Menu
Recruiting NCT07178990

Mobile Platform for Optimizing Wellness and Engagement in Recovery

No phase Interventional Opioid Agonist Treatment Alcohol Use Disorder Opioid Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital Contingency Management Intervention Arm, Digital Wellness Arm.
Who it may be relevant to
Registry conditions: Opioid Agonist Treatment, Alcohol Use Disorder, Opioid Use Disorder. Basic parameters: 19 years — 63 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This pilot study addresses the urgent public health crisis of co-occurring opioid and alcohol use disorders (OUD-AUD), leading causes of mortality in the United States, by testing a scalable digital contingency management (CM) treatment among Medicaid beneficiaries. The study aims to evaluate the feasibility and acceptability of digital CM for OUD-AUD recovery, while also planning for broader implementation.

Interventions

  • Behavioral Digital Contingency Management Intervention Arm
    Participants will use a version of the app for 6-months. Participants in this group may earn rewards for completing recovery-related activities and for abstinence from drugs and alcohol. During the 6 months this will include: random saliva drug tests, breathalyzer tests, and video selfies, completing surveys and questionnaires through the app, and receiving rewards on a debit card for abstinent tests, surveys, and activities. Additionally, participants will complete follow-up at approximately 9
  • Behavioral Digital Wellness Arm
    Participants will use a version of the app for 6-months focussed on wellness. During the 6 months this will include: random requests to do saliva drug tests, breathalyzer tests, and video selfies, complete surveys and questionnaires through the app, and receive rewards on a debit card for completing tests, surveys, and activities. Participants in this group may also earn rewards for completing study activities like tests and surveys. Additionally, participants will complete follow-up at approxim

Primary outcome measures

  • Feasibility based on recruitment [Time frame: Recruitment period 12 months]
  • Feasibility based on adherence [Time frame: 6 months (during the Dynamicare program)]
  • Feasibility based on Retention [Time frame: 6 months]
  • Acceptability of the intervention [Time frame: 3-month after starting program]

Eligibility criteria

Inclusion criteria

  • Participants must be enrolled in the Michigan Medicaid program
  • Opioid agonist treatment (OAT): Participants must have initiated OAT with buprenorphine or methadone
  • Participants must have an OAT prescription and Alcohol use disorder (AUD) based on self-report measure during screening
  • Participants must have regular access to a working smartphone and internet connection.
  • Participants must have a reliable mailing address to receive study supplies (e.g., salivary drug tests).

Exclusion criteria

  • Primary Medicare Coverage: Individuals that are dual-eligible for Medicaid and Medicare and aged 65 or older, due to limited availability of Medicaid claims data for this group
  • Individuals that cannot voluntarily provide informed consent themselves for any reason, including legal incompetency
  • Individuals with substantial cognitive impairment that would interfere with study participation
  • Individuals unable to read or understand English
  • Individuals experiencing active suicidality or psychosis.
  • Individuals with a planned admission to residential treatment or incarceration during the study period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT07178990 · HUM00266546 · 1R34AA031870-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗