Buprenorphine Formulations for Opioid Use Disorder in Jail

Recruiting at 3 trial locations

Overseen By David Farabee

Age: Any Age

Sex: Male

Trial Phase: Phase 4

Sponsor: NYU Langone Health

Must be taking: Sublingual buprenorphine

Must not be taking: Opioid pain medications

Disqualifiers: Sentenced, Allergy, Chronic pain, 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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to treat opioid use disorder among people in jail. It compares a new, long-acting medication (extended-release buprenorphine, or XRB) with the standard daily treatment (sublingual buprenorphine, or SLB). Researchers aim to determine which method better supports continued treatment after release and reduces medication-related rule-breaking. The trial seeks men who are currently jailed, unsentenced, and have used sublingual buprenorphine for at least three days before entering jail. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it involves switching from sublingual buprenorphine (SLB) to extended-release buprenorphine (XRB) for some participants. If you are on SLB, you may continue it or be switched to XRB.

What is the safety track record for these treatments?

Research has shown that extended-release buprenorphine (XRB) is generally safe for treating opioid use disorder. One study found it safe even for individuals at high risk of overdose, although some experienced difficulty continuing the treatment over time. The FDA has approved XRB for managing moderate to severe opioid use disorder, indicating a strong safety record.

For sublingual buprenorphine (SLB), studies confirm its safety and effectiveness when used as directed. It helps reduce cravings and withdrawal symptoms. Safety data from over 500 people using SLB show it is well-tolerated, with few side effects reported.

Both XRB and SLB treat opioid use disorder and are considered safe options with well-known safety profiles. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because extended-release buprenorphine (XRB) offers a new way to tackle opioid use disorder, especially in jail settings. Unlike traditional sublingual buprenorphine (SLB), which needs to be taken daily under supervision, XRB is administered as a monthly injection. This not only helps ensure consistent treatment but also reduces the risk of noncompliance and misuse, which are common challenges with daily medications. By maintaining steady medication levels in the body, XRB could potentially improve treatment outcomes and make managing opioid use disorder in jails more effective and convenient.

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

This trial will compare two treatments for opioid use disorder in jail: extended-release buprenorphine (XRB) and sublingual buprenorphine (SLB). Research has shown that XRB effectively treats opioid use disorder, helping individuals stay off opioids longer and reducing cravings more than other treatments. One study found that people using XRB remained opioid-free for 95 days, compared to 77 days with other treatments. SLB is also effective, aiding many in adhering to their treatment and managing their opioid use disorder. However, some research suggests that XRB might surpass SLB in patient satisfaction and long-term treatment retention. Both treatments have proven effective for opioid use disorder. Participants in this trial will be randomized to either transition to XRB or remain on SLB. ^{2 3 6 7 8}

Who Is on the Research Team?

David Farabee, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for unsentenced men entering Middlesex County House of Corrections with an existing prescription for Sublingual Buprenorphine (SLB), having taken it for at least 3 days, and willing to be randomly assigned to a new treatment. They must understand English, agree to the study's terms, and expect to stay in jail for at least 4 days. Those with chronic pain needing opioids or allergies to the medications cannot join.

Inclusion Criteria

You are expected to stay in jail for a minimum of four days.

You are willing to be randomly assigned the opportunity of transitioning to XRB whilst in custody.

Unsentenced

Exclusion Criteria

Sentenced

I need opioids or similar medications to manage my chronic pain.

I am allergic or have a bad reaction to certain medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either transition to extended-release buprenorphine (XRB) or remain on sublingual buprenorphine (SLB) while in jail

Up to 6 months

Follow-up

Participants are monitored for continuation of MOUD treatment in the community and infractions related to buprenorphine diversion

Up to 9 months

What Are the Treatments Tested in This Trial?

Interventions

• Extended-Release Buprenorphine (XRB)
• Sublingual Buprenorphine (SLB)

Trial Overview The study compares two treatments for opioid addiction in jailed individuals: one group will switch from SLB to Extended-Release Buprenorphine (XRB) upon admission, while the other remains on SLB. The goal is to see which method is better at ensuring participants have medication when released, continue treatment outside jail, and reduce drug-related infractions.

How Is the Trial Designed?

Group I: Transition to Extended-Release Buprenorphine (XRB) Experimental Treatment 1 Intervention

Participants randomized to transition to treatment with XRB.

Group II: Sublingual Buprenorphine (SLB) Maintenance Active Control 1 Intervention

Participants randomized to remain on-treatment with SLB.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a study of 78 patients over six years at the High-Risk Pain Clinic, buprenorphine/naloxone was found to significantly reduce pain scores, indicating its efficacy in managing chronic pain for patients with a history of substance use disorder.

The clinic had a retention rate of 41%, suggesting that while many patients continued treatment, there is still a notable number who may not stay engaged in this multimodal approach to pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sublingual Buprenorphine/Naloxone and Multi-Modal Management for High-Risk Chronic Pain Patients. Kaski, S., Marshalek, P., Herschler, J., et al.[2021]

In a clinical trial with 428 participants, weekly and monthly subcutaneous (SC) buprenorphine depot formulations were found to be noninferior to daily sublingual (SL) buprenorphine with naloxone in treating opioid use disorder, showing similar response rates and urine test results for opioid use.

The SC buprenorphine group demonstrated a statistically superior cumulative distribution function (CDF) for no illicit opioid use compared to the SL buprenorphine group, suggesting that depot formulations may offer additional benefits in treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial. Lofwall, MR., Walsh, SL., Nunes, EV., et al.[2022]

The new sublingual buprenorphine/naloxone tablet (Zubsolv®) has higher bioavailability and better taste, which may improve patient adherence and reduce the risk of misuse compared to the reference product (Suboxone®).

In large phase III trials lasting up to 28 days, Zubsolv® demonstrated high treatment retention rates and effectively reduced opioid cravings and withdrawal symptoms, making it a viable option for treating opioid dependence in adults and adolescents over 15 years old.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine/Naloxone (Zubsolv®): A Review in Opioid Dependence. Heo, YA., Scott, LJ.[2021]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820859

Extended-Release 7-Day Injectable Buprenorphine for ... Meaning Results of this study suggest that 7-day extended-release buprenorphine may be feasible in patients with opioid use disorder presenting ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0376871625002510

Extended-release injectable buprenorphine for the ... This prospective clinical cohort study found that among 25 patients with OUD at high risk of overdose who started XR-BUP in were followed in a low-barrier ...

3. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00488-1/fulltext

Superiority and cost-effectiveness of monthly extended ... Evaluated against the daily oral SoC, monthly BUP-XR is clinically superior, delivering greater abstinence from opioids, longer treatment ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06023459

Extended-release Buprenorphine Compared to Sublingual ... The measure for the main comparative effectiveness outcome is number of urine drug screen (UDS) results negative for opioids at scheduled assessments during ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12426361/

Extended‐release buprenorphine treatment for opioid use ... BUP‐XR was also associated with longer continuous opioid abstinence (95 days vs. 77 days; P = 0.005); reduced craving for opioids (various comparators; P < 0.05); ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39543001/

A Single-Dose Study to Evaluate the Relative ... A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of Monthly Extended-Release Buprenorphine at Alternative ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/210136Orig1s000RiskR.pdf

210136Orig1s000 - accessdata.fda.gov BRIXADI (buprenorphine) is an extended-release subcutaneous depot injection intended for the treatment of moderate to severe opioid use disorder (OUD) in ...

8. journals.lww.com journals.lww.com/journaladdictionmedicine/fulltext/9900/extended_release_buprenorphine_for_opioid_use.590.aspx

Extended-release Buprenorphine for Opioid Use Disorder ... Buprenorphine is a highly effective medication that is associated with a more than 50% reduction in all-cause mortality, though utilization of ...