Mobile Peer Support for OUD Recovery

NCT05405712 | Active Not Recruiting DMC

• 2 other identifiers: 2105003009R01DA054698-01
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Opioid Use Disorder

Keywords

drug overdose; substance-related disorders; chemically-induces disorders; Fentanyl; Analgesics, opioid; Narcotics; Naloxone; Central Nervous System Depressants; Physiological Effects of Drugs; Medications for Opioid Use Disorder; Recovery; Application; Machine-learning; Mobile treatment; Natural language processing; Opioid use disorder; Peer support; Technology

Outcome Measures

Primary Outcomes (1)

• Change in the Brief Assessment of Recovery Capital (BARC-10) score over 6 month study period

  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

Study Arms (2)

Marigold APP

EXPERIMENTAL

Participants randomized to receive the APP will be enrolled in an app based peer support program

Behavioral: Mobile Phone App

CONTROL

NO INTERVENTION

In the control arm participants will receive existing standardized peer recovery support resources from SAMHSA

Interventions

Mobile Phone App BEHAVIORAL

App-based peer support program, used in conjunction with standard outpatient treatment

Also known as: Peer Recovery App

Marigold APP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking
• Age ≥ 18 years old
• Own their own smartphone
• Self-identifying as being in recovery from or treatment for an opioid use disorder

You may not qualify if:

• Does not have an Android or iOS platform smartphone
• Previous enrollment in the study
• Currently incarcerated
• Unable to provide informed consent

Sponsors & Collaborators

• Brown University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Indiana University: collaborator

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Brown University School of Public Health

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• Scherzer CR, Ranney ML, Jain S, Bommaraju SP, Patena J, Langdon K, Nimaja E, Jennings E, Beaudoin FL. Mobile Peer-Support for Opioid Use Disorders: Refinement of an Innovative Machine Learning Tool. J Psychiatr Brain Sci. 2020;5(1):e200001. doi: 10.20900/jpbs.20200001. Epub 2020 Feb 3.

  PMID: 32149192 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders; Drug Overdose; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Prescription Drug Misuse; Drug Misuse

Study Officials

• Megan Ranney, MD, MPH

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The biostatistician will be blinded to the intervention/control group assignment throughout the course of the study and the assignments. Additionally, the principal investigator will remain blinded to the randomization.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants randomized to receive the APP intervention will receive login and sign up instructions to use the Marigold Health app. Both arms will receive standardized peer recovery support resources from SAMHSA

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: June 6, 2022
• Study Start: May 12, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)