Opioid Use DisorderTHRIVENCT06843213
Teaching Health Resilience in a Hospital Setting: A Peer-led Intervention
A study testing Peer Intervention in people with Opioid Use Disorder and Harm Reduction, run by University of Pennsylvania at 3 sites in United States.
Trial summary
The purpose of the study is to develop an acceptable, feasible, and effective peer-led bundle of health resilience and promotion services to be delivered in the hospital setting, called the THRIVE intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Harm Reduction, Health Promotion
- What is being tested?
- Peer Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Feb 2025to 1 Aug 2028
- 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
- Participants who are: a) admitted to University of Pittsburgh Medical Center (UPMC) Shadyside Hospital, UPMC Presbyterian-Montefiore Hospital, UPMC Mercy Hospital for inpatient or observation status, or b) seen in the Emergency Department setting at UPMC Presbyterian-Montefiore Hospital and UPMC Mercy Hospital.
- Participants must have a current diagnosis of Opioid Use Disorder based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria.
- Participants must be at least 18 years of age on day of admission.
- Participants must be able to speak and read English.
Who cannot join
- Participants diagnosed with dementia and/or cognitive impairments.
- Participants with acute psychiatric complications, such as schizophrenia with acute psychosis, acute mania, or suicidal ideation (which may impact the ability of a participant to consent and actively participate in treatment).
- Participants who are pregnant or lactating at onset of study.
- Participants who cannot read or speak English.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, 15203
Research Program Coordinator, 412-679-9848, thriving@pitt.edu
Jane M Liebschutz, MD
- Recruiting
UPMC Presbyterian-Montefiore Hospital
Pittsburgh, Pennsylvania, 15213
Research Program Coordinator, 412-679-9848, thriving@pitt.edu
Jane M Liebschutz, MD
- Not yet recruiting
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
Research Program Coordinator, 412-679-9848, thriving@pitt.edu
Jane M Liebschutz, MD
About this study
Official title: Teaching Health Promotion and Resilience in Varied Environments: a Peer-led Intervention Following Hospital Discharge
The purpose of the study is to develop an acceptable, feasible, and effective peer-led bundle of health resilience and promotion services to be delivered in the hospital setting, called the THRIVE intervention.
The main question it aims to answer is: Will participants receiving the THRIVE intervention have a reduced risk of self-reported non-fatal overdoses OR skin/soft tissue infections compared to participants receiving enhanced usual care?
Read more
Researchers will compare the THRIVE model to enhanced usual care to see if the THRIVE model helps participants reduce their number of self-reported non-fatal overdoses OR skin/soft tissue infections.
Intervention participants will:
- Receive one in-person session from a peer support specialist while in the hospital
- Receive weekly text messages from the peer support specialist for a 12-week period
- Receive monthly, multiple-choice assessments via text message at Month 1, 2, 3, 4, 5, and 6
- Complete a baseline, 3-month, and 6-month assessment with Research Assistants
Enhanced usual care participants will:
- Receive a handout with health resilience education and resources in their local area
- Receive monthly, multiple-choice assessments via text message at Month 1, 2, 3, 4, 5, and 6
- Complete a baseline, 3-month, and 6-month assessment with Research Assistants
- Conditions
- Opioid Use Disorder, Harm Reduction, Health Promotion
- Being tested
- Peer Intervention, Enhanced Usual Care
- Keywords
- Opioid Use Disorder, Harm Reduction, Peer Support, Peer Support Specialists
- Medical subject headings
- Opioid-Related Disorders, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer InterventionBehavioural
Participants will receive one peer-led, in-person session boosted by weekly text messages over a 12-week period.
Enhanced Usual CareOther
Participants will receive a handout that includes health resilience education and resources in their local area as part of enhanced usual care.
| Study group | Role | What they receive |
|---|---|---|
| Peer Intervention | Experimental | Not described Receives: Behavioral: Peer Intervention |
| Enhanced Usual Care | Other | Not described Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the THRIVE intervention compared to enhanced usual care (EUC) at lowering the incidence of non-fatal overdoses OR skin and soft tissue infections
Cumulative incidence of non-fatal overdose OR skin and soft tissue infection
Measured: Baseline to 6 months
Secondary outcomes (2)
Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of non-fatal overdoses
Cumulative incidence of non-fatal overdose
Measured: Baseline to 6 months
Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of skin and soft tissue infections
Cumulative incidence of skin and soft tissue infection
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start18 Feb 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Jacqueline D Wilson, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843213
- Sponsor's protocol ID
- 857581
- Other IDs
- 1R01DA057633
- Acronym
- THRIVE
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harm Reduction Principles. National Harm Reduction Coalition. Accessed September 9, 2022. https://harmreduction.org/about-us/principles-of-harm-reduction/
Friedman SR, de Jong W, Rossi D, Touze G, Rockwell R, Des Jarlais DC, Elovich R. Harm reduction theory: users' culture, micro-social indigenous harm reduction, and the self-organization and outside-organizing of users' groups. Int J Drug Policy. 2007 Mar;18(2):107-17. doi: 10.1016/j.drugpo.2006.11.006. Epub 2006 Dec 28.
PubMed 17689353Pauly BB, Reist D, Belle-Isle L, Schactman C. Housing and harm reduction: what is the role of harm reduction in addressing homelessness? Int J Drug Policy. 2013 Jul;24(4):284-90. doi: 10.1016/j.drugpo.2013.03.008. Epub 2013 Apr 25.
PubMed 23623720Pauly B, Wallace B, Barber K. Turning a blind eye: implementation of harm reduction in a transitional programme setting. Drugs Educ Prev Policy. 2018;25(1):21-30. doi:10.1080/09687637.2017.1337081
Pauly B. Harm reduction through a social justice lens. Int J Drug Policy. 2008 Feb;19(1):4-10. doi: 10.1016/j.drugpo.2007.11.005. Epub 2008 Jan 15.
PubMed 18226520Stein MD, Phillips KT, Herman DS, Keosaian J, Stewart C, Anderson BJ, Weinstein Z, Liebschutz J. Skin-cleaning among hospitalized people who inject drugs: a randomized controlled trial. Addiction. 2021 May;116(5):1122-1130. doi: 10.1111/add.15236. Epub 2020 Sep 21.
PubMed 32830383Phillips KT, Stewart C, Anderson BJ, Liebschutz JM, Herman DS, Stein MD. A randomized controlled trial of a brief behavioral intervention to reduce skin and soft tissue infections among people who inject drugs. Drug Alcohol Depend. 2021 Apr 1;221:108646. doi: 10.1016/j.drugalcdep.2021.108646. Epub 2021 Feb 27.
PubMed 33677353Moustaqim-Barrette A, Dhillon D, Ng J, Sundvick K, Ali F, Elton-Marshall T, Leece P, Rittenbach K, Ferguson M, Buxton JA. Take-home naloxone programs for suspected opioid overdose in community settings: a scoping umbrella review. BMC Public Health. 2021 Mar 26;21(1):597. doi: 10.1186/s12889-021-10497-2.
PubMed 33771150McDonald R, Strang J. Are take-home naloxone programmes effective? Systematic review utilizing application of the Bradford Hill criteria. Addiction. 2016 Jul;111(7):1177-87. doi: 10.1111/add.13326. Epub 2016 Mar 30.
PubMed 27028542Krieger MS, Yedinak JL, Buxton JA, Lysyshyn M, Bernstein E, Rich JD, Green TC, Hadland SE, Marshall BDL. High willingness to use rapid fentanyl test strips among young adults who use drugs. Harm Reduct J. 2018 Feb 8;15(1):7. doi: 10.1186/s12954-018-0213-2.
PubMed 29422052Sherman SG, Morales KB, Park JN, McKenzie M, Marshall BDL, Green TC. Acceptability of implementing community-based drug checking services for people who use drugs in three United States cities: Baltimore, Boston and Providence. Int J Drug Policy. 2019 Jun;68:46-53. doi: 10.1016/j.drugpo.2019.03.003. Epub 2019 Apr 13.
PubMed 30991301Goldman JE, Waye KM, Periera KA, Krieger MS, Yedinak JL, Marshall BDL. Perspectives on rapid fentanyl test strips as a harm reduction practice among young adults who use drugs: a qualitative study. Harm Reduct J. 2019 Jan 8;16(1):3. doi: 10.1186/s12954-018-0276-0.
PubMed 30621699Peiper NC, Clarke SD, Vincent LB, Ciccarone D, Kral AH, Zibbell JE. Fentanyl test strips as an opioid overdose prevention strategy: Findings from a syringe services program in the Southeastern United States. Int J Drug Policy. 2019 Jan;63:122-128. doi: 10.1016/j.drugpo.2018.08.007. Epub 2018 Oct 3.
PubMed 30292493Hawk M, Coulter RWS, Egan JE, Fisk S, Reuel Friedman M, Tula M, Kinsky S. Harm reduction principles for healthcare settings. Harm Reduct J. 2017 Oct 24;14(1):70. doi: 10.1186/s12954-017-0196-4.
PubMed 29065896Chan CA, Canver B, McNeil R, Sue KL. Harm Reduction in Health Care Settings. Med Clin North Am. 2022 Jan;106(1):201-217. doi: 10.1016/j.mcna.2021.09.002.
PubMed 34823731
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Health Promotion and Resilience in Varied Environments: a Peer-led Intervention Following Hospital Discharge
- ClinicalTrials.gov ID
- NCT06843213
- Acronym / sponsor ID
- THRIVE / 857581
- Conditions
- Opioid Use Disorder, Harm Reduction, Health Promotion
- Keywords
- Opioid Use Disorder, Harm Reduction, Peer Support, Peer Support Specialists
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Pittsburgh
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 24 Feb 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.
The purpose of the study is to develop an acceptable, feasible, and effective peer-led bundle of health resilience and promotion services to be delivered in the hospital setting, called the THRIVE intervention.
The main question it aims to answer is: Will participants receiving the THRIVE intervention have a reduced risk of self-reported non-fatal overdoses OR skin/soft tissue infections compared to participants receiving enhanced usual care?
Researchers will compare the THRIVE model to enhanced usual care to see if the THRIVE model helps participants reduce their number of self-reported non-fatal overdoses OR skin/soft tissue infections.
Intervention participants will:
- Receive one in-person session from a peer support specialist while in the hospital
- Receive weekly text messages from the peer support specialist for a 12-week period
- Receive monthly, multiple-choice assessments via text message at Month 1, 2, 3, 4, 5, and 6
- Complete a baseline, 3-month, and 6-month assessment with Research Assistants
Enhanced usual care participants will:
- Receive a handout with health resilience education and resources in their local area
- Receive monthly, multiple-choice assessments via text message at Month 1, 2, 3, 4, 5, and 6
- Complete a baseline, 3-month, and 6-month assessment with Research Assistants
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Intervention | Experimental | Behavioral: Peer Intervention |
| Enhanced Usual Care | Other | Other: Enhanced Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who are: a) admitted to University of Pittsburgh Medical Center (UPMC) Shadyside Hospital, UPMC Presbyterian-Montefiore Hospital, UPMC Mercy Hospital for inpatient or observation status, or b) seen in the Emergency Department setting at UPMC Presbyterian-Montefiore Hospital and UPMC Mercy Hospital.
- Participants must have a current diagnosis of Opioid Use Disorder based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria.
- Participants must be at least 18 years of age on day of admission.
- Participants must be able to speak and read English.
Key exclusion criteria (4 listed)
- Participants diagnosed with dementia and/or cognitive impairments.
- Participants with acute psychiatric complications, such as schizophrenia with acute psychosis, acute mania, or suicidal ideation (which may impact the ability of a participant to consent and actively participate in treatment).
- Participants who are pregnant or lactating at onset of study.
- Participants who cannot read or 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 InterventionParticipants will receive one peer-led, in-person session boosted by weekly text messages over a 12-week period. | Behavioural | Peer Intervention |
| Enhanced Usual CareParticipants will receive a handout that includes health resilience education and resources in their local area as part of enhanced usual care. | Other | Enhanced Usual Care |
Primary outcome
Effectiveness of the THRIVE intervention compared to enhanced usual care (EUC) at lowering the incidence of non-fatal overdoses OR skin and soft tissue infections
Time frame: Baseline to 6 months
Cumulative incidence of non-fatal overdose OR skin and soft tissue infection
2 secondary outcomes
Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of non-fatal overdoses
Time frame: Baseline to 6 months
Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of skin and soft tissue infections
Time frame: Baseline to 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 21 Sep 2026.
- BackgroundHarm Reduction Principles. National Harm Reduction Coalition. Accessed September 9, 2022. https://harmreduction.org/about-us/principles-of-harm-reduction/
- Background: PubMed 17689353Friedman SR, de Jong W, Rossi D, Touze G, Rockwell R, Des Jarlais DC, Elovich R. Harm reduction theory: users' culture, micro-social indigenous harm reduction, and the self-organization and outside-organizing of users' groups. Int J Drug Policy. 2007 Mar;18(2):107-17. doi: 10.1016/j.drugpo.2006.11.006. Epub 2006 Dec 28.
- Background: PubMed 23623720Pauly BB, Reist D, Belle-Isle L, Schactman C. Housing and harm reduction: what is the role of harm reduction in addressing homelessness? Int J Drug Policy. 2013 Jul;24(4):284-90. doi: 10.1016/j.drugpo.2013.03.008. Epub 2013 Apr 25.
- BackgroundPauly B, Wallace B, Barber K. Turning a blind eye: implementation of harm reduction in a transitional programme setting. Drugs Educ Prev Policy. 2018;25(1):21-30. doi:10.1080/09687637.2017.1337081
- Background: PubMed 18226520Pauly B. Harm reduction through a social justice lens. Int J Drug Policy. 2008 Feb;19(1):4-10. doi: 10.1016/j.drugpo.2007.11.005. Epub 2008 Jan 15.
- Background: PubMed 32830383Stein MD, Phillips KT, Herman DS, Keosaian J, Stewart C, Anderson BJ, Weinstein Z, Liebschutz J. Skin-cleaning among hospitalized people who inject drugs: a randomized controlled trial. Addiction. 2021 May;116(5):1122-1130. doi: 10.1111/add.15236. Epub 2020 Sep 21.
- Background: PubMed 33677353Phillips KT, Stewart C, Anderson BJ, Liebschutz JM, Herman DS, Stein MD. A randomized controlled trial of a brief behavioral intervention to reduce skin and soft tissue infections among people who inject drugs. Drug Alcohol Depend. 2021 Apr 1;221:108646. doi: 10.1016/j.drugalcdep.2021.108646. Epub 2021 Feb 27.
- Background: PubMed 33771150Moustaqim-Barrette A, Dhillon D, Ng J, Sundvick K, Ali F, Elton-Marshall T, Leece P, Rittenbach K, Ferguson M, Buxton JA. Take-home naloxone programs for suspected opioid overdose in community settings: a scoping umbrella review. BMC Public Health. 2021 Mar 26;21(1):597. doi: 10.1186/s12889-021-10497-2.
- Background: PubMed 27028542McDonald R, Strang J. Are take-home naloxone programmes effective? Systematic review utilizing application of the Bradford Hill criteria. Addiction. 2016 Jul;111(7):1177-87. doi: 10.1111/add.13326. Epub 2016 Mar 30.
- Background: PubMed 29422052Krieger MS, Yedinak JL, Buxton JA, Lysyshyn M, Bernstein E, Rich JD, Green TC, Hadland SE, Marshall BDL. High willingness to use rapid fentanyl test strips among young adults who use drugs. Harm Reduct J. 2018 Feb 8;15(1):7. doi: 10.1186/s12954-018-0213-2.
- Background: PubMed 30991301Sherman SG, Morales KB, Park JN, McKenzie M, Marshall BDL, Green TC. Acceptability of implementing community-based drug checking services for people who use drugs in three United States cities: Baltimore, Boston and Providence. Int J Drug Policy. 2019 Jun;68:46-53. doi: 10.1016/j.drugpo.2019.03.003. Epub 2019 Apr 13.
- Background: PubMed 30621699Goldman JE, Waye KM, Periera KA, Krieger MS, Yedinak JL, Marshall BDL. Perspectives on rapid fentanyl test strips as a harm reduction practice among young adults who use drugs: a qualitative study. Harm Reduct J. 2019 Jan 8;16(1):3. doi: 10.1186/s12954-018-0276-0.
- 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.
Jacqueline D Wilson, MD principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Intervention in people with Opioid Use Disorder and Harm Reduction, run by University of Pennsylvania at 3 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 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 3 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?
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?
Contact Research Program Coordinator (412-679-9848, thriving@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the THRIVE intervention compared to enhanced usual care (EUC) at lowering the incidence of non-fatal overdoses OR skin and soft tissue infections (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06843213, which also lists 47 linked publications.
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 21 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.