Trial reportJournal of clinical psychopharmacology
Treating Opioid Use Disorder With a Monthly Subcutaneous Buprenorphine Depot Injection: 12-Month Safety, Tolerability, and Efficacy Analysis.
Trial report in Journal of clinical psychopharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
What it found
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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
23 citing papers in PubMed, 43 citations in OpenAlex.
- Rapid vs Standard Induction to Injectable Extended-Release Buprenorphine: A Randomized Clinical Trial.JAMA network open · 2025Trial
- 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
- 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.Clinical pharmacokinetics · 2021Trial
- Beyond treatment response: Injection-site reactions as part of the extended-release buprenorphine experience.Addiction (Abingdon, England) · 2026Article
- Inpatient initiation of long-acting injectable buprenorphine for adolescents and young adults with opioid use disorder.Journal of substance use and addiction treatment · 2026Article
- Review
- Enhancing Compliance Through Local Anesthesia in Extended-Release Buprenorphine Therapy: A Report of Two Cases.Cureus · 2026Article
- Phase-Inversion In Situ Systems: Problems and Prospects of Biomedical Application.Pharmaceutics · 2025Review
- Making long-acting treatment work: Tracing connections with extended-release buprenorphine depot through time.Drug and alcohol review · 2025Article
- Provider costs of treating opioid dependence with extended-release buprenorphine in Australia.Drug and alcohol review · 2025Article
- Case report: Local anesthesia with lidocaine infiltration for extended-release buprenorphine therapy.Frontiers in psychiatry · 2025Article
- Methadone and Buprenorphine in the Perioperative Setting: A Review of the Literature.Current pain and headache reports · 2024Review
- Perceptions of extended-release buprenorphine among people who received medication for opioid use disorder in jail: a qualitative study.Addiction science & clinical practice · 2024Article
- Reduced emergency department use among insured individuals receiving extended-release buprenorphine in a health system setting.Drug and alcohol dependence reports · 2024Article
- Buprenorphine for Chronic Pain Management: a Narrative Review.Current pain and headache reports · 2023Review
- Integrating long-acting injectable treatment to improve medication adherence among persons living with HIV and opioid use disorder: study protocol.Addiction science & clinical practice · 2023Article
- Long-Acting Buprenorphine Formulations as a New Strategy for the Treatment of Opioid Use Disorder.Journal of clinical medicine · 2023Article
- History of the discovery, development, and FDA-approval of buprenorphine medications for the treatment of opioid use disorder.Drug and alcohol dependence reports · 2023Review
- Negative allosteric modulation of CBPharmacological research · 2022Article
- Buprenorphine exposure levels to optimize treatment outcomes in opioid use disorder.Frontiers in pharmacology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBUP-XR (RBP-6000 or SUBLOCADE) is the first Food and Drug Administration-approved subcutaneously administered monthly extended-release buprenorphine medication for the treatment of moderate or severe opioid use disorder. The primary objective of this phase III study was to assess the long-term safety, tolerability, and efficacy of BUP-XR.
methodsThis open-label multicenter study in adults with moderate or severe opioid use disorder enrolled 257 participants from a previously conducted placebo-controlled, double-blind phase III study (rollover group) and 412 de novo participants not previously treated with BUP-XR. Participants received an initial injection of BUP-XR 300 mg and subsequent monthly 300 mg or 100 mg flexible doses. By study end, participants received up to 12 injections.
resultsOverall, 66.8% of participants reported more than 1 treatment-emergent adverse event (TEAE). Injection-site TEAEs (13.2% of participants) were mostly mild or moderate in severity. There were no clinically meaningful changes in safety assessments. An integrated analysis of the double-blind and open-label study participants showed that the incidence of TEAEs, including injection-site TEAEs, was lower in the second 6 months of treatment versus the first 6 months. After 12 months of treatment, 61.5% of the rollover participants and 75.8% of the de novo participants were abstinent. Retention rates after 12 months were 50.6% for the participants who initiated BUP-XR in the double-blind study and 50.5% for de novo participants.
conclusionsThis study demonstrates that the clinical benefits and acceptable safety profile of BUP-XR demonstrated in the 6-month double-blind study are sustained over a 12-month open-label study, with lower incidence of TEAEs in the second 6 months of treatment.
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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.