Opioid Use DisorderNCT06384781
STAMPS: South Carolina Buprenorphine Treatment Initiation, Adherence, and Retention Utilizing Mobile Health Units and Peer Support Specialists
A study testing Peer Support Checklist in people with Opioid Use Disorder, run by Prisma Health-Upstate at 2 sites in United States.
Trial summary
The study is a 1-arm prospective interventional cohort quasi-experimental with retrospective control group. Enrolled participants will be compared to previously established mobile health patients, who did not work with a peer recovery coach, for buprenorphine treatment and adherence outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Peer Support Checklist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 May 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18+
- Have diagnosis of OUD
- New patient of the mobile clinic
Who cannot join
- Currently prescribed MOUD
- Currently working with a PSS
- Current suicidal ideation, as verified through the Patient Health Questionnaire-9 (PHQ-9)
- Having a severe medical or psychiatric disability that would hinder participation in the study, as determined by nurse practitioner
- Unable to read/speak English
- Unable to read and comprehend the consent materials and other study materials
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Prisma Addiction Medicine Center - Mobile Health Clinic
Clinton, South Carolina, 29325
Prisma - Addiction Medicine Center Mobile Health Clinic
Seneca, South Carolina, 29672
About this study
Official title: Development, Refinement, and Validation of a Peer Support Specialist Checklist for Individuals With Opioid Use Disorder / STAMPS: South Carolina Buprenorphine Treatment Initiation, Adherence, and Retention Utilizing Mobile Health Units and Peer Support Specialists
The study is a 1-arm prospective interventional cohort quasi-experimental with retrospective control group. Enrolled participants will be compared to previously established mobile health patients, who did not work with a peer recovery coach, for buprenorphine treatment and adherence outcomes. 90 patients will be recruited from the mobile health units in rural counties in Upstate South Carolina. Visits consist of a baseline and 3 month follow up.
The study will focus to develop, deliver, and evaluate an innovative 1) Peer Support Specialist (PSS) intervention to increase Medications for Opioid Use Disorder (MOUD) initiation and retention rates in rural populations and underserved communities, and 2) dynamic modeling framework to prioritize at-risk communities for delivery of Mobile Health Clinics. the interventions will be developed in the R61 phase and implemented in a pilot study to determine the effectiveness on initiation and retention. With opioid overdose deaths continuing to rise in South Carolina (SC) and nationally, our sustainable framework has potential to prevent hundreds to thousands of opioid overdoses in SC and can be scaled up in other regions to save many more lives.
Read the detailed description
Over 100,000 lives were lost due to drug overdose in the past year, of which 80% involved opioids.The majority of opioid-related deaths were due to fentanyl, an illicit opioid that has been labeled the single deadliest drug threat ever encountered in the United States.With opioid overdose deaths doubling in the past two years, there are no current signs that the epidemic is slowing down. Despite the effectiveness of medications for opioid use disorder (MOUD) at reducing opioid use, only 10% of those in need receive treatment. Furthermore, treatment retention is low (30-50%). Low treatment initiation and retention rates for Opioid Use Disorder (OUD) are especially concerning for rural and underserved communities, who rarely have access to clinicians prescribing MOUD and experience substantial barriers to care, including lack of insurance, social isolation, homelessness, transportation issues, and stigma. Given these populations are also at an elevated risk of overdose due to many of these same factors,interventions to increase MOUD initiation, retention, and overdose prevention in rural and underserved communities are urgently needed.
Our proposal aims to improve medication for opioid use disorder (MOUD) treatment rates and prevent overdose deaths in underserved communities using mobile health clinics (MHC). This will be achieved by developing, testing, delivering, and evaluating two key components: 1) a Peer Support Specialist (PSS) intervention to enhance MOUD initiation and retention, and 2) a modeling framework to identify high-risk communities for MHC delivery of opioid use disorder (OUD) interventions, based on the prevention of overdose deaths in those areas. Previous research has shown that such modeling tools can significantly enhance the efficiency of resource allocation across different health issues.
In the initial R61 phase, we will develop the PSS intervention and modeling framework.
The primary goal of aim 1 in the R61 phase is to assess the early fidelity, acceptability, and effectiveness of the PSS Service Delivery in boosting MOUD initiation and retention in rural and underserved populations. This intervention will draw from the successful assertive community engagement (ACE) model PSS interventions for substance use disorders and will be crafted based on qualitative interviews with PSS and OUD patients, as well as pilot data.
- Conditions
- Opioid Use Disorder
- Being tested
- Peer Support Checklist
- Keywords
- peer support specialist, peer recovery coach, OUD, opioid use disorder, mobile health clinic, rural
- 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.
Peer Support ChecklistBehavioural
Peer support specialists are Certified Peer Support Specialists (CPSS) who have lived experience with Opioid Use Disorder (OUD) and OUD recovery. Peer support specialists offer consistent personalized recovery support and generalized social support. Peer support specialists will maintain contact and provide support for the participant for six-months post-baseline. CPSS will utilize the newly developed checklist from earlier phases of the project to provide patient support.
| Study group | Role | What they receive |
|---|---|---|
| Peer Support Specialist Intervention | Experimental | Eligible participants will be linked to a peer support specialist. Peer support specialists are Certified Peer Support Specialists (CPSS) who have lived experience with opioid use disorder (OUD) and OUD recovery. Peer support specialists offer consistent personalized recovery support and generalized social support. Peer support specialists will maintain contact and provide support for the participant for 3 months post-baseline utilizing the newly validated checklist. Receives: Behavioral: Peer Support Checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Initiating MOUD
MOUD initiation is defined as receipt of of two or more MOUD prescription within the 3-month study period
Measured: 90 days
Number of Participants Retained in MOUD Care
MOUD retention is defined as receipt of 80% of MOUD prescriptions in first 3 months since MOUD initiation and MOUD coverage on day 90
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start2 May 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid Use DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Clemson University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384781
- Sponsor's protocol ID
- 2130836
- Other IDs
- R61DA059892-01
- Status last verified
- Aug 2026
- First submitted
- 22 Apr 2024
- Last updated
- 23 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Refinement, and Validation of a Peer Support Specialist Checklist for Individuals With Opioid Use Disorder / STAMPS: South Carolina Buprenorphine Treatment Initiation, Adherence, and Retention Utilizing Mobile Health Units and Peer Support Specialists
- ClinicalTrials.gov ID
- NCT06384781
- Acronym / sponsor ID
- 2130836
- Conditions
- Opioid Use Disorder
- Keywords
- peer support specialist, peer recovery coach, OUD, opioid use disorder, mobile health clinic, rural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Clemson University, National Institute on Drug Abuse (NIDA)
- Study start
- 2 May 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Posted 23 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a 1-arm prospective interventional cohort quasi-experimental with retrospective control group. Enrolled participants will be compared to previously established mobile health patients, who did not work with a peer recovery coach, for buprenorphine treatment and adherence outcomes. 90 patients will be recruited from the mobile health units in rural counties in Upstate South Carolina. Visits consist of a baseline and 3 month follow up.
The study will focus to develop, deliver, and evaluate an innovative 1) Peer Support Specialist (PSS) intervention to increase Medications for Opioid Use Disorder (MOUD) initiation and retention rates in rural populations and underserved communities, and 2) dynamic modeling framework to prioritize at-risk communities for delivery of Mobile Health Clinics. the interventions will be developed in the R61 phase and implemented in a pilot study to determine the effectiveness on initiation and retention. With opioid overdose deaths continuing to rise in South Carolina (SC) and nationally, our sustainable framework has potential to prevent hundreds to thousands of opioid overdoses in SC and can be scaled up in other regions to save many more lives.
Detailed description
Over 100,000 lives were lost due to drug overdose in the past year, of which 80% involved opioids.The majority of opioid-related deaths were due to fentanyl, an illicit opioid that has been labeled the single deadliest drug threat ever encountered in the United States.With opioid overdose deaths doubling in the past two years, there are no current signs that the epidemic is slowing down. Despite the effectiveness of medications for opioid use disorder (MOUD) at reducing opioid use, only 10% of those in need receive treatment. Furthermore, treatment retention is low (30-50%). Low treatment initiation and retention rates for Opioid Use Disorder (OUD) are especially concerning for rural and underserved communities, who rarely have access to clinicians prescribing MOUD and experience substantial barriers to care, including lack of insurance, social isolation, homelessness, transportation issues, and stigma. Given these populations are also at an elevated risk of overdose due to many of these same factors,interventions to increase MOUD initiation, retention, and overdose prevention in rural and underserved communities are urgently needed.
Our proposal aims to improve medication for opioid use disorder (MOUD) treatment rates and prevent overdose deaths in underserved communities using mobile health clinics (MHC). This will be achieved by developing, testing, delivering, and evaluating two key components: 1) a Peer Support Specialist (PSS) intervention to enhance MOUD initiation and retention, and 2) a modeling framework to identify high-risk communities for MHC delivery of opioid use disorder (OUD) interventions, based on the prevention of overdose deaths in those areas. Previous research has shown that such modeling tools can significantly enhance the efficiency of resource allocation across different health issues.
In the initial R61 phase, we will develop the PSS intervention and modeling framework.
The primary goal of aim 1 in the R61 phase is to assess the early fidelity, acceptability, and effectiveness of the PSS Service Delivery in boosting MOUD initiation and retention in rural and underserved populations. This intervention will draw from the successful assertive community engagement (ACE) model PSS interventions for substance use disorders and will be crafted based on qualitative interviews with PSS and OUD patients, as well as pilot data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer Support Specialist Intervention | Experimental | Behavioral: Peer Support ChecklistEligible participants will be linked to a peer support specialist. Peer support specialists are Certified Peer Support Specialists (CPSS) who have lived experience with opioid use disorder (OUD) and OUD recovery. Peer support specialists offer consistent personalized recovery support and generalized social support. Peer support specialists will maintain contact and provide support for the participant for 3 months post-baseline utilizing the newly validated checklist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18+
- Have diagnosis of OUD
- New patient of the mobile clinic
Key exclusion criteria (6 listed)
- Currently prescribed MOUD
- Currently working with a PSS
- Current suicidal ideation, as verified through the Patient Health Questionnaire-9 (PHQ-9)
- Having a severe medical or psychiatric disability that would hinder participation in the study, as determined by nurse practitioner
- Unable to read/speak English
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 |
|---|---|---|
| Peer Support ChecklistPeer support specialists are Certified Peer Support Specialists (CPSS) who have lived experience with Opioid Use Disorder (OUD) and OUD recovery. Peer support specialists offer consistent personalized recovery support and generalized social support. Peer support specialists will maintain contact and provide support for the participant for six-months post-baseline. CPSS will utilize the newly developed checklist from earlier phases of the project to provide patient support. | Behavioural | Peer Support Specialist Intervention |
Primary outcome
Number of Participants Initiating MOUD
Time frame: 90 days
MOUD initiation is defined as receipt of of two or more MOUD prescription within the 3-month study period
Number of Participants Retained in MOUD Care
Time frame: 90 days
MOUD retention is defined as receipt of 80% of MOUD prescriptions in first 3 months since MOUD initiation and MOUD coverage on day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH RePORTERLink provided by the sponsor.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Support Checklist in people with Opioid Use Disorder, run by Prisma Health-Upstate at 2 sites 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 23 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Initiating MOUD (time frame: 90 days). 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 23 Sep 2026.