Opioid Agonist TreatmentMPOWERNCT07178990
Mobile Platform for Optimizing Wellness and Engagement in Recovery
A study testing Digital Contingency Management Intervention Arm and Digital Wellness Arm in people with Opioid Agonist Treatment and Alcohol Use Disorder, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 63 years
- Conditions the study is for
- Opioid Agonist Treatment, Alcohol Use Disorder, Opioid Use Disorder
- What is being tested?
- Digital Contingency Management Intervention Arm and Digital Wellness Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 63 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Digital Contingency Management Intervention Arm, Digital Wellness Arm
- Keywords
- Research surveys, App based program, Smartphone
- Medical subject headings
- Alcoholism, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Contingency Management Intervention ArmBehavioural
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 months after randomization.
Digital Wellness ArmBehavioural
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 approximately 9 months after randomization.
| Study group | Role | What they receive |
|---|---|---|
| Digital Contingency Management (CM) Intervention Arm | Experimental | After participants meet eligibility and complete the DynamiCare assessment period, participants randomized to this group will receive a comprehensive digital CM platform designed to enhance OAT retention and promote abstinence from alcohol and opioids. This will include the DynamiCare Motivation Support Program. Receives: Behavioral: Digital Contingency Management Intervention Arm |
| Wellness Condition | Active comparator | After participants meet eligibility and complete the DynamiCare assessment period, those randomized to this group will receive a wellness digital platform that includes surveys, testing, and tech support. Receives: Behavioral: Digital Wellness Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility based on recruitment
Recruitment: ≥60% of participants enrolled
Measured: Recruitment period 12 months
Feasibility based on adherence
Adherence: ≥50% of app-based, biochemically-verified tests completed in the digital CM condition.
Measured: 6 months (during the Dynamicare program)
Feasibility based on Retention
Retention: ≥70% of participants retained at 6 months
Measured: 6 months
Acceptability of the intervention
Defined as >70% of participants rating the intervention experience ≥ 4/5 on the Acceptability of Intervention Measure
Measured: 3-month after starting program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start8 Dec 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Agonist TreatmentStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), DynamiCare Health
- Responsible party
- Principal investigator, Lara Coughlin, University of Michigan
- Investigators
- Lara Coughlin, PhD, Principal investigator, University of MichiganAnne C Fernandez, PhD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178990
- Sponsor's protocol ID
- HUM00266546
- Other IDs
- 1R34AA031870-01
- Acronym
- MPOWER
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded investigators conducting applicable human subjects research are expected to submit de-identified, individual-level data to this data archive. The data generated in this grant will also be presented at national or international meetings (e.g., Research Society on Alcoholism, Addiction Health Services Research, etc.) and published in a timely fashion. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive in PubMed Central.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Platform for Optimizing Wellness and Engagement in Recovery
- ClinicalTrials.gov ID
- NCT07178990
- Acronym / sponsor ID
- MPOWER / HUM00266546
- Keywords
- Research surveys, App based program, Smartphone
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), DynamiCare Health
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 17 Sep 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Contingency Management (CM) Intervention Arm | Experimental | Behavioral: Digital Contingency Management Intervention ArmAfter participants meet eligibility and complete the DynamiCare assessment period, participants randomized to this group will receive a comprehensive digital CM platform designed to enhance OAT retention and promote abstinence from alcohol and opioids. This will include the DynamiCare Motivation Support Program. |
| Wellness Condition | Active comparator | Behavioral: Digital Wellness ArmAfter participants meet eligibility and complete the DynamiCare assessment period, those randomized to this group will receive a wellness digital platform that includes surveys, testing, and tech support. |
Who may qualify
- Ages
- 19 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Digital Contingency Management Intervention ArmParticipants 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 months after randomization. | Behavioural | Digital Contingency Management (CM) Intervention Arm |
| Digital Wellness ArmParticipants 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 approximately 9 months after randomization. | Behavioural | Wellness Condition |
Primary outcome
Feasibility based on recruitment
Time frame: Recruitment period 12 months
Recruitment: ≥60% of participants enrolled
Feasibility based on adherence
Time frame: 6 months (during the Dynamicare program)
Adherence: ≥50% of app-based, biochemically-verified tests completed in the digital CM condition.
Feasibility based on Retention
Time frame: 6 months
Retention: ≥70% of participants retained at 6 months
Acceptability of the intervention
Time frame: 3-month after starting program
Defined as >70% of participants rating the intervention experience ≥ 4/5 on the Acceptability of Intervention Measure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded investigators conducting applicable human subjects research are expected to submit de-identified, individual-level data to this data archive. The data generated in this grant will also be presented at national or international meetings (e.g., Research Society on Alcoholism, Addiction Health Services Research, etc.) and published in a timely fashion. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive in PubMed Central.
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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.
Lara Coughlin, PhD principal investigator
University of Michigan
Anne C Fernandez, PhD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Contingency Management Intervention Arm and Digital Wellness Arm in people with Opioid Agonist Treatment and Alcohol Use Disorder, run by University of Michigan at 1 site 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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility based on recruitment (time frame: Recruitment period 12 months). The study lists 4 primary outcomes in all. 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 2 Oct 2026.