- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05405712
Mobile Peer Support for OUD Recovery (MPS)
January 28, 2026 updated by: Brown University
Increasing Peer Support for OUD Recovery During COVID-19 Through Digital Health: A National Randomized Controlled Trial
The COVID-19 pandemic puts individuals recovering from opioid use disorders (OUDs), an already vulnerable population, at increased risk of overdose due to decreased access to treatment, decreased social support, and increased psychosocial stress.
This proposal will test the efficacy of a promising mobile app-based peer support program, compared to usual care, in increasing recovery capital, improving retention in treatment, and reducing psychosocial adverse effects, among a national sample of people in recovery from OUD.
If effective, it would provide an accessible, personalized, and scalable approach to OUD recovery increasingly needed during the COVID-19 pandemic.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Increasing numbers of opioid overdoses have been observed during the COVID-19 pandemic, likely reflecting the pandemic's multiple effects on this already vulnerable population.
People in recovery from opioid use disorder (OUD) have reported disproportionate psychosocial distress and isolation, as well as significant disruptions in access to treatment including peer support, during the COVID-19 pandemic.
These negative outcomes are especially acute for rural, low-income, and minority populations in recovery from OUD. Peer support is a key component of many evidence-based OUD recovery programs: it improves recovery capital, improves treatment engagement, improves perceived social support, and reduces psychosocial distress, particularly when used in conjunction with other evidence-based treatments such as medication for opioid use disorder (MOUD).
This grant, submitted in response to PA 20-237, therefore proposes a randomized controlled trial of a novel mobile peer support app platform among a national sample of 1300 patients in recovery from opioid use disorders (OUDs), as an adjunct to usual care, during COVID-19.
The previously piloted online-only recruitment and follow-up strategy - in which investigators meld patient-reported outcomes with administrative datasets - allows strategic recruitment of often-excluded participants from across the United States, including those facing the highest barriers to treatment.
The mobile app-based peer support intervention, provided as an individual-level enhancement of existing treatment and recovery programs, will allow individuals in OUD recovery to access a tailored, anonymous, peer-moderated support group 24/7.
The app is augmented with natural language processing tools capable of automatically 'flagging' critical or clinically relevant content, thereby creating a scalable system to keep groups safe and constructive.
Participants will be followed for 6 months through both self-report and administrative outcomes.
The study's primary outcome is self-reported recovery capital, complemented by objectively measured administrative data on retention in treatment programs from our community and governmental partners in a sub-sample of 650 patients from RI and IN.
Hypothesized secondary outcomes are mitigation of psychosocial effects of COVID-19 on this vulnerable population, including depressive symptoms, stress, and loneliness, as well as objective adverse events of emergency department visits and opioid overdoses.
Finally, the investigators will explore whether state- and county-level variables moderate efficacy.
OUD is a major public health problem, and patients in recovery from OUD are experiencing worse outcomes during the COVID-19 pandemic.
If this mobile app demonstrates efficacy among a large national sample of patients, it has the potential to augment existing treatment programs, improve recovery capital, and reduce disproportionate impacts of COVID-19 on this vulnerable population.
Study Type
Interventional
Enrollment (Estimated)
1300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University
-
-
Rhode Island
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Providence, Rhode Island, United States, 02903
- Brown University School of Public Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- English-speaking
- Age ≥ 18 years old
- Own their own smartphone
- Self-identifying as being in recovery from or treatment for an opioid use disorder
Exclusion Criteria:
- Does not have an Android or iOS platform smartphone
- Previous enrollment in the study
- Currently incarcerated
- Unable to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Marigold APP
Participants randomized to receive the APP will be enrolled in an app based peer support program
|
App-based peer support program, used in conjunction with standard outpatient treatment
Other Names:
|
|
No Intervention: CONTROL
In the control arm participants will receive existing standardized peer recovery support resources from SAMHSA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Brief Assessment of Recovery Capital (BARC-10) score over 6 month study period
Time Frame: 6 months
|
This primary outcome measure will test the efficacy of app-based peer support, compared to the control, in improving recovery capital and engagement in treatment programs.
The investigators will measure a change in the Brief Assessment of Recovery Capital (BARC-10) scores, between study groups over 6 months.
The Brief Assessment of Recovery Capital will be asked at baseline, 1month follow up, 3 month follow up and 6 month follow up surveys.
This score is an abbreviated 10-item measure of recovery capital with high internal consistency.
The scale is from 1 "Strongly Disagree" to 6 "Strongly Agree."
Total scores can range from 10 to 60. Scores of 47 or higher that are sustained over time indicate higher chances of long term recovery.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Megan Ranney, MD, MPH, Brown University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 12, 2022
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
May 17, 2022
First Submitted That Met QC Criteria
June 2, 2022
First Posted (Actual)
June 6, 2022
Study Record Updates
Last Update Posted (Actual)
January 29, 2026
Last Update Submitted That Met QC Criteria
January 28, 2026
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
- Recovery
- Narcotics
- Fentanyl
- Physiological Effects of Drugs
- Naloxone
- Technology
- Opioid use disorder
- Application
- substance-related disorders
- Machine-learning
- Peer support
- Medications for Opioid Use Disorder
- Central Nervous System Depressants
- Natural language processing
- Analgesics, opioid
- drug overdose
- chemically-induces disorders
- Mobile treatment
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2105003009
- R01DA054698-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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