NCT07178990

Brief 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. The study aims to evaluate the feasibility and acceptability of digital CM for OUD-AUD recovery, while also planning for broader implementation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Dec 2025Jul 2027

First Submitted

Initial submission to the registry

September 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 8, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

May 6, 2026

Status Verified

December 1, 2025

Enrollment Period

1.6 years

First QC Date

September 10, 2025

Last Update Submit

May 1, 2026

Conditions

Keywords

Research surveysApp based programSmartphone

Outcome Measures

Primary Outcomes (4)

  • Feasibility based on recruitment

    Recruitment: ≥60% of participants enrolled

    Recruitment period 12 months

  • Feasibility based on adherence

    Adherence: ≥50% of app-based, biochemically-verified tests completed in the digital CM condition.

    6 months (during the Dynamicare program)

  • Feasibility based on Retention

    Retention: ≥70% of participants retained at 6 months

    6 months

  • Acceptability of the intervention

    Defined as \>70% of participants rating the intervention experience ≥ 4/5 on the Acceptability of Intervention Measure

    3-month after starting program

Study Arms (2)

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.

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.

Behavioral: Digital Wellness Arm

Interventions

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.

Wellness Condition

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 Contingency Management (CM) Intervention Arm

Eligibility Criteria

Age19 Years - 63 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

AlcoholismOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Study Officials

  • Lara Coughlin, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR
  • Anne C Fernandez, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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
Associate Professor of Psychiatry

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 17, 2025

Study Start

December 8, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

May 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The research team will share data with NIAAA data archive (NIAAADA) biannually per funder requirements. The data in the NIAAADA are catalogued and made available to the general research community at the time of an associated publication or end of the award/support period, whichever comes first. Data in the NIAAADA is available indefinitely.
Access Criteria
Community of scientists interested in the study of alcohol use and related interventions. Additionally, data submitted to National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) will be accessible by the general research community via NIAAADA.
More information

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