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

Trial Summary

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 data supports the effectiveness of the Marigold Mobile Peer Support Intervention treatment for opioid use disorder?

Research shows that digital therapeutic tools, like mobile apps, can help people understand and stick with medication-assisted treatment for opioid use disorder. These tools are low-cost and can improve knowledge about treatment, which is often a barrier to starting and continuing care. ^{1 2 3 4 5}

Is the Marigold Mobile Peer Support Intervention safe for humans?

The research on digital health tools for opioid use disorder, including mobile apps and digital therapeutics, suggests they are generally safe for humans. These tools have been used to support treatment adherence and provide health information without reported safety concerns. ^{2 3 4 5 6}

What makes the Marigold Mobile Peer Support Intervention treatment unique for opioid use disorder?

The Marigold Mobile Peer Support Intervention is unique because it uses a digital platform to provide peer support, which can be more accessible and cost-effective compared to traditional in-person treatments. This approach can help overcome barriers to treatment entry by offering support and information through a mobile app, making it easier for individuals to engage with their recovery process. ^{1 2 3 4 6}

What is the purpose of this trial?

People with a history of Opioid Use Disorder and criminal justice involvement are more likely to experience loneliness following release from jail/prison leading to negative outcomes such as treatment dropout and increased substance use. Providing peer recovery support, particularly through a highly accessible, digital health platform, is a potential way to decrease loneliness in this population. The current study seeks to test whether a mobile peer recovery support app, delivered to individuals with a recent history of taking medication for opioid use disorder while in jail/prison, will improve outcomes for this vulnerable population.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Switzerland 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Prospective acceptability of digital phenotyping among pregnant and parenting people with opioid use disorder: A multisite qualitative study. [2023]

5. Netherlands 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. [2022]

6. Netherlands 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. [2023]