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

Trial Summary

What is the purpose of this trial?

This application describes a 3-year, randomized controlled trial. Eligible, consenting adults (N=200) with existing sublingual buprenorphine (SLB) prescriptions who enter Middlesex County House of Corrections (MCHOC) as pre-trial detainees will be randomized at admission on a 1:1 basis to be inducted onto extended-release buprenorphine (XRB) at the time of admission (experimental condition) or remain in SLB (E-TAU; all participants will also receive naloxone). The two approaches will be compared with regard to (1) the percentage of participants released from jail with at least 7 days of buprenorphine in their system, (2) percentage of participants continuing MOUD treatment in the community, and (3) infractions related to buprenorphine diversion.

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 data supports the effectiveness of the drug Buprenorphine for treating opioid use disorder in jail?

Research shows that extended-release buprenorphine (XRB) is effective in maintaining treatment adherence and reducing opioid use among people leaving jail. Studies comparing XRB to other treatments like extended-release naltrexone suggest that XRB is at least as effective in helping individuals stay on their medication and avoid relapse. ^{1 2 3 4 5}

Is buprenorphine safe for humans?

Buprenorphine, including its extended-release form, has been studied for safety in various conditions, such as opioid use disorder and chronic pain. These studies generally support its safety for human use, although specific safety data for jail settings is limited. ^{1 4 6 7 8}

How is the drug Buprenorphine unique for treating opioid use disorder in jail?

Extended-Release Buprenorphine (XRB) is unique because it provides a sustained monthly treatment, which is particularly beneficial for people transitioning from jail to the community, helping to maintain treatment adherence and reduce the risk of relapse. ^{1 4 9 10 11}

Research Team

David Farabee, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

A clinical protocol of a comparative effectiveness trial of extended-release naltrexone versus extended-release buprenorphine with individuals leaving jail. [2022]

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

Thrice-weekly supervised dosing with the combination buprenorphine-naloxone tablet is preferred to daily supervised dosing by opioid-dependent humans. [2019]

3. United States 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Perceptions and experiences toward extended-release buprenorphine among persons leaving jail with opioid use disorders before and during COVID-19: an in-depth qualitative study. [2022]

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

Long-acting buprenorphine vs. naltrexone opioid treatments in CJS-involved adults (EXIT-CJS). [2023]

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

Factors of Interest in Extended-Release Buprenorphine: Comparisons Between Incarcerated and Non-Incarcerated Patients with Opioid Use Disorder. [2022]

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

Long-term safety and analgesic efficacy of buprenorphine buccal film in patients with moderate-to-severe chronic pain requiring around-the-clock opioids. [2022]

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

Comparison of Treatment Retention of Adults With Opioid Addiction Managed With Extended-Release Buprenorphine vs Daily Sublingual Buprenorphine-Naloxone at Time of Release From Jail. [2022]

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

Buprenorphine/Naloxone (Zubsolv®): A Review in Opioid Dependence. [2021]

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

Stability Study of a Compounded Sublingual Buprenorphine Solution for Neonatal Opioid Withdrawal Syndrome. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Sublingual Buprenorphine/Naloxone and Multi-Modal Management for High-Risk Chronic Pain Patients. [2021]