Evidence map›Paper›PMID 30844878›Full record

Trial reportJournal of addiction medicine

Patient-centered Outcomes in Participants of a Buprenorphine Monthly Depot (BUP-XR) Double-blind, Placebo-controlled, Multicenter, Phase 3 Study.

Walter Ling, Vijay R Nadipelli, Caitlyn T Solem, Naoko A Ronquest, Yu-Chen Yeh, Susan M Learned, Vishaal Mehra, Christian Heidbreder

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of addiction medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05594121 (A Pragmatic, Multi-centre, Open-label, Randomized, 12-month, Parallel Group, Superiority Study to Compare the Effectiveness of Subcutaneous Buprenorphine Depot), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
6.0field-weighted citation impact, top 4% of its field
1 · What the graph read from it

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.

2 · The registry

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.

NCT05594121 phase4unknown statusnot on this map

A Pragmatic, Multi-centre, Open-label, Randomized, 12-month, Parallel Group, Superiority Study to Compare the Effectiveness of Subcutaneous Buprenorphine Depot (Sublocade®) vs Daily Sublingual Buprenorphine With Naloxone (Suboxone®) for the Treatment of Opioid Use Disorder

TypeinterventionalSponsorRoyal Victoria Hospital, CanadaRan2022 to 2024Enrolled90ConditionsModerate to Severe Opioid Use DisorderArmsExtended Release Subcutaneous Buprenorphine, Immediate Release Sublingual Buprenorphine
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

  1. Pooled it
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  7. The Socioeconomic Impact of Long-Acting Injectable Buprenorphine.ClinicoEconomics and outcomes research : CEOR · 2026
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  11. Content analysis of perceptions of combined pharmacobehavioral treatment for American Indian people with opioid use disorder.Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

Walter LingUCLA David Geffen School of Medicine, Department of Family Medicine, Center for Behavioral & Addiction Medicine, Los Angeles, CA (WL); Indivior Inc., Richmond, VA (VRN, SML, CH); Pharmerit International, Bethesda, MD (CTS); RTI Health Solutions, Research Triangle Park, NC (NAR); Pharmerit International, Newton, MA (YCY); Artemis Institute for Clinical Research, San Diego, CA (VM).
Vijay R Nadipelli
Caitlyn T Solem
Naoko A Ronquest
Yu-Chen Yeh
Susan M Learned
Vishaal Mehra
Christian Heidbreder
YY (China) · CNCourtesy Travel Service · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveOpioid use disorder (OUD) is associated with physical, social, psychological, and economic burden. This analysis assessed the effects of RBP-6000, referred to as BUP-XR (extended-release buprenorphine), a subcutaneously injected, monthly buprenorphine treatment for OUD compared with placebo on patient-centered outcomes measuring meaningful life changes.

methodsPatient-centered outcomes were collected in a 24-week, phase 3, placebo-controlled study assessing the efficacy, safety, and tolerability of BUP-XR 300/300 mg (6 × 300 mg) and 300/100 mg (2 × 300 mg followed by 4 × 100 mg) injections in treatment-seeking participants with moderate-to-severe OUD. Measures included the EQ-5D-5L, SF-36v2, Medication Satisfaction Questionnaire, employment/insurance status, and healthcare resource utilization (HCRU). Changes from baseline to end of study were compared across treatment arms, using mixed models for repeated measures.

resultsParticipants receiving BUP-XR (n = 389) versus placebo (n = 98) had significantly greater changes from baseline on the EQ-5D-5L index (300/300 mg: difference = 0.0636, P = 0.003), EQ-5D-5L visual analog scale (300/300 mg: difference = 5.9, P = 0.017; 300/100 mg: difference = 7.7, P = 0.002), and SF-36v2 physical component summary score (300/300 mg: difference = 3.8, P < 0.001; 300/100 mg: difference = 3.2, P = 0.002). Satisfaction was significantly higher for participants receiving BUP-XR 300/300 mg (88%, P < 0.001) and 300/100 mg (88%, P < 0.001) than placebo (46%). Employment and percentage of insured participants increased by 10.8% and 4.1% with BUP-XR 300/300 mg and 10.0% and 4.7% with 300/100 mg but decreased by 12.6% and 8.4% with placebo. Participants receiving BUP-XR compared with placebo had significantly fewer hospital days per person-year observed.

conclusionsThese results show the feasibility of measuring patient-centered life changes in substance use disorder clinical studies. Participants receiving up to 6 monthly injections of BUP-XR, compared with placebo, reported better health, increased medication satisfaction, increased employment, and decreased healthcare utilization.

Indexed as

Quality of LifeAdultAnalgesics, OpioidBuprenorphineDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleEmploymentFemaleHumansInjections, SubcutaneousInsurance, HealthLogistic ModelsMaleNarcotic AntagonistsOpioid-Related DisordersAnalgesics, OpioidBuprenorphineNarcotic Antagonists

Identifiers

PMID30844878
PMCPMC6844648
OpenAlexW2922501327

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.