Extended Release Buprenorphine for Opioid Use Disorder
(EXHITENTRE Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Overseen byGavin Bart, MD,PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: Hennepin Healthcare Research Institute
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study is a multi-site open-label randomized comparative effectiveness trial of a 28-day formulation of extended-release buprenorphine (XR-BUP) versus treatment as usual (TAU) for hospitalized patients with a moderate or severe opioid use disorder (OUD) seen by an addiction consultation service (ACS) and agreeing to initiate a medication for OUD (MOUD). Participants will be randomly assigned to XR-BUP or TAU to be received within 72 hours of anticipated hospital discharge. Follow up will occur at approximately 34, 90, and 180 days following hospital discharge.
Do I have to stop taking my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have taken a long-acting opioid other than buprenorphine in the three days before randomization or if you have received maintenance MOUD in the 14 days before hospitalization.
What data supports the idea that Extended Release Buprenorphine for Opioid Use Disorder is an effective drug?
The available research shows that Extended Release Buprenorphine is an effective drug for treating opioid use disorder. One study found that it can be more effective than daily treatments like methadone or regular buprenorphine, as it reduces the risk of misuse and helps people stick to their treatment plan. Another study highlighted that people continued to benefit from the drug even 18 months after stopping it. This suggests that Extended Release Buprenorphine not only helps in the short term but also has lasting positive effects.
12345What safety data exists for extended-release buprenorphine for opioid use disorder?
Safety data for extended-release buprenorphine, including formulations like Sublocade, Brixadi, and Buvidal, indicate that these treatments are generally safer than sublingual buprenorphine due to reduced risks of overdose and misuse. The RECOVER study showed continued benefits 18 months post-treatment. Concerns exist about coercive use, but these formulations are appreciated for reducing daily intake burdens and aiding in treatment retention. Sublocade is approved for monthly use in the USA, with studies comparing the safety of different doses (100 mg vs. 300 mg) for opioid-injecting patients.
14678Is the drug Extended Release Buprenorphine a promising treatment for opioid use disorder?
Yes, Extended Release Buprenorphine is a promising treatment for opioid use disorder. It is effective and can be more convenient than daily treatments because it is given as a weekly or monthly injection. This can help reduce misuse and make it easier for people to stick to their treatment plan.
12349Eligibility Criteria
This trial is for adults over 18 with moderate or severe opioid use disorder who are hospitalized and willing to start medication treatment. They must speak English well enough for consent and not have serious medical conditions that could interfere with the study or make it unsafe.Inclusion Criteria
Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study
I am 18 years old or older.
Meet Diagnostic and Statistical Manual (DSM-5) criteria for moderate or severe OUD
+2 more
Exclusion Criteria
I have a severe alcohol or benzodiazepine addiction that can't be treated quickly.
I have been on medication for opioid use disorder up to 14 days before being hospitalized.
Currently pregnant
+9 more
Participant Groups
The study compares a new 28-day extended-release buprenorphine (XR-BUP) with usual treatments in patients seen by an addiction service at the hospital. Participants will be randomly assigned to either XR-BUP or standard care before leaving the hospital, followed up after discharge.
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionalExperimental Treatment1 Intervention
Single subcutaneous injection of a 28-day formulation of extended-release buprenorphine within 72 hours of anticipated hospital discharge.
Group II: Treatment as UsualActive Control1 Intervention
Community standard of care that includes initiation of either methadone, sublingual (SL) buprenorphine, or naltrexone prior to hospital discharge.
Extended Release Buprenorphine is already approved in United States, European Union, Australia, United States for the following indications:
🇺🇸 Approved in United States as Brixadi for:
- Moderate to severe opioid use disorder
🇪🇺 Approved in European Union as Buvidal for:
- Opioid dependence
🇦🇺 Approved in Australia as Buvidal for:
- Opioid dependence
🇺🇸 Approved in United States as Sublocade for:
- Moderate to severe opioid use disorder
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hennepin Healthcare Research InstituteMinneapolis, MN
University of Pittsburgh Medical CenterPittsburgh, PA
Boston UniversityBoston, MA
Massachusetts General HospitalBoston, MA
More Trial Locations
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Who Is Running the Clinical Trial?
Hennepin Healthcare Research InstituteLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
The Emmes Company, LLCIndustry Sponsor
References
Continued Posttrial Benefits of Buprenorphine Extended Release: RECOVER Study Findings. [2023]This analysis describes participants' opioid use disorder (OUD) outcomes for 18 months after discontinuing extended-release buprenorphine injection (BUP-XR, SUBLOCADE).
Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial. [2020]Buprenorphine is an efficacious, widely used treatment for opioid use disorder (OUD). Daily oral transmucosal formulations can be associated with misuse, diversion, and nonadherence; these limitations may be obviated by a sustained release formulation.
Superiority and cost-effectiveness of monthly extended-release buprenorphine versus daily standard of care medication: a pragmatic, parallel-group, open-label, multicentre, randomised, controlled, phase 3 trial. [2023]Daily methadone maintenance or buprenorphine treatment is the standard-of-care (SoC) medication for opioid use disorder (OUD). Subcutaneously injected, extended-release buprenorphine (BUP-XR) may be more effective-but there has been no superiority evaluation.
Subcutaneous Extended-Release Buprenorphine Use in Pregnancy. [2022]Opioid use disorder (OUD) in pregnancy is managed by medication-assisted treatment. Sublingual buprenorphine is one option, but subcutaneous extended-release buprenorphine (Sublocade®) is an alternate form administered in monthly injections. Through an extensive literature search, we did not find any prior publication on the use of Sublocade in pregnancy.
[New slow-release buprenorphine formulations for optimization of opioid substitution]. [2020]Opioid maintenance treatment with methadone or buprenorphine is an established first-line treatment for opioid dependence. In addition to the novel weekly and monthly subcutaneously injectable buprenorphine depot CAM 2038 (Buvidal®), which is already available in Germany, two other long-acting buprenorphine formulations may be introduced in the near future: the monthly depot formulation RBP-6000 (Sublocade™) and a 6-month buprenorphine depot implant (Probuphine™). Basic pharmacological and clinical data of these three medications are given and possible clinical applications are discussed.
[Prolonged-release buprenorphine formulations: Perspectives for clinical practice]. [2022]Buprenorphine and methadone are the two main opioids agonist treatments approved for opioid use disorder. Buprenorphine is a partial agonist of the mu-opioid receptors, which has been merely available through sublingual form until now. In practice, the use of buprenorphine is smoother than that of methadone, and it induces reduced risks of overdose. However, sublingual buprenorphine also exposes to risks (e.g., withdrawal, misuse) and constraints (e.g., daily intake). Three new galenic formulations of prolonged-release buprenorphine (PRB) are being commercialized and should allow some improvements in patients' comfort and safety. This narrative review aims to describe the main technical features and efficacy and safety data of these PRBs, as well as patients' and professionals' expectancies and concerns, using data of the scientific literature and the regulatory texts. PRBs consist of one subcutaneous implant and two subcutaneous injection depots. Sixmo®/Probuphine® is a six-month-long implant which needs to be surgically placed and removed and is approved for subjects previously treated with a maximum daily dose of 8mg of sublingual buprenorphine, and can be used only for two successive periods of six months before the subject needs to be switched back to sublingual form. Sublocade® is a one-month-long depot formulation that is indicated in switch from sublingual buprenorphine, and which proposes only two dose schemes, i.e., 100 and 300mg monthly. Buvidal®/Brixadi® is a one-week- or one-month-long depot formulation with multiple dosages, which can be used in initiation or in switched from sublingual formulations. While opioid users report some concerns with a risk of coercive use of long-acting forms of buprenorphine, both users and professionals deem that these new specialties could be particularly appreciated in stabilized patients bothered with the daily intake of the treatments, or specific situations at risk of treatment dropout (e.g., following hospital discharge or prison release).
Prolonged-release buprenorphine formulations: Perspectives for clinical practice. [2021]Buprenorphine and methadone are the two main opioid agonist treatments approved for opioid use disorder. Buprenorphine is a partial agonist of the mu opioid receptors, which has been merely available through sublingual form until now. In practice, the use of buprenorphine is smoother than that of methadone, and it induces reduced risks of overdose. However, sublingual buprenorphine also exposes to risks (e.g., withdrawal, misuse) and constraints (e.g., daily intake). Three new galenic formulations of prolonged-release buprenorphine (PRB) are being commercialized and should allow some improvements in patients' comfort and safety. This narrative review aims to describe the main technical features and efficacy and safety data of these PRBs, as well as patients' and professionals' expectancies and concerns, using data of the scientific literature and the regulatory texts. PRBs consist of one subcutaneous implant and two subcutaneous injection depots. Sixmo®/Probuphine® is a six-month-long implant which needs to be surgically placed and removed and is approved for subjects previously treated with a maximum daily dose of 8mg of sublingual buprenorphine, and can be used only for two successive periods of six months before the subject needs to be switched back to sublingual form. Sublocade® is a one-month-long depot formulation that is indicated in switch from sublingual buprenorphine, and which proposes only two dose schemes, i.e., 100 and 300mg monthly. Buvidal®/Brixadi® is a one-week- or one-month-long depot formulation with multiple dosages, which can be used in initiation or in switched from sublingual formulations. While opioid users report some concerns with a risk of coercive use of long-acting forms of buprenorphine, both users and professionals deem that these new specialties could be particularly appreciated in stabilized patients bothered with the daily intake of the treatments, or specific situations at risk of treatment dropout (e.g., following hospital discharge or prison release).
Examining the benefit of a higher maintenance dose of extended-release buprenorphine in opioid-injecting participants treated for opioid use disorder. [2023]Label="BACKGROUND" NlmCategory="BACKGROUND">BUP-XR (SUBLOCADE®) is the first buprenorphine extended-release subcutaneous injection approved in the USA for monthly treatment of moderate-to-severe opioid use disorder (OUD). Among patients with OUD, those who inject or use high doses of opioids likely require higher doses of buprenorphine to maximize treatment efficacy. The objective of this analysis was to compare the efficacy and safety of 100-mg versus 300-mg maintenance doses of BUP-XR in OUD patients who inject opioids.
Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial. [2022]Buprenorphine treatment for opioid use disorder may be improved by sustained-release formulations.