NavSTAR Intervention for Opioid Use Disorder

(Philly NavSTAR Trial)

Recruiting at 1 trial location

Overseen By Jan Gryczynski, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Friends Research Institute, Inc.

Disqualifiers: Pregnancy, Long-term care, Suicide attempt, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

32 Participants Needed

Trial Summary

What is the purpose of this trial?

Patient Navigation (PN) interventions following hospitalization can reduce the differences that certain groups have been trying to access opioid use disorder treatment. These differences, which affect racial minority groups the most, contribute to the opioid overdose epidemic. However, 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. Our 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, we will conduct a large trial with 720 patient participants to see if we can reach people who need the intervention, and create a sustainable plan to continue the intervention after the grant award period.

Will I have to stop taking my current medications?

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 data supports the effectiveness of the NavSTAR treatment for opioid use disorder?

The research highlights the effectiveness of medications for opioid use disorder (OUD) like naltrexone and buprenorphine, which are part of the gold standard treatment. Additionally, behavioral support, such as computer-assisted therapy, has shown to reduce opioid use and improve overall functioning, suggesting that multi-component interventions like NavSTAR could be beneficial. ^{1 2 3 4 5}

Is the NavSTAR Intervention for Opioid Use Disorder safe for humans?

Naltrexone, a key component of the NavSTAR intervention, is generally considered safe for humans. Side effects are usually mild, such as nausea and abdominal pain, and occur in a minority of patients. Sustained release forms of naltrexone have been shown to have acceptable safety profiles and may reduce the risk of opioid overdose. ^{6 7 8 9 10}

What makes the NavSTAR treatment unique for opioid use disorder?

The NavSTAR treatment is unique because it incorporates patient navigation, which includes personalized support like strengths-based case management and motivational interviewing, to help individuals with opioid use disorder engage in and maintain necessary medical and psychosocial care, unlike traditional medication-focused treatments. ^{11 12 13 14 15}

Research Team

Karen Alexander, PhD

Principal Investigator

Friends Research Institute, Inc.

Jan Gryczynski, MD

Principal Investigator

Friends Research Institute, Inc.

Eligibility Criteria

This trial is for individuals who have been hospitalized and are dealing with opioid use disorder. It aims to help those, especially from racial minority groups, access treatment post-hospitalization. The study will first involve a small group across four hospitals in Philadelphia before expanding.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Testing

Conducting four short-duration, iterative pilot testing cycles in four hospitals to examine the Implementation Facilitation strategy for feasibility and acceptability

4 months

Multiple visits across 4 hospitals

Implementation

Large trial with 720 patient participants to implement NavSTAR and create a sustainable plan for post-discharge opioid agonist treatment

10 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including opioid agonist treatment initiation and other secondary outcomes

3 months

Treatment Details

Interventions

• NavSTAR (Philly adaptation)

Trial Overview The NavSTAR (Philly adaptation) intervention is being tested to see if it can improve entry into opioid use disorder treatment, reduce hospital readmissions, and be cost-effective. The trial involves engaging community and hospital partners to implement this patient navigation system.

Participant Groups

Group I: NavSTAR Experimental Treatment 1 Intervention

NavSTAR is a Patient Navigation service model to reduce internal and external barriers to recommended service engagement. It includes motivational interventions in tandem with proactive barrier resolution, targeting areas of addiction, medical, self-care, and basic needs.

NavSTAR (Philly adaptation) is already approved in United States for the following indications:

Approved in United States as NavSTAR for:

• Opioid use disorder treatment

Who Is Running the Clinical Trial?

Friends Research Institute, Inc.

Lead Sponsor

Trials

60

Recruited

22,500+

Thomas Jefferson University

Collaborator

Trials

475

Recruited

189,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

The youth opioid recovery support (YORS) intervention significantly improved adherence to extended-release naltrexone (XR-NTX), with participants receiving an average of 4.28 doses compared to only 0.70 doses in the standard treatment group over 24 weeks.

Participants in the YORS group had a much lower relapse rate (61%) compared to the treatment as usual group (95%), indicating that YORS not only enhanced medication adherence but also effectively reduced the likelihood of returning to opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder. Fishman, M., Wenzel, K., Vo, H., et al.[2021]

In a study of 535 individuals with opioid use disorders over 24 weeks, distinct patterns of opioid use were identified for those treated with buprenorphine-naloxone (BUP-NX) and extended-release naltrexone (XR-NTX), highlighting the complexity of treatment responses.

Patients in the 'near abstinent/no use' category had the most medical management visits, suggesting that higher engagement in treatment correlates with better outcomes, while previous successful treatment history was more common in the low use group for BUP-NX.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trajectory classes of opioid use among individuals in a randomized controlled trial comparing extended-release naltrexone and buprenorphine-naloxone. Ruglass, LM., Scodes, J., Pavlicova, M., et al.[2020]

Medication treatment for opioid use disorder (MOUD) is highly effective in reducing illicit opioid use and associated harms, yet only about one-third of Veterans diagnosed with OUD received MOUD by 2017.

The VHA's SCOUTT Initiative aims to improve access to MOUD by training healthcare providers in non-specialty settings, potentially serving as a model for implementing MOUD in large healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative: Expanding access to medication treatment for opioid use disorder within Veterans Health Administration facilities. Gordon, AJ., Drexler, K., Hawkins, EJ., et al.[2021]

A performance improvement project involving 47 opioid-dependent inpatients and their families showed that overdose prevention training significantly increased their ability to recognize an opioid overdose and their comfort in assisting during an overdose situation.

Despite 32% of family members being aware of a prior overdose, the training highlighted the importance of naloxone education and harm reduction strategies, suggesting that such programs are beneficial and should be integrated into residential treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid overdose prevention in a residential care setting: Naloxone education and distribution. Pade, P., Fehling, P., Collins, S., et al.[2018]

A study involving 1,107 individuals with opioid use disorder showed that engaging with the computer-assisted therapy program 'Breaking Free Online' led to significant reductions in opioid use and improvements in biopsychosocial functioning, with effect sizes ranging from 0.15 to 0.50.

Participants with greater baseline clinical impairment experienced more substantial improvements post-treatment, suggesting that CAT could be particularly beneficial for those with more complex psychosocial issues when combined with medications for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between baseline opioid use disorder severity, mental health and biopsychosocial functioning, with clinical responses to computer-assisted therapy treatment. Elison-Davies, S., Märtens, K., Yau, C., et al.[2021]

Naltrexone is a safe and effective treatment option for heroin dependence, particularly for highly motivated individuals who are already opiate-free.

While naltrexone has minimal side effects, primarily gastrointestinal issues, patient compliance remains a challenge due to the lack of immediate consequences for discontinuing the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of heroin-dependent persons with antagonists: current status. Renault, PF.[2013]

The FDA-approved extended-release formulation of naltrexone, administered as a monthly injection, may improve adherence and retention rates in treating opioid dependence compared to the oral form, which has low compliance (less than 30%).

While naltrexone effectively reduces the rewarding effects of opioids to prevent relapse, there are safety concerns, including potential liver damage at high doses and risks of opioid overdose if individuals attempt to overcome the drug's antagonistic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone extended-release injection: an option for the management of opioid abuse. Taylor, R., Raffa, RB., Pergolizzi, JV.[2021]

Sustained release naltrexone (SRX) formulations, which can release the opioid antagonist for 1-7 months, have been shown to effectively reduce heroin use and have an acceptable safety profile based on multiple studies.

SRX not only helps in reducing opioid use but also appears to positively impact other areas such as reducing risky behaviors associated with blood-borne diseases, although more controlled studies are needed to fully understand its effectiveness compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injectable and implantable sustained release naltrexone in the treatment of opioid addiction. Kunøe, N., Lobmaier, P., Ngo, H., et al.[2021]

The sustained release naltrexone implant significantly reduced opioid overdoses in a cohort of 361 heroin-dependent individuals, with no overdoses reported in the 6 months following treatment, compared to 21 overdoses in the 6 months prior.

While the implant effectively prevented opioid overdoses, there was an increase in sedative overdoses shortly after treatment, highlighting the need for comprehensive management of poly-substance use among heroin users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing hospital presentations for opioid overdose in patients treated with sustained release naltrexone implants. Hulse, GK., Tait, RJ., Comer, SD., et al.[2018]

Veterans receiving buprenorphine for opioid use disorder had a significantly lower risk of death by suicide or overdose, being 4.33 times less likely to die compared to those not on the medication, based on a study of Veterans from 2008 to 2017.

The risk of suicide or overdose was particularly high shortly after discontinuing buprenorphine treatment, indicating that ongoing pharmacotherapy is crucial for reducing mortality risks in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Buprenorphine for Opioid Use Disorder and Mortality Risk. Vakkalanka, P., Lund, BC., Arndt, S., et al.[2022]

Long-term opioid agonist therapy with methadone and buprenorphine has been shown to be highly effective in treating opioid use disorder (OUD), significantly reducing the risk of relapse and saving lives.

Despite the effectiveness of these treatments, the delivery of prevention and treatment for OUD is often hindered by coexisting health issues, lack of support, and varying public opinions, highlighting the need for better scientific communication and evidence-based strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid use disorder. Strang, J., Volkow, ND., Degenhardt, L., et al.[2021]

The opioid crisis has significantly impacted pregnant women, with a fourfold increase in opioid use disorder (OUD) diagnoses over the past decade, highlighting the urgent need for targeted interventions.

The OPTI-Mom 2.0 study aims to evaluate a patient navigation (PN) intervention designed to improve care engagement and treatment retention for pregnant women with OUD, potentially reducing adverse outcomes for both mothers and their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot multisite study of patient navigation for pregnant women with opioid use disorder. Cochran, G., Smid, MC., Krans, EE., et al.[2021]

A quality improvement initiative successfully implemented a program to initiate buprenorphine/naloxone treatment for opioid use disorder in 107 emergency departments across Alberta, leading to increased treatment initiation rates.

Most patients (67%) continued their opioid agonist prescriptions 180 days after their emergency department visit, and safety events were minimal, indicating that the program is both effective and safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine/naloxone initiation and referral as a quality improvement intervention for patients who live with opioid use disorder: quantitative evaluation of provincial spread to 107 rural and urban Alberta emergency departments. Stone, KD., Scott, K., Holroyd, BR., et al.[2023]

In a study of 570 participants receiving medication for opioid use disorder, any attendance at counseling or 12-Step programs was linked to lower odds of opioid use, highlighting the importance of psychosocial support in treatment.

Specifically, each additional hour of 12-Step attendance reduced the odds of opioid use by 13%, and the effectiveness of group counseling varied by treatment type, suggesting that the timing and type of psychosocial support can significantly influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-lagged association between counseling and/or 12-Step attendance with subsequent opioid use in a secondary analysis from a randomized, clinical trial of medications for opioid use disorder. Hefner, K., Choo, TH., Shmueli-Blumberg, D., et al.[2023]

Since 1996, community-based programs have trained over 53,000 individuals and distributed naloxone, leading to 10,171 reported reversals of opioid overdoses, highlighting the efficacy of naloxone in preventing fatal outcomes from opioid overdoses.

Naloxone is specifically effective for reversing opioid overdoses, but it does not work on non-opioid overdoses, emphasizing the need for targeted education and distribution of naloxone among those at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based opioid overdose prevention programs providing naloxone - United States, 2010. [2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Trajectory classes of opioid use among individuals in a randomized controlled trial comparing extended-release naltrexone and buprenorphine-naloxone. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative: Expanding access to medication treatment for opioid use disorder within Veterans Health Administration facilities. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Opioid overdose prevention in a residential care setting: Naloxone education and distribution. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Associations between baseline opioid use disorder severity, mental health and biopsychosocial functioning, with clinical responses to computer-assisted therapy treatment. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Treatment of heroin-dependent persons with antagonists: current status. [2013]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Naltrexone extended-release injection: an option for the management of opioid abuse. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Injectable and implantable sustained release naltrexone in the treatment of opioid addiction. [2021]

9. Ireland pubmed.ncbi.nlm.nih.gov

Reducing hospital presentations for opioid overdose in patients treated with sustained release naltrexone implants. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Association Between Buprenorphine for Opioid Use Disorder and Mortality Risk. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Opioid use disorder. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

A pilot multisite study of patient navigation for pregnant women with opioid use disorder. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Buprenorphine/naloxone initiation and referral as a quality improvement intervention for patients who live with opioid use disorder: quantitative evaluation of provincial spread to 107 rural and urban Alberta emergency departments. [2023]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Time-lagged association between counseling and/or 12-Step attendance with subsequent opioid use in a secondary analysis from a randomized, clinical trial of medications for opioid use disorder. [2023]

15. United States pubmed.ncbi.nlm.nih.gov

Community-based opioid overdose prevention programs providing naloxone - United States, 2010. [2022]