Clinical trial NCT06456905: Automated Reinforcement Management Systems, Phase II
Official title: Automated Reinforcement Management Systems, Phase II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: alcohol consumption
contingency management
alcohol dependency
positive reinforcement
remote treatment
non-medicated assisted treatment
alcohol studies
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: Managed Health Connections
First posted: 2024-06-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in days abstinent
timeFrame: 45 months
Secondary outcomes:
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Washington State University
state: Washington
Study officials:
affiliation: Washington State University
name: Sterling M McPherson, PhD
role: PRINCIPAL_INVESTIGATOR
References: