Buprenorphine for Opioid Use Disorder

Not currently recruiting at 1 trial location

Overseen By Michael Gordon, DPA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Friends Research Institute, Inc.

Must be taking: Buprenorphine

Must not be taking: Methadone, Naltrexone, Antipsychotics, Antidepressants

Disqualifiers: Liver disease, Heart disease, Suicidal ideation, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two forms of buprenorphine, a treatment for opioid use disorder (OUD), to determine which is more effective for individuals being released from jail. Participants will receive either an extended-release form, injected monthly, or a sublingual form, taken under the tongue. The goal is to assess how well these treatments support recovery after leaving jail. The study seeks adults in jail with a history of moderate-to-severe OUD who plan to live in Baltimore after release. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for OUD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently receiving non-buprenorphine medication for opioid use disorder in jail, like methadone or naltrexone. Also, if you are on medications that may affect heart rhythm, you might not be eligible.

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

Research has shown that extended-release buprenorphine (XR-B), also known as BRIXADI, is generally safe for treating opioid use disorder. Studies have found that many patients tolerate it well. The FDA has approved it for treating moderate to severe opioid use disorder, indicating its safety for use.

However, some precautions are necessary. Combining buprenorphine with medications like benzodiazepines (often used for anxiety) or drugs that slow brain activity can increase the risk of side effects, such as breathing problems or overdose.

Overall, while extended-release buprenorphine is considered safe for most people, following medical advice is crucial, especially when taking other medications. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for opioid use disorder?

Researchers are excited about extended-release buprenorphine (XR-B) for opioid use disorder because it offers a unique delivery method that could improve treatment adherence and outcomes. Unlike standard treatments like sublingual buprenorphine, which require daily dosing, XR-B is administered less frequently, starting with weekly doses and transitioning to a monthly injection. This extended-release formulation ensures a more consistent level of medication in the body, reducing the risk of relapse due to missed doses and potentially enhancing the effectiveness of opioid blockade. By simplifying the dosing schedule, XR-B may improve patient convenience and long-term recovery success.

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

Research has shown that extended-release buprenorphine (XR-B), which participants in this trial may receive, effectively treats opioid use disorder (OUD). One study found that people at high risk of overdose achieved good results after starting XR-B, as drug tests confirmed their ability to stay off opioids. Another study found that taking XR-B once a week is practical for people with OUD. Meanwhile, sublingual buprenorphine (SL-B), another treatment option in this trial, has also effectively reduced opioid use. Both treatments have shown promise in helping people with OUD manage their condition. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults in a large metropolitan jail with moderate-to-severe opioid use disorder (OUD) who are soon to be released. Participants will continue treatment after release and attend follow-up visits up to 12 months.

Inclusion Criteria

Individuals who are pre-trial and/or sentenced who are completing their sentence in the community

Willingness to enroll in XR-B or SL-B treatment in jail and continue in the community

I have a history of moderate to severe opioid use disorder or was in a treatment program before being incarcerated.

Exclusion Criteria

Liver function test levels greater than 5 times normal

I was unable to pass the study's enrollment quiz.

Currently receiving non-buprenorphine MOUD in jail (methadone, naltrexone)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment in Jail

Participants receive either extended-release buprenorphine (XR-B) or sublingual buprenorphine (SL-B) while in jail

4 weeks

Weekly dosing adjustments based on response

Post-release Treatment

Participants continue buprenorphine treatment for 6 months after release from jail

6 months

Safety Visit

A safety visit is conducted to monitor participants' health and treatment adherence

1 visit at 7 months

Long-term Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Extended-Release Buprenorphine

Trial Overview The study compares two forms of buprenorphine: extended-release (XR-B) versus sublingual (SL-B). It's an open-label trial, meaning everyone knows which treatment they're getting, with participants randomly assigned to either group.

How Is the Trial Designed?

Group I: extended-release buprenorphine (XR-B) Experimental Treatment 1 Intervention

Participants will receive sublingual (sl; taken under the tongue) buprenorphine/naloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine/naloxone. If they tolerate sl buprenorphine, on day 4 they will be administered an 8 mg dose of BRIXADI on day 5 (if they do not tolerate sl buprenorphine/naloxone we will extend sl dosing). During week two of dosing, they will receive 16 mg dose of BRIXADI will be given, based on the participant's response to the previous dose. During week three of dosing, they will receive a 24 mg dose of BRIXADI. During week four they will be administered a monthly dose of 64mg, 96mg, or 128mg. In all cases, the dose selected will be based on their response to the previous weeks' dose. We will endeavor to get you on the 96 mg or 128 mg monthly dose as there is a lack of opioid blockade data for the 64 mg monthly dose.

Group II: sublingual buprenorphine (SL-B) Active Control 1 Intervention

Participants will receive sublingual (sl; taken under the tongue) buprenorphine/naloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine/naloxone.

Who Is Running the Clinical Trial?

Friends Research Institute, Inc.

Lead Sponsor

Trials

60

Recruited

22,500+

Published Research Related to This Trial

In a study of 26 high-risk patients receiving Buprenorphine Extended-Release (BUP-XR), 81% maintained treatment with six or more monthly injections, indicating strong retention in a challenging population.

BUP-XR was associated with significant reductions in emergency department visits, hospitalization days, non-prescribed opioid use, and homelessness, suggesting it effectively supports patients with opioid use disorder despite a high mortality risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended-release buprenorphine outcomes among treatment resistant veterans. Cotton, AJ., Lo, K., Kurtz, FB., et al.[2022]

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]

In a study involving 570 adults with opioid use disorder, buprenorphine-naloxone was found to be more cost-effective than extended-release naltrexone, being preferred in 97% of cases at 24 weeks and 85% at 36 weeks based on quality-adjusted life-years (QALYs).

The analysis suggests that buprenorphine-naloxone is the better first-line treatment option, especially for patients needing detoxification before starting extended-release naltrexone, although the study had limitations such as a relatively short follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Buprenorphine-Naloxone Versus Extended-Release Naltrexone to Prevent Opioid Relapse. Murphy, SM., McCollister, KE., Leff, JA., et al.[2020]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40459195/

Transition to Extended-release Buprenorphine Injectable ... For Bup-XR-S studies, 75 patients transitioned to Bup-XR-S within 24 hours. Of patients, 4% experienced withdrawal symptoms requiring additional ...

2. 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 ...

3. 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 ...

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. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.70106

Extended‐release buprenorphine treatment for opioid use ... Three outcome measures from the trial's dataset were used descriptively: (1) fortnightly clinic visit administered TimeLine Follow-Back ...

6. brixadihcp.com brixadihcp.com/about-brixadi/

BRIXADI® (buprenorphine) extended-release injection for ... BRIXADI is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal ...

7. brixadi.com brixadi.com/pdfs/brixadi-prescribing-information.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION ... Concomitant use of buprenorphine and benzodiazepines or other CNS depressants increases the risk of adverse reactions including respiratory depression, overdose ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/210136Orig1s000lbl.pdf

Approval [Rx ONLY] - accessdata.fda.gov The withdrawal syndrome is milder than that seen with full agonists and may be delayed in onset [see Drug Abuse and Dependence (9.2, 9.3)].