NavSTAR for Opioid Use Disorder

(Philly NavSTAR Trial)

Overseen By Karen Alexander, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Friends Research Institute, Inc.

Disqualifiers: OUD treatment, Outside Philadelphia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

720 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests NavSTAR, a new approach to improve treatment for people with opioid use disorder (OUD) after hospital discharge. The researchers aim to determine if patient navigators—who offer support and guidance—can increase the number of people who begin and continue OUD treatment compared to usual care. This trial is ideal for individuals diagnosed with moderate to severe OUD who live in Philadelphia and are not currently in a treatment program. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance future treatment options.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the NavSTAR intervention is safe for people with opioid use disorder?

A previous study with 400 participants demonstrated that NavSTAR is safe and effective for individuals with opioid use disorder. The study found that NavSTAR significantly increased the likelihood of starting treatment for opioid use disorder and reduced hospital readmissions. No safety issues were directly linked to the NavSTAR program.

NavSTAR involves collaboration with a trained patient navigator who helps overcome obstacles to care, such as providing encouragement and arranging transportation. The navigator begins assisting patients in the hospital and continues for three months after discharge. This approach supports patients without introducing new medications, reducing the risk of side effects.

Overall, evidence suggests NavSTAR is well-tolerated and does not pose significant safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about NavSTAR because it goes beyond standard treatments like naltrexone, buprenorphine, and methadone by integrating a personal touch with a trained patient navigator. This navigator not only provides motivational support and helps manage withdrawal symptoms but also assists in overcoming practical hurdles, like arranging transportation or obtaining IDs. The continued support from the navigator for three months after hospital discharge aims to improve engagement in treatment and long-term recovery outcomes, offering a more holistic approach to opioid use disorder management.

What evidence suggests that the NavSTAR intervention is effective for opioid use disorder?

Research has shown that NavSTAR, a treatment option in this trial, greatly improves the chances of starting treatment for opioid addiction. In a study with 400 participants, NavSTAR not only helped more individuals begin treatment but also reduced hospital readmissions. Additionally, it proved more affordable than standard treatment. The NavSTAR program includes a patient navigator who assists patients during and after their hospital stay, helping them overcome challenges such as attending appointments or communication issues. These findings suggest NavSTAR could be a promising option for those seeking help with opioid addiction. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals who have been hospitalized and are dealing with opioid use disorder. It aims to help them navigate treatment options post-hospitalization. The study will first involve a small group of 32 patients across four hospitals in Philadelphia, followed by a larger trial with 720 participants.

Inclusion Criteria

I am 18 years old or older.

Current DSM-5 criteria for moderate to severe OUD

I can understand and agree to the study details in English.

Exclusion Criteria

Enrollment in OUD treatment 30 days prior to hospitalization

Residency outside the City of Philadelphia

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Implementation

Pilot NavSTAR with 32 patient participants across 4 hospitals to test feasibility and initial outcomes

3 months

Multiple visits as needed for pilot implementation

Main Trial Implementation

Conduct a large trial with 720 patient participants using a randomized stepped-wedge design to test NavSTAR's effectiveness and sustainability

30 months

Ongoing visits for training, resources, and performance feedback

Follow-up

Participants are monitored for outcomes such as OAT initiation, hospital readmissions, and quality of life improvements

12 months

Follow-up assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• NavSTAR

Trial Overview The NavSTAR intervention, which has previously shown promise in increasing treatment entry and reducing hospital readmissions for opioid use disorder, is being tested for its effectiveness when implemented across multiple hospitals within a health system.

How Is the Trial Designed?

Group I: NavSTAR Experimental Treatment 1 Intervention

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

Group II: Treatment as Usual Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Friends Research Institute, Inc.

Lead Sponsor

Trials

60

Recruited

22,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Thomas Jefferson University

Collaborator

Trials

475

Recruited

189,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07262190?term=NA

NavSTAR Implementation Effectiveness Trial Across a ... The research team showed in a previous study with 400 participants that NavSTAR significantly increased entry into opioid use disorder treatment ...

2. reporter.nih.gov reporter.nih.gov/project-details/11360494

Project Details Our research team showed in a single-site randomized trial with 400 participants that NavSTAR significantly improved OAT entry, reduced readmissions, and was ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837321

Addiction Consult Services, Mortality, and Acute Care ... Previous studies suggest that addiction consult services are associated with lower acute care utilization and mortality after hospitalization ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06634277/philly-navstar-implementation-trial

Philly NavSTAR Implementation Trial | Clinical Research ... Our research team showed in a previous study with 400 participants that NavSTAR significantly increased entry into opioid use disorder treatment ...

5. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-024-00463-9

a secondary analysis of predictors from the NavSTAR Trial Study findings showed that, on an intention-to-treat basis, NavSTAR participants had significantly lower subsequent hospital service utilization ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07262190?locStr=United+States&country=United+States&aggFilters=status%3A

NavSTAR Implementation Effectiveness Trial Across a ... The research team showed in a previous study with 400 participants that NavSTAR significantly increased entry into opioid use disorder treatment ...

7. withpower.com withpower.com/trial/navstar-intervention-for-opioid-use-disorder-8d171

NavSTAR Intervention for Opioid Use Disorder (Philly ... While naltrexone effectively reduces the rewarding effects of opioids to prevent relapse, there are safety concerns, including potential liver damage at high ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10728463/

Polysubstance use and post-discharge mortality risk among ... Highlights. •. There is a high risk of post-discharge mortality among hospitalized patients with opioid use disorder.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2772724622000099

Opioid agonist treatment initiation and linkage for ... Moreover, patients with OUD are at increased risk of death from drug-related causes, including but not limited to overdose, following discharge (King et al., ...

10. researchgate.net researchgate.net/publication/397349253_Outcomes_of_a_Hospitalist-Led_Consult_Service_for_Patients_with_Opioid_Use_Disorder_A_Propensity_Score_Weighted_Study

Outcomes of a Hospitalist-Led Consult Service for Patients ... Outcomes of a Hospitalist-Led Consult Service for Patients with Opioid Use Disorder: A Propensity Score Weighted Study.