Automated Reinforcement Management Systems, Phase II (ARMS II)

August 9, 2024 updated by: Sterling McPherson, Washington State University
The Automated Reinforcement Management Systems Phase II (ARMS II) study is a phase II trial is a randomized controlled, non-medicated assisted trial to determine the effectiveness of Contingency Management (CM) treatment for reducing alcohol drinking among adults who want to quit or reduce their alcohol consumption.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Automated Reinforcement Management Systems Phase II (ARMS II) study is a phase II randomized controlled, non-medication assisted trial to determine the effectiveness of Contingency Management (CM) delivered remotely as a treatment for reducing alcohol consumption among drinking adults who want to reduce their consumption. The study will utilize an application developed by Managed Health Connections, Appropos Health, that connects to a Bluetooth breathalyzer to collect sample results and provide rewards to participants. Qualifying participants will be randomized into one of two groups, a Contingent or Non-Contingent group, and earn rewards based on the group they are randomized to. The contingent group will receive rewards on an escalating scale for submitting consecutive negative samples (0.00% BAC) at three time points per day: 11am, 4pm, and 9pm. The non-contingent group will earn rewards for submitting samples on time, independent of the test results. All rewards will be given in the form of electronic vouchers, which can be exchanged for a merchant of the participant's choosing. All participants will be invited to complete short, daily surveys, and will be called once per week by a research coordinator for a check in on the study's progress. All participants will be invited to the research clinic once per month. All participants will additionally receive positive messaging to reinforce positive behavior, or provide support to encourage a change in behavior.

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Washington State University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-70 years
  • Have consumed 3 or more drinks in once occasion 4 or more times in the previous 30 days 3
  • Have the ability to read and speak English
  • Have the ability to provide written informed consent
  • Have a breath alcohol value of 0.00 during informed consent
  • Owns a smartphone with an active service provider that is compatible with the study application.

Exclusion Criteria:

  • Severe alcohol use disorder that our medical staff deems too risky for safe participation;
  • Significant risk of dangerous alcohol withdrawal, defined as history of seizure due to alcohol withdrawal in the last 12 months and/or expression of concern by the participant about dangerous withdrawal
  • Anyone aged 71 or older.
  • Anyone with a suicide attempt in the last 2 years.
  • Individuals who express concern regarding dangerous withdrawal or who exhibit dangerous withdrawal symptoms.
  • Individuals who do not test BrAC = 0.00 on the breathalyzer during the baseline visit.
  • Any other condition that investigators determine a medical or psychiatric condition that would compromise safe study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Contingency Management + Treatment As Usual
An experimental approach examining the effectiveness of contingency management for promoting a decrease in drinking through increasing rewards for positive behavior. Participants will be given positive reinforcement messaging regardless of the sample's results.
Behavioral: Contingency Management
Participants in the contingent group will be rewarded on an incrementally increasing scale for submitting consecutive breathalyzer samples that are 0.00%. For every day this target is met, the participant will receive an increase in reward until a daily cap is reached. If a day contains at least one sample where the target is not met, the participant will not be paid for that day, and the amount will reset. The participant will have the opportunity to earn on this scale throughout the duration of the study.
No Intervention: Non-Contingent Management + Treatment As Usual
Participants will be given a flat amount for submitting samples on time, and there is no increasing scale for maintaining samples at 0.00%BAC. Participants will be given positive reinforcement messaging regardless of the sample's results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in days abstinent
Time Frame: 45 months
Increase in days abstinent as verified through three consecutive negative breathalyzer samples submitted at designated time slots over a period of 12 hours.
45 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington State University

Collaborators

Managed Health Connections

Investigators

  • Principal Investigator: Sterling M McPherson, PhD, Washington State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19909

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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