NCT04656925: ARMS

Automated Reinforcement Management System (ARMS)

Completed NA Results posted Last updated 5 February 2025

What this trial tests

NA trial testing Contingency management in Alcohol Use Disorder in 12 participants. Completed in 8 December 2021.

Timeline

29 March 2021

Primary endpoint
8 December 2021

8 December 2021

Quick facts

Lead sponsor	Washington State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	29 March 2021
Primary completion	8 December 2021
Estimated completion	8 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Contingency management

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

Washington State University

Who can join

Adults 18 to 65, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Biochemically Measured Change in Alcohol Abstinence. Primary · Daily during 8 weeks (2 weeks of first A phase, 4 weeks of B phase, and 2 second A phase)

Change in biochemically measured alcohol abstinence assessed through breath samples submitted three times daily.

First A Phase

Group	Value	95% CI
Contingency Management A-B-A	347

B Phase

Group	Value	95% CI
Contingency Management A-B-A	615

Second A Phase

Group	Value	95% CI
Contingency Management A-B-A	209

Feasibility Indicator of App Usage Secondary · 8 weeks (2 weeks of first A phase, 4 weeks of B phase, and 2 second A phase)

Percentage of actual BAC samples submitted by the total number of possible submissions.

First A Phase

Group	Value	95% CI
Contingency Management A-B-A	411

B Phase

Group	Value	95% CI
Contingency Management A-B-A	700

Second A Phase

Group	Value	95% CI
Contingency Management A-B-A	249

Treatment Retention Secondary · 8 Weeks

Duration in weeks of treatment retention

Group	Value	95% CI
Contingency Management A-B-A	7.5	± 1.1

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

First A Phase

Serious: 0/12 (0%)

Deaths: 0/12

B Phase

Serious: 0/12 (0%)

Deaths: 0/12

Second A Phase

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (4 terms — click to expand)

Reaction	System	First A Phase	B Phase	Second A Phase
Kidney Pain	Renal and urinary disorders	—	—	—
Mild headache	Nervous system disorders	—	—	—
Sleep apnea	Respiratory, thoracic and mediastinal disorders	—	—	—
Shoulder pain	Musculoskeletal and connective tissue disorders	—	—	—

Data from ClinicalTrials.gov NCT04656925 adverse events section.

Sponsor's own description

Alcohol abuse remains a significant cause of preventable morbidity and mortality in the US. Yet only 15% of those with alcohol use disorders receive treatment. Contingency Management (CM) is a cost-effective intervention for drug addiction where individuals are rewarded when they submit biological verification of drug abstinence. The researchers propose to develop an integrated CM system capable of incorporating mobile device input, that would allow them to deliver a CM intervention for problematic drinking to anyone who owns a smartphone. The mobile device input will incorporate ecological momentary assessments (EMA), geospatial mapping, and biomarker-based feedback from a portable measuring device.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.