Clinical trial NCT05405712: Mobile Peer Support for OUD Recovery
Official title: Increasing Peer Support for OUD Recovery During COVID-19 Through Digital Health: A National Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
name: Indiana University
First posted: 2022-06-06
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Brief Assessment of Recovery Capital (BARC-10) score over 6 month study period
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Providence
country: United States
facility: Brown University School of Public Health
state: Rhode Island
Study officials:
affiliation: Brown University
name: Megan Ranney, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.