Digital Health for Opioid Use Disorder

(STAR Trial)

Overseen By Kirsten J Langdon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Must be taking: Opioid use disorder medications

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 months

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile app called Marigold can help individuals with a history of opioid use disorder, who have been in jail or prison, feel less lonely and maintain their recovery. The app connects users with peer support to enhance their chances of success after release. One group will use the Marigold app, while another will receive standard support. This trial suits those recently released from jail or prison, who have taken medication for opioid use disorder, and are interested in peer recovery support. As an unphased trial, it provides a unique opportunity to explore innovative support methods for recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using a mobile app for peer recovery support.

What prior data suggests that the Marigold Mobile Peer Support Intervention is safe?

Research has shown that the Marigold Mobile Peer Support Intervention is generally safe for people with opioid use disorder (OUD). In one study, the Marigold App, used alongside medications like buprenorphine, showed positive results without major safety issues. The app provides individuals with access to peer support at any time, which can enhance their treatment.

Another study involving adults using the app as part of their OUD treatment found it both safe and effective. These findings suggest that the Marigold App does not pose significant safety risks for users. This information may assist those considering participation in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Marigold Mobile Peer Support (MPS) intervention for opioid use disorder because it offers a fresh approach to treatment by using digital health technology. Unlike traditional methods that often rely on medication or in-person therapy, the MPS app provides peer support through a mobile platform, making it accessible anytime and anywhere. This digital method aims to enhance engagement and support for individuals, potentially leading to better adherence and outcomes. The integration of technology in this way is a new frontier in treating opioid use disorder, offering a more flexible and personalized support system.

What evidence suggests that the Marigold Mobile Peer Support Intervention is effective for opioid use disorder?

Research has shown that support from others is crucial in many successful recovery programs for opioid use disorder (OUD). In this trial, participants in the experimental arm will access the Marigold Mobile Peer Support Intervention, or Marigold App, which provides 24/7 access to a supportive community through chat groups. Studies suggest that peer support of this kind can improve recovery by keeping individuals engaged in treatment and enhancing their connection to recovery resources. Users of the Marigold App have reported better involvement in their treatment and increased support, both vital for long-term recovery. The app aims to help users manage feelings of loneliness by offering connection and support from peers who understand their experiences. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who were prescribed medication for opioid use disorder while in jail or prison, released within the last two years, and are self-reportedly recovering from OUD. They must understand English and be able to consent. If currently incarcerated, they should expect to be discharged within 3 months.

Inclusion Criteria

Anticipated discharge from jail/prison within 3 months if currently incarcerated

Self-reported recovery for an Opioid Use Disorder (OUD)

Most recently released from prison within the past two years

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive access to the Marigold Health App (MPS) intervention or enhanced treatment as usual

6 months

Baseline, 1, 3, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up interviews at 1, 3, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Marigold Mobile Peer Support Intervention

Trial Overview The study tests a mobile app called Marigold that offers peer recovery support to improve social connections and recovery outcomes for those with a history of opioid dependence after release from incarceration.

How Is the Trial Designed?

Group I: MPS App Experimental Treatment 1 Intervention

This is the experimental arm. Participants assigned to this arm will receive access to the Marigold Health App (MPS) intervention. N = 60 participants will be assigned to this arm.

Group II: Enhanced Treatment as Usual Active Control 1 Intervention

This is the active comparator arm. Participants assigned to this arm will receive enhanced treatment as usual. N = 30 participants will be assigned to this arm.

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

Published Research Related to This Trial

In a study of 180 individuals with opioid use disorders in Nairobi, Kenya, 77.2% owned mobile phones, with a high acceptability (95%) for receiving treatment via phone, particularly through text messages.

The study identified key factors influencing the acceptability of digital interventions, including education level, single marital status, smartphone ownership, and employment, which are important for designing effective digital treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone ownership, digital technology use and acceptability of digital interventions among individuals on opioid use disorder treatment in Kenya. Kiburi, SK., Paruk, S., Chiliza, B.[2022]

The MySafeRx mobile platform, which integrates motivational coaching and adherence monitoring for buprenorphine/naloxone treatment, was found to be usable and acceptable among participants, with a high mean usability score of 78.4 and positive feedback on its features.

Despite the positive reception, the study faced challenges in recruitment and did not show significant differences in outcomes between the MySafeRx group and the standard care control group, indicating that while the platform is promising, its impact on adherence and treatment success may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. Janzow, GE., Harding, C., Flores, M., et al.[2023]

A pilot study involving 58 adults in a Vermont opioid treatment program demonstrated that a video directly observed therapy (VDOT) app combined with a secure medication dispenser led to 98.4% compliance in medication ingestion, with only a minimal rate of noncompliance.

Participants experienced significant reductions in travel time and costs (86% reduction), saving a median of $72 weekly and 5.5 hours of travel time, while maintaining a high retention rate of 98% in treatment after 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing the Clinical use of a Novel Video-assisted Dosing Protocol With Secure Medication Dispensers to Reduce Barriers to Opioid Treatment. Brooklyn, JR., Stothart, M., Stunell, M., et al.[2022]

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.

Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7059630/

Mobile Peer-Support for Opioid Use Disorders The present “Marigold App” is an online peer-support platform that offers layers of innovation that are not readily available in other treatment ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05405712

NCT05405712 | Mobile Peer Support for OUD Recovery Peer support is a key component of many evidence-based OUD recovery programs: it improves recovery capital, improves treatment engagement, improves perceived ...

3. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-025-00549-y

What smartphone apps exist to support recovery from opioid ... Lastly, the app, “Marigold Health,” facilitates peer support for patients using medications for opioid use disorder (MOUD) through a text ...

4. researchgate.net researchgate.net/publication/339828335_Mobile_Peer-Support_for_Opioid_Use_Disorders_Refinement_of_an_Innovative_Machine_Learning_Tool

(PDF) Mobile Peer-Support for Opioid Use Disorders Forty adults receiving outpatient buprenorphine treatment for OUD will be asked to pilot a smartphone-based mobile peer support application, the "Marigold App", ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32149192/

Mobile Peer-Support for Opioid Use Disorders - PubMed - NIH The Marigold mobile platform will allow patients to access a tailored chat support group 24/7 as a complement to different forms of clinical OUD treatment.

6. withpower.com withpower.com/trial/phase-opioid-use-disorder-oud-4-2022-b2243

Mobile App Support for Opioid Use Disorder (MPS Trial) Another study highlighted that a digital therapeutic app used alongside medication like buprenorphine was safe and effective for people seeking treatment.