Alcohol Use DisorderARMS IINCT06456905
Automated Reinforcement Management Systems, Phase II
A study testing Contingency Management in people with Alcohol Use Disorder, run by Washington State University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jun 2024to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
WSU APPL Research
Spokane, Washington, 99201
Washington State University
Spokane, Washington, 99202
About this study
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Contingency Management
- Keywords
- alcohol consumption, contingency management, alcohol dependency, positive reinforcement, remote treatment, non-medicated assisted treatment, alcohol studies
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start7 Jun 2024
- Primary completion5 Sep 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- Managed Health Connections
- Responsible party
- Principal investigator, Sterling McPherson, Washington State University
- Investigators
- Sterling M McPherson, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456905
- Sponsor's protocol ID
- 19909
- Acronym
- ARMS II
- Status last verified
- Jul 2026
- First submitted
- 4 Apr 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Reinforcement Management Systems, Phase II
- ClinicalTrials.gov ID
- NCT06456905
- Acronym / sponsor ID
- ARMS II / 19909
- Conditions
- Alcohol Use Disorder
- Keywords
- alcohol consumption, contingency management, alcohol dependency, positive reinforcement, remote treatment, non-medicated assisted treatment, alcohol studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- Managed Health Connections
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management + Treatment As Usual | Experimental | Behavioral: Contingency ManagementAn 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency ManagementParticipants 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. | Behavioural | Contingency Management + Treatment As Usual |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
Related trials for Alcohol Use Disorder
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Recruiting
Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems
Alcohol Use, Adolescent
Recruiting
Peer Support for Liver Transplant Recipients With History of ALD
Alcohol Use Disorder, Alcohol Related Liver Disease
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sterling M McPherson, PhD principal investigator
Washington State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Alcohol Use Disorder, run by Washington State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in days abstinent (time frame: 45 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.