LonelinessSTARNCT06896656
Improving Social Connectedness Through Digital Health to Enhance Recovery From OUD Among the Justice Involved Population
A study testing Marigold Mobile Peer Support Intervention and Resources in people with Loneliness and Opioid Use Disorder, run by Rhode Island Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Loneliness, Opioid Use Disorder
- What is being tested?
- Marigold Mobile Peer Support Intervention and Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years of age
- history of being prescribed medication for opioid use disorder (MOUD) while in jail or prison
- most recently released from prison with the past two years
- self-reported recovery for an Opioid Use Disorder (OUD)
- able to understand and speak English and to provide written and verbal consent
- anticipated discharge from jail/prison within 3 months if currently incarcerated
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
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.
Read the detailed description
Individuals with criminal justice involvement experience elevated rates of Opioid Use Disorder (OUD) and are at significantly higher risk of death from opioid overdose in the first year following release from jail/prison. Medications for OUD (MOUD) are an evidence-based approach to treating OUD and offer extensive benefits including lowering rates of mortality, illicit opioid use, HIV transmission, violent crime, and arrest. While many correctional settings have started to implement MOUD, there are significant challenges to continuing medication/treatment while transitioning back to the community. Intersectional stigma related to addiction and history of incarceration is associated with greater difficulties with reintegration, increased isolation, and heightened feelings of loneliness. Lack of social connectedness further serves as a risk factor for decreased retention in treatment, discontinuation of MOUD, and a return to substance use. Peer support is a key component of many evidence-based OUD recovery programs. When used in conjunction with MOUD, it has the potential to improve perceived social support, self-efficacy, and treatment engagement. However, access to live peer support has been challenged by COVID restrictions, highlighting a critical need for digital health platforms to deliver peer support. The Marigold Mobile Peer Support ("MPS") App is a dedicated, secure, mobile application that employs structured, live peer moderation to guide text-based conversations with groups of participants and behind-the-scenes natural language processing (NLP) to automatically identify "red flag" content within peer chats. While initial work demonstrates the utility of deploying the MPS App in outpatient treatment settings for OUD, it has yet to be tested in correctional settings or among justice-involved populations. The goal of the proposed application is to advance evidence-based and scalable treatments for OUD, by decreasing loneliness and enhancing perceived social support via novel application of an established mobile app among individuals with a history of engaging in MOUD while in jail/prison. The study will be accomplished through two primary aims: (1) develop an implementation manual to guide delivery of the MPS App for those with a recent (past year) history of engaging in MOUD while in jail/prison by conducting in-depth interviews with prospective app users and other key stakeholders; and (2) conduct a randomized controlled trial to assess feasibility, acceptability, and preliminary efficacy of the MPS App relative to enhanced treatment-as-usual among individuals with a recent (past year) history of engaging in MOUD while in jail/prison. Findings from this study will be used to develop a R01 application to conduct a fully-powered Hybrid Type 1 Effectiveness-Implementation study.
- Conditions
- Loneliness, Opioid Use Disorder
- Being tested
- Marigold Mobile Peer Support Intervention, Resources
- Keywords
- Mobile Health
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marigold Mobile Peer Support InterventionBehavioural
The MPS App is a secure platform that allows text-based peer support for individuals in recovery from OUD. Participants assigned to this condition will be enrolled on a rolling basis into a peer support group on the app. All participants will receive onboarding assistance and will have access to the app for 6 months.
The app will include live moderation from a certified Peer Recovery Support Specialist and trained research assistants. Moderators will begin discussions with prompts and regulate the flow of conversation with standardized text language. Moderators will be able to respond in real-time to malicious messages or other "flags" that could impact participant safety. Built in natural language processing algorithms will also detect language requiring intervention and automatically alter the moderators and on-call clinicians.
ResourcesBehavioural
A list of online peer support and mental health resources, drawn from SAMSHA and equivalent websites, will be provided to all participants, as an enhanced adjunct to their standard recovery plans.
| Study group | Role | What they receive |
|---|---|---|
| MPS App | Experimental | 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. Receives: Behavioral: Marigold Mobile Peer Support Intervention |
| Enhanced Treatment as Usual | Active comparator | 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. Receives: Behavioral: Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Support
Perceived social support will be assessed with the Multidimensional Scale of Perceived Social Support (MSPSS). This assessment is psychometrically sound, with adequate reliability and validity, and measures perceived social support from family, friends, and significant others among adults. Scores are averaged and range from 1 to 7, with 1 signifying the lowest level of social support and 7 signifying the highest.
Measured: Baseline, 1, 3, and 6 months.
Loneliness
Loneliness will be assessed with the 20-item UCLA Loneliness scale. Scores range from 20 to 80, where higher scores indicate greater loneliness.
Measured: Baseline, 1, 3, and 6 months.
Secondary outcomes (2)
Substance Use
Self-reported substance use will be assessed with the Timeline Follow-Back interview and biochemically confirmed with Urine Drug Screens. Substance use will be operationalized as the percentage of days positive for drug use (separate by drug class) in between assessments.
Measured: Baseline, 1, 3, and 6 months.
Engagement in Medications for Opioid Use Disorder (MOUD)
Self-reported engagement in MOUD will be assessed with a Timeline Follow-Back interview and biochemically confirmed with Urine Drug Screens. Engagement in MOUD will be operationalized as the percentage of days positive for MOUD administration in between assessments.
Measured: Baseline, 1, 3, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start17 Mar 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896656
- Sponsor's protocol ID
- 1R34DA058299
- Acronym
- STAR
- Status last verified
- May 2026
- First submitted
- 12 Mar 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Social Connectedness Through Digital Health to Enhance Recovery From OUD Among the Justice Involved Population
- ClinicalTrials.gov ID
- NCT06896656
- Acronym / sponsor ID
- STAR / 1R34DA058299
- Conditions
- Loneliness, Opioid Use Disorder
- Keywords
- Mobile Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Individuals with criminal justice involvement experience elevated rates of Opioid Use Disorder (OUD) and are at significantly higher risk of death from opioid overdose in the first year following release from jail/prison. Medications for OUD (MOUD) are an evidence-based approach to treating OUD and offer extensive benefits including lowering rates of mortality, illicit opioid use, HIV transmission, violent crime, and arrest. While many correctional settings have started to implement MOUD, there are significant challenges to continuing medication/treatment while transitioning back to the community. Intersectional stigma related to addiction and history of incarceration is associated with greater difficulties with reintegration, increased isolation, and heightened feelings of loneliness. Lack of social connectedness further serves as a risk factor for decreased retention in treatment, discontinuation of MOUD, and a return to substance use. Peer support is a key component of many evidence-based OUD recovery programs. When used in conjunction with MOUD, it has the potential to improve perceived social support, self-efficacy, and treatment engagement. However, access to live peer support has been challenged by COVID restrictions, highlighting a critical need for digital health platforms to deliver peer support. The Marigold Mobile Peer Support ("MPS") App is a dedicated, secure, mobile application that employs structured, live peer moderation to guide text-based conversations with groups of participants and behind-the-scenes natural language processing (NLP) to automatically identify "red flag" content within peer chats. While initial work demonstrates the utility of deploying the MPS App in outpatient treatment settings for OUD, it has yet to be tested in correctional settings or among justice-involved populations. The goal of the proposed application is to advance evidence-based and scalable treatments for OUD, by decreasing loneliness and enhancing perceived social support via novel application of an established mobile app among individuals with a history of engaging in MOUD while in jail/prison. The study will be accomplished through two primary aims: (1) develop an implementation manual to guide delivery of the MPS App for those with a recent (past year) history of engaging in MOUD while in jail/prison by conducting in-depth interviews with prospective app users and other key stakeholders; and (2) conduct a randomized controlled trial to assess feasibility, acceptability, and preliminary efficacy of the MPS App relative to enhanced treatment-as-usual among individuals with a recent (past year) history of engaging in MOUD while in jail/prison. Findings from this study will be used to develop a R01 application to conduct a fully-powered Hybrid Type 1 Effectiveness-Implementation study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPS App | Experimental | Behavioral: Marigold Mobile Peer Support InterventionThis 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. |
| Enhanced Treatment as Usual | Active comparator | Behavioral: ResourcesThis 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18+ years of age
- history of being prescribed medication for opioid use disorder (MOUD) while in jail or prison
- most recently released from prison with the past two years
- self-reported recovery for an Opioid Use Disorder (OUD)
- able to understand and speak English and to provide written and verbal consent
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marigold Mobile Peer Support InterventionThe MPS App is a secure platform that allows text-based peer support for individuals in recovery from OUD. Participants assigned to this condition will be enrolled on a rolling basis into a peer support group on the app. All participants will receive onboarding assistance and will have access to the app for 6 months. The app will include live moderation from a certified Peer Recovery Support Specialist and trained research assistants. Moderators will begin discussions with prompts and regulate the flow of conversation with standardized text language. Moderators will be able to respond in real-time to malicious messages or other "flags" that could impact participant safety. Built in natural language processing algorithms will also detect language requiring intervention and automatically alter the moderators and on-call clinicians. | Behavioural | MPS App |
| ResourcesA list of online peer support and mental health resources, drawn from SAMSHA and equivalent websites, will be provided to all participants, as an enhanced adjunct to their standard recovery plans. | Behavioural | Enhanced Treatment as Usual |
Primary outcome
Social Support
Time frame: Baseline, 1, 3, and 6 months.
Perceived social support will be assessed with the Multidimensional Scale of Perceived Social Support (MSPSS). This assessment is psychometrically sound, with adequate reliability and validity, and measures perceived social support from family, friends, and significant others among adults. Scores are averaged and range from 1 to 7, with 1 signifying the lowest level of social support and 7 signifying the highest.
Loneliness
Time frame: Baseline, 1, 3, and 6 months.
Loneliness will be assessed with the 20-item UCLA Loneliness scale. Scores range from 20 to 80, where higher scores indicate greater loneliness.
2 secondary outcomes
Substance Use
Time frame: Baseline, 1, 3, and 6 months.
Engagement in Medications for Opioid Use Disorder (MOUD)
Time frame: Baseline, 1, 3, and 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marigold Mobile Peer Support Intervention and Resources in people with Loneliness and Opioid Use Disorder, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Support (time frame: Baseline, 1, 3, and 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.