Automated Reinforcement Management Systems, Phase II

Alcohol Use Disorder Clinical Trial

— ARMS II  

Official title:

Automated Reinforcement Management Systems, Phase II

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06456905
• Other study ID #: 19909
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: June 2024
• Source: Washington State University
• Contact: Abigail L Bowen, MS
• Phone: (425) 736-1354
• Email: abigail.bowen[@]wsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 (less than 0.08) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Contingency Management
Participants in the contingent group will be rewarded on an incrementally increasing scale for submitting consecutive breathalyzer samples that are less than 0.08%. 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.

Locations

Country	Name	City	State
United States	Washington State University	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Washington State University	Managed Health Connections

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in days abstinent	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