Trial reportClinical pharmacokinetics2021
Population Pharmacokinetics of a Monthly Buprenorphine Depot Injection for the Treatment of Opioid Use Disorder: A Combined Analysis of Phase II and Phase III Trials.
Trial report in Clinical pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 48 citations in OpenAlex.
- A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of Monthly Extended-Release Buprenorphine at Alternative Injection Locations in Adult Participants with Opioid Use Disorder.Clinical drug investigation · 2024Trial
- Efficacy of transdermal buprenorphine patch for managing withdrawal symptoms in patients with cancer physically dependent on prescription opioids.The oncologist · 2024Trial
- Examining the benefit of a higher maintenance dose of extended-release buprenorphine in opioid-injecting participants treated for opioid use disorder.Harm reduction journal · 2023Trial
- Discontinuing extended-release buprenorphine: Participant experiences from a mixed-methods observational study.Drug and alcohol dependence reports · 2026Article
- How should low-threshold and primary care clinics prepare to provide long-acting injectable buprenorphine? A qualitative implementation study of patient and staff perspectives.Research square · 2026Article
- Exploring the Italian Experience with Long-Acting Buprenorphine Formulations (LAIB) for the Treatment of Opioid Use Disorder: A Series of Narrative Interviews.International journal of environmental research and public health · 2026Article
- Reconsidering the usefulness of using long-acting injectable buprenorphine as a tapering tool: a case report of delayed withdrawal months after last dose.Frontiers in psychiatry · 2026Article
- Optimal buprenorphine exposure to treat patients with opioid use disorder in the era of fentanyl and polysubstance use.Frontiers in pharmacology · 2026Article
- Buvidal/Brixadi - a long-acting injectable buprenorphine formulation for the treatment of opioid dependence.Pain management · 2025Review
- Long-Acting injectable buprenorphine PLGA microparticle formulation.International journal of pharmaceutics · 2025Article
- Monthly buprenorphine depot injection (SUBLOCADE®) for opioid use disorder during pregnancy.The American journal on addictions · 2025Article
- Pharmacokinetics and Breast Milk Transfer to Infants of Subcutaneous Extended-Release Buprenorphine for the Treatment of Individuals with Opioid Use Disorder.Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine · 2025Article
- Rapid intravenous symptom-inhibiting fentanyl induction (SIFI) to optimize rotation onto oral opioid agonist therapy among individuals who use unregulated fentanyl: protocol for an open-label, single arm clinical trial.Addiction science & clinical practice · 2025Article
- Phase-Inversion In Situ Systems: Problems and Prospects of Biomedical Application.Pharmaceutics · 2025Review
- Characterizing withdrawal from long-acting injectable buprenorphine: An observational case series.Drug and alcohol dependence reports · 2025Article
- Buprenorphine adherence among a prospective cohort of homeless-experienced adults with opioid use disorder.Drug and alcohol dependence · 2025Article
- Social Listening for Patient Experiences With Stopping Extended-Release Buprenorphine: Content Analysis of Reddit Messages.Journal of medical Internet research · 2025Article
- Development and preclinical testing of a naloxone prodrug depot for extended protection against opioid overdose.Nature communications · 2025Article
- Extended-Release Buprenorphine Could Overcome Barriers to Medical Treatment of Opioid Use Disorder in At-Risk Populations.HCA healthcare journal of medicine · 2025Article
- Tapering and withdrawing opioids: guidance informed by fundamental principles to minimise withdrawal symptoms.Therapeutic advances in psychopharmacology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBUP-XR (a.k.a. RBP-6000 or SUBLOCADE™) is an extended-release subcutaneous buprenorphine formulation for the treatment of opioid use disorder. BUP-XR was designed to provide sustained buprenorphine exposure throughout the monthly dosing interval, at concentrations sufficient to control all aspects of the disease (withdrawal, craving, and blockade of opioid subjective effects).
objectivesTo characterize the population pharmacokinetics of BUP-XR based on phase II and phase III data and to evaluate whether target therapeutic concentrations were reached with the dosing regimens evaluated in the phase III program.
methodsThe population pharmacokinetic analysis included 570 subjects with opioid use disorder who received up to 12 monthly BUP-XR injections following induction with sublingual buprenorphine.
resultsIn phase III studies, target therapeutic concentrations of buprenorphine were achieved from the first injection and maintained over the entire treatment duration. Buprenorphine plasma concentration-time profiles were well described by a two-compartment model, with first-order absorption for sublingual buprenorphine and a dual absorption submodel for BUP-XR. A covariate analysis evaluated the effects of subjects' demographic characteristics, laboratory data, and genetic status regarding buprenorphine-metabolizing enzymes. Only two covariates, body mass index and body weight, were retained in the final model. Overall, their effects were not of sufficient magnitude to justify a dose adjustment. Finally, pharmacokinetic simulations showed that buprenorphine plasma concentrations decreased slowly after discontinuation of treatment and that a 2-week occasional delay in dosing would not impact efficacy, which translated into labeling claims. DISCUSSION: In conclusion, the present analysis led to the development of a robust population pharmacokinetic model and confirms the ability of BUP-XR to deliver and maintain therapeutic plasma concentrations over the entire treatment duration.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.