Recruiting

Harm Reduction

Sponsor:

University of Pennsylvania

Code:

NCT06843213

Conditions

Opioid Use Disorder

Harm Reduction

Health Promotion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Peer Intervention

Enhanced Usual Care

Study Details

Brief 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.

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

Conditions

Opioid Use Disorder

Harm Reduction

Health Promotion

Study ID

NCT06843213

Start date

Feb 18, 2025

Status verified date

Feb, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

390 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Peer Intervention

other: Enhanced Usual Care

Interventions

Peer Intervention

Participants will receive one peer-led, in-person session boosted by weekly text messages over a 12-week period.

Enhanced Usual Care

Participants will receive a handout that includes health resilience education and resources in their local area as part of enhanced usual care.

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 ]

Central Contacts and Locations

Central contacts

Research Program Coordinator

412-679-9848thriving@pitt.edu

Locations

UPMC Presbyterian-Montefiore Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Research Program Coordinator

412-679-9848thriving@pitt.edu

Principal Investigator:

Jane M Liebschutz, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Opioid Use Disorder
  • Harm Reduction
  • Peer Support
  • Peer Support Specialists

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-02-27.