Buprenorphine + Patient Navigation for Opioid Use Disorder

(OUTLAST-B Trial)

Enrolling by invitation at 1 trial location

Overseen By Courtney Nordeck, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Friends Research Institute, Inc.

Must not be taking: Methadone, Naltrexone, Benzodiazepines, others

Disqualifiers: Pregnancy, Psychosis, Suicidal ideation, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks the best method to connect individuals with opioid use disorder (OUD) to treatment through sexual health clinics. It compares three approaches: usual care, support from a patient navigator to guide treatment choices, and a combination of navigation support with initiating buprenorphine (a medication that reduces cravings and withdrawal symptoms). Individuals who have used opioids in the last 30 days and meet the criteria for OUD with physical dependence might be suitable candidates, particularly if they are open to trying buprenorphine. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently on buprenorphine, methadone, or extended-release naltrexone for opioid use disorder, you cannot participate in this study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that taking more than 16 mg of buprenorphine is safe and well tolerated for people with opioid use disorder. When taken as directed, buprenorphine is unlikely to cause serious side effects. It effectively reduces withdrawal symptoms and cravings.

Research has also shown that buprenorphine can be used safely for more than six months, allowing for extended use.

Studies have demonstrated that helping patients connect to necessary care can reduce hospital visits. This support is safe and carries no known risks.

These findings suggest that both buprenorphine and patient support are safe options for those considering this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for opioid use disorder because they combine buprenorphine with innovative support strategies. Buprenorphine is a well-known medication that helps reduce withdrawal symptoms and cravings, but the addition of a Patient Navigator is what sets these treatments apart. This role involves guiding patients through the treatment process, helping them find the right community program, and ensuring they stick with their treatment plan. Moreover, the experimental arm introduces buprenorphine initiation right at the clinic, offering immediate support and a bridge to further community-based care. This approach aims to improve access and retention in opioid use disorder treatment, potentially leading to better outcomes for individuals struggling with addiction.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Studies have shown that buprenorphine effectively treats opioid use disorder (OUD), reducing the risk of overdose and other serious health issues related to opioids. In this trial, some participants will receive buprenorphine along with patient navigation services. Research indicates that higher doses of buprenorphine can lead to better treatment outcomes. Evidence suggests that patient navigation, which guides patients through their treatment, increases attendance in OUD care and improves outcomes by helping patients access and remain in treatment. Together, these treatments aim to enhance OUD management through medication and support. ^{1 2 3 6 7}

Who Is on the Research Team?

Jan Gryczynski, MD

Principal Investigator

Friends Research Institute, Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with opioid use disorder who have used opioids in the last month and are willing to try buprenorphine treatment. It's not for those misusing benzodiazepines, pregnant women, people with unstable health conditions or heavy alcohol users, anyone already in OUD treatment, or unable to consent.

Inclusion Criteria

DSM-5 diagnostic criteria for OUD with physiological dependence

Opioid use in the past 30 days

I am willing to try buprenorphine treatment.

Exclusion Criteria

Heavy alcohol use that, in the judgement of the prescribing provider, raises a safety concern that precludes eligibility for buprenorphine induction

I do not have any unstable medical or mental health conditions.

Pregnancy (due to special needs; will be treated outside of the study)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to one of three arms: Usual Care, Patient Navigation, or Patient Navigation + Buprenorphine Initiation. Treatment includes standard services, patient navigation, and/or buprenorphine initiation.

6 months

Regular visits as per arm assignment

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, 3 months, and 6 months.

6 months

3 visits (in-person or virtual)

Long-term follow-up

Selected outcomes will be examined through 12 months via health record linkage methods.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Buprenorphine
• Patient Navigation

Trial Overview The study compares three strategies at sexual health clinics: usual care; patient navigation (PN); and PN plus immediate start of buprenorphine (PN+BUP). The goal is to see which method best helps patients link to opioid use disorder treatments.

How Is the Trial Designed?

Group I: Patient Navigation + Buprenorphine Initiation (PN+BUP) Experimental Treatment 2 Interventions

The PN+BUP Arm will include all PN Arm services, with the addition of meeting with the sexual health clinic's buprenorphine-waivered provider (typically a nurse practitioner) to initiate buprenorphine treatment, as a bridge until successful transfer to OUD treatment in the community. The standard buprenorphine bridge prescription will be for buprenorphine/naloxone film: 8/2mg, up to 16mg per day, 7 day supply.

Group II: Patient Navigation (PN) Active Control 1 Intervention

The PN Arm will include all UC Arm services, with the addition of a Patient Navigator who will assist the participant in selecting a community OUD treatment program, facilitate an intake appointment, help to resolve barriers and coordinate OUD treatment entry, and support early retention in OUD treatment.

Group III: Usual Care (UC) Active Control 1 Intervention

The UC Arm will include standard services from the sexual health clinic / city health department \[at the time of the study, no standardized intervention for opioid use disorder treatment linkage\].

Buprenorphine is already approved in United States, European Union for the following indications:

Approved in United States as Buprenorphine for:

• Moderate to severe opioid addiction (dependence)

Approved in European Union as Buprenorphine for:

• Opioid dependence

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+

Baltimore City Health Department

Collaborator

Trials

9

Recruited

19,200+

Published Research Related to This Trial

The study will involve 280 adults with opioid use disorder and aims to improve adherence to buprenorphine-naloxone treatment through two psychological interventions: contingency management (CM) and brief motivational interviewing plus substance-free activities and mindfulness (BSM).

The primary goal is to assess which intervention is more effective in promoting medication adherence, measured by attendance at physician appointments and the presence of buprenorphine in urine toxicology, with follow-up occurring 8 months after randomization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a sequential multiple assignment randomized trial to test contingency management and an integrated behavioral economic and mindfulness intervention for buprenorphine-naloxone medication adherence for opioid use disorder. Peter, SC., Murphy, JG., Witkiewitz, K., et al.[2023]

After three years of buprenorphine's approval for office-based treatment of opioid addiction, nearly 90% of addiction specialists were authorized to prescribe it, with two-thirds actively treating patients, indicating strong adoption among specialists.

In contrast, fewer than 10% of non-addiction specialist psychiatrists prescribed buprenorphine, highlighting a significant gap in treatment access and suggesting that organizational support and training are crucial for expanding its use beyond addiction specialists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of buprenorphine for addiction treatment: perspectives of addiction specialists and general psychiatrists. Thomas, CP., Reif, S., Haq, S., et al.[2021]

In a study involving 546 buprenorphine prescribers across six U.S. jurisdictions, only 54% of Medicaid patients and 62% of uninsured patients were offered new appointments for buprenorphine treatment, indicating significant barriers to access for those seeking help for opioid use disorder.

Despite these barriers, the median wait times for appointments were relatively short, at around 6 days for Medicaid patients and 5 days for uninsured patients, suggesting that there is potential to improve access to treatment by better utilizing the existing prescriber workforce.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Access to Office-Based Buprenorphine Treatment in Areas With High Rates of Opioid-Related Mortality: An Audit Study. Beetham, T., Saloner, B., Wakeman, SE., et al.[2021]

Buprenorphine, particularly the brand-name formulations like Suboxone, has been significantly more utilized and reimbursed in Medicaid compared to other formulations, with brand-name versions dispensed 2.7 times more and costing 4.4 times more than all other formulations combined from 2002 to 2018.

Delays in the availability of generic buprenorphine formulations due to market and regulatory factors contributed to increased costs and may have hindered access to treatment for opioid use disorder during the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Affecting Buprenorphine Utilization and Spending in Medicaid, 2002-2018. Barenie, RE., Sinha, MS., Kesselheim, AS.[2021]

Buprenorphine, approved for treating opiate dependence, has been found to have an abuse potential similar to that of traditional opioids like morphine, despite initial beliefs of its low abuse risk.

A study of 120 buprenorphine abusers revealed that the majority were middle-aged males with a significant history of early illicit drug use, highlighting a concerning trend of prescription medication abuse that requires increased awareness and vigilance among healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Socio-demographic profile and help-seeking behaviour of buprenorphine abusers in Singapore. Winslow, M., Ng, WL., Mythily, S., et al.[2020]

In a study of 533 participants over 18 months after stopping extended-release buprenorphine injection (BUP-XR), 47% reported sustained opioid abstinence, with higher rates of abstinence linked to longer treatment durations.

More than 60% of participants showed stable or improved outcomes in health-related quality of life and mental health scores, indicating that BUP-XR has a long-term positive impact on recovery from opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continued Posttrial Benefits of Buprenorphine Extended Release: RECOVER Study Findings. Boyett, B., Nadipelli, VR., Solem, CT., et al.[2023]

A study involving 53 opioid-dependent patients showed that switching from buprenorphine to buprenorphine/naloxone was well-tolerated, with no significant issues reported during the transition.

Patients expressed a preference for buprenorphine/naloxone over buprenorphine, with 54% favoring the combination formulation due to its taste and ease of use, indicating it may be a more acceptable option for maintenance treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preference for buprenorphine/naloxone and buprenorphine among patients receiving buprenorphine maintenance therapy in France: a prospective, multicenter study. Daulouède, JP., Caer, Y., Galland, P., et al.[2015]

Buprenorphine (Subutex) is recognized for its improved safety profile in treating opioid dependence, particularly by reducing the risk of overdose compared to other opioids.

Despite its safety advantages, there are still risks associated with the diversion of buprenorphine for misuse, as evidenced by cases of attempted intravenous injection, highlighting the need for strict dispensing protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Groin tissue necrosis requiring skin graft following parenteral abuse of buprenorphine tablets. Feeney, GF., Fairweather, P.[2013]

The novel weekly subcutaneous buprenorphine depot formulation, CAM2038, was found to effectively block the euphoric effects of opioids and suppress withdrawal symptoms in individuals with moderate-to-severe opioid use disorder, based on a study involving 47 participants.

Both doses of CAM2038 (24 mg and 32 mg) were well-tolerated and demonstrated significant efficacy in preventing opioid effects, making it a promising alternative to daily oral formulations that carry risks of misuse and nonadherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial. Walsh, SL., Comer, SD., Lofwall, MR., et al.[2020]

New prolonged-release formulations of buprenorphine, including a six-month implant and two subcutaneous injection depots, aim to improve patient comfort and safety by reducing the need for daily intake and minimizing risks associated with sublingual forms.

These formulations have shown promise in addressing concerns about treatment adherence, particularly for stabilized patients, while also raising some apprehensions about potential coercive use among opioid users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prolonged-release buprenorphine formulations: Perspectives for clinical practice]. Chappuy, M., Trojak, B., Nubukpo, P., et al.[2022]

Citations

1. nih.gov nih.gov/news-events/news-releases/higher-doses-buprenorphine-may-improve-treatment-outcomes-people-opioid-use-disorder

Higher doses of buprenorphine may improve treatment ... These findings suggest that higher buprenorphine doses could be more effective in managing opioid use disorder, which may be particularly relevant for ...

2. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates Medications for opioid use disorder (OUD), particularly buprenorphine and methadone, substantially reduce overdose-related and overall mortality ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2760032

Comparative Effectiveness of Different Treatment Pathways ... Treatment with buprenorphine or methadone was associated with reductions in overdose and serious opioid-related acute care use compared with other treatments.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949875923002060

Integrated analysis of phase 3 studies Extending BUP-XR treatment beyond 6 months sustained improvement in opioid abstinence and was well tolerated, supporting clinical benefit up to 18 months.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6585403/

Buprenorphine Treatment for Opioid Use Disorder The rate of relapse by the end of 24 weeks was 57% on buprenorphine versus 65% on injection naltrexone. Most of this difference could be accounted for by the ...

6. samhsa.gov samhsa.gov/substance-use/treatment/options/buprenorphine

What is Buprenorphine? Side Effects, Treatment & Use When taken as prescribed, buprenorphine is safe and effective. Buprenorphine has unique pharmacological properties that: Diminish the effects of ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.16600

Dose‐specific clinical outcomes in patients with opioid use ... These data indicate that higher dosing of buprenorphine can confer a physiological benefit which, in turn, may improve outcomes and reduce harm ...