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Automated Reinforcement Management System (ARMS) (ARMS)

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency management
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Contingency management A-B-A

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Self-reported frequency of Alcohol use
Self-reported alcohol use measured by the Timeline Follow Back instrument to assess the frequency of daily drinking.
Self-reported quantity of Alcohol use
Self-reported alcohol use measured by the Timeline Follow Back instrument to assess the quantity of daily drinking.

Full Information

First Posted
September 15, 2020
Last Updated
January 26, 2022
Sponsor
Washington State University
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1. Study Identification

Unique Protocol Identification Number
NCT04656925
Brief Title
Automated Reinforcement Management System (ARMS)
Acronym
ARMS
Official Title
Automated Reinforcement Management System (ARMS): Phase I Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
December 8, 2021 (Actual)
Study Completion Date
December 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A-B-A, or a return to baseline design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contingency management A-B-A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Contingency management
Intervention Description
Reinforcement, or incentives, in exchange for evidence of not drinking alcohol.
Primary Outcome Measure Information:
Title
Biochemically measured change in alcohol abstinence.
Description
Change in biochemically measured alcohol abstinence assessed through breath samples submitted three times daily.
Time Frame
Daily during 8 Weeks of study
Secondary Outcome Measure Information:
Title
Self-reported frequency of Alcohol use
Description
Self-reported alcohol use measured by the Timeline Follow Back instrument to assess the frequency of daily drinking.
Time Frame
8 weeks
Title
Self-reported quantity of Alcohol use
Description
Self-reported alcohol use measured by the Timeline Follow Back instrument to assess the quantity of daily drinking.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Washington State University
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

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Automated Reinforcement Management System (ARMS)

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