countries

United States

Participant flow

Participants by arm

ArmCount
Contingency Management A-B-A
All participants will be assigned a single arm where we will utilize an A-B-A, or return to baseline design where all participants will experience the intervention in between two baseline observation periods. Contingency management: Reinforcement, or incentives, in exchange for evidence of not drinking alcohol.
12
Total12

Baseline characteristics

CharacteristicContingency Management A-B-A
Age, Continuous39.5 Years
STANDARD_DEVIATION 8.6
Baseline EtG Result
Negative
1 Participants
Baseline EtG Result
Positive
11 Participants
Employment
Employed
9 Participants
Employment
Unemployed
3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
12 Participants
Region of Enrollment
United States
12 participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 120 / 12
other
Total, other adverse events
2 / 122 / 120 / 12
serious
Total, serious adverse events
0 / 120 / 120 / 12

Outcome results

Primary

Biochemically Measured Change in Alcohol Abstinence.

Change in biochemically measured alcohol abstinence assessed through breath samples submitted three times daily.

Time frame: Daily during 8 weeks (2 weeks of first A phase, 4 weeks of B phase, and 2 second A phase)

Population: This is a within subject design (each participant goes through all three phases, the two A phases are control phases and B is the experimental phase). The overall number of units is total BAC submission for all phases. The numbers analyzed below differ based on total number of samples submitted by phase.

ArmMeasureGroupValue (NUMBER)
Contingency Management A-B-ABiochemically Measured Change in Alcohol Abstinence.First A Phase347 Number of negative BAC samples by phase.
Contingency Management A-B-ABiochemically Measured Change in Alcohol Abstinence.B Phase615 Number of negative BAC samples by phase.
Contingency Management A-B-ABiochemically Measured Change in Alcohol Abstinence.Second A Phase209 Number of negative BAC samples by phase.
Secondary

Feasibility Indicator of App Usage

Percentage of actual BAC samples submitted by the total number of possible submissions.

Time frame: 8 weeks (2 weeks of first A phase, 4 weeks of B phase, and 2 second A phase)

Population: This is a within subject design (each participant goes through all three phases, the two A phases are control phases and B is the experimental phase). The overall number of units is total BAC submission for all phases. The numbers analyzed below differ based on total number of samples submitted by phase.

ArmMeasureGroupValue (NUMBER)
Contingency Management A-B-AFeasibility Indicator of App UsageFirst A Phase411 BAC samples actually submitted by phase
Contingency Management A-B-AFeasibility Indicator of App UsageB Phase700 BAC samples actually submitted by phase
Contingency Management A-B-AFeasibility Indicator of App UsageSecond A Phase249 BAC samples actually submitted by phase
Secondary

Treatment Retention

Duration in weeks of treatment retention

Time frame: 8 Weeks

ArmMeasureValue (MEAN)Dispersion
Contingency Management A-B-ATreatment Retention7.5 WeeksStandard Deviation 1.1

Source: ClinicalTrials.gov · Data processed: May 15, 2026