Recruiting

NavSTAR

Sponsor:

Friends Research Institute, Inc.

Code:

NCT07262190

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NavSTAR (Philly adaptation)

Study Details

Brief summary:

Patient Navigation (PN) interventions following hospitalization can improve outcomes for people with opioid use disorder treatment. Delivering PN interventions on a wide scale requires many resources and coordination across institutions. This will use an evidence-based process to find solutions to these significant barriers by engaging community, hospital, and patient partners. This study is being conducted to learn more about how to implement NavSTAR, a patient navigation intervention for people with opioid use disorder, across a health system. The research team showed in a previous study with 400 participants that NavSTAR significantly increased entry into opioid use disorder treatment, reduced readmissions to the hospital, and was highly cost- effective compared to treatment as usual. This study will first pilot NavSTAR with 32 patient participants across 4 hospitals in the City of Philadelphia. Then, a large trial with 720 patient participants will be conducted to see if people who need the intervention are reached, and a sustainable plan will be created to continue the intervention after the grant award period.

Conditions

Opioid Use Disorder

Study ID

NCT07262190

Start date

Oct 27, 2025

Status verified date

Sep, 2025

Completion date

Aug 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. age 18 or older;
2. current DSM-5 criteria for moderate to severe OUD;
3. willing and able to provide informed consent in English.

Exclusion Criteria:

1. enrollment in OUD treatment 30-days prior to hospitalization;
2. residency outside the City of Philadelphia;
3. pregnancy;
4. planned discharge to a long-term inpatient care facility (e.g., hospice);
5. hospitalization for a suicide attempt.

Study Design

Enrollment

720 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Treatment as Usual

Treatment as usual consists of standard management by the medical or surgical team during inpatient admission, and usual care from the addiction consult service, if applicable, which provides social work consults, withdrawal symptom management, and initiation of naltrexone, buprenorphine, or methadone. All standard hospital services will be available to participants.

experimental: NavSTAR

NavSTAR consists of TAU plus contact with a trained patient navigator who delivers the NavSTAR intervention, inclusive of theory-based motivational content, during and after discharge from the hospital. The patient navigator also has access to a small participant fund to assist with overcoming structural barriers to care (e.g., phone, obtaining IDs, a meal, a taxi ride etc.). Using the NavSTAR PN manual, the PN will address internal and external barriers to engagement in OAT through motivational intervention techniques and proactive case management and care coordination services. Contact with the PN begins at the bedside while the participant is admitted to the hospital and continues for 3 months after discharge

Interventions

NavSTAR (Philly adaptation)

NavSTAR consists of TAU plus contact with a trained patient navigator who delivers the NavSTAR intervention, inclusive of theory-based motivational content, during and after discharge from the hospital. The patient navigator also has access to a small participant fund to assist with overcoming structural barriers to care (e.g., phone, obtaining IDs, a meal, a taxi ride etc.). Using the NavSTAR PN manual, the PN will address internal and external barriers to engagement in OAT through motivational intervention techniques and proactive case management and care coordination services. Contact with the PN begins at the bedside while the participant is admitted to the hospital and continues for 3 months after discharge

Primary outcome measure

  • Rate of Opioid Agonist Treatment initiation [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Karen Alexander, PhD

2673983560kalexander@friendsresearch.org

Jan Gryczynski, PhD

443-676-4219jgryczynski@friendsresearch.org

Locations

Jefferson Health

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Karen Alexander, PhD

267-398-3560kalexander@friendsresearch.org

More Information

Sponsor

Friends Research Institute, Inc.

Last update posted

Dec 3, 2025

Last verified

Sep, 2025

Keywords

  • patient navigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Friends Research Institute, Inc. on 2025-12-03.