AzTrials
AzTrials

Alcohol Use DisorderARMSNCT04656925

Automated Reinforcement Management System (ARMS)

A study testing Contingency management in people with Alcohol Use Disorder, run by Washington State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Contingency management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
29 Mar 2021to 8 Dec 2021
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) alcohol use disorder, severe type.
  • 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.
  • Diagnosis of a psychotic disorder.
  • Lifetime suicide attempt or suicidality in the past year.
  • Any other medical or psychiatric condition that would compromise safe participation.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Washington State University

    Spokane, Washington, 99202

Other trials in United States

About this study

Official title: Automated Reinforcement Management System (ARMS): Phase I Study

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.

Read the 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.

Being tested
Contingency management
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contingency managementBehavioural

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

Study groups in NCT04656925
Study groupRoleWhat they receive
Contingency management A-B-AExperimentalAll 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.
Receives: Behavioral: Contingency management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemically Measured Change in Alcohol Abstinence.

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

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

Secondary outcomes (2)
  1. Feasibility Indicator of App Usage

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

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

  2. Treatment Retention

    Duration in weeks of treatment retention

    Measured: 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2020
  2. Study start29 Mar 2021
  3. Primary completion8 Dec 2021
  4. Study completion8 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A-B-A, or a return to baseline design.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04656925
Sponsor's protocol ID
IRB 18376
Acronym
ARMS
Status last verified
May 2026
First submitted
15 Sep 2020
Last updated
14 May 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in