Buprenorphine for Opioid Use Disorder

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

240 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months.

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.

What data supports the effectiveness of the drug Extended-Release Buprenorphine for treating opioid use disorder?

Research shows that extended-release buprenorphine, which is a long-lasting form of the drug, is effective for treating opioid use disorder. It helps reduce misuse and nonadherence issues seen with daily oral forms, and studies have shown its long-term safety and effectiveness. ^{1 2 3 4 5}

Is extended-release buprenorphine safe for humans?

Extended-release buprenorphine is generally considered safe for treating opioid use disorder. Studies show it is effective in reducing opioid use and has a low risk of causing euphoria or intoxication. It is rarely found in fatal overdoses, indicating a favorable safety profile. ^{2 6 7 8 9}

How is extended-release buprenorphine different from other drugs for opioid use disorder?

Extended-release buprenorphine is unique because it is administered as a weekly, monthly, or six-monthly injection, which helps avoid daily dosing and reduces the risk of misuse and nonadherence compared to daily oral treatments. ^{1 2 4 5 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

References

1. 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]

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

Cost-Effectiveness of Buprenorphine-Naloxone Versus Extended-Release Naltrexone to Prevent Opioid Relapse. [2020]

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

18-Month efficacy and safety analysis of monthly subcutaneous buprenorphine injection for opioid use disorder: Integrated analysis of phase 3 studies. [2023]

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

Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial. [2020]

5. 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]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Continued Posttrial Benefits of Buprenorphine Extended Release: RECOVER Study Findings. [2023]

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

Buprenorphine Extended-Release Treatment for Opioid Use Disorder in the Postpartum Period. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

Buprenorphine infrequently found in fatal overdose in New York City. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Extended-release buprenorphine outcomes among treatment resistant veterans. [2022]