Automated Reinforcement Management Systems, Phase II

NCT06456905 | Recruiting

• 1 other identifier: 19909
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

alcohol consumption; contingency management; alcohol dependency; positive reinforcement; remote treatment; non-medicated assisted treatment; alcohol studies

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Contingency Management + Treatment As Usual

EXPERIMENTAL

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

Non-Contingent Management + Treatment As Usual

NO INTERVENTION

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.

Interventions

Contingency Management BEHAVIORAL

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.

Contingency Management + Treatment As Usual

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington State University: lead
• Managed Health Connections: collaborator

Study Sites (1)

Washington State University

Spokane, Washington, 99202, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Study Officials

• Sterling M McPherson, PhD

  Washington State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail L Bowen, MS

CONTACT

(425) 736-1354; abigail.bowen@wsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: June 13, 2024
• Study Start: June 7, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

US (1)