Evidence map›Paper›PMID 35524938›Full record

ArticlePain and therapy2022

Pharmacokinetics of Buprenorphine Buccal Film and Orally-administered Oxycodone in a Respiratory Study: An Analysis of Secondary Outcomes from a Randomized Controlled Trial.

Lynn R Webster, Jacqueline Cater, Thomas Smith

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pain and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03996694 (A Randomized, Double-Blind, Double Dummy, 6-Period, Placebo-Controlled, Crossover Study to Explore and Compare the Ventilatory Response to Hypercapnia), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.0field-weighted citation impact, top 14% 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.

NCT03996694 phase1completednot on this map

A Randomized, Double-Blind, Double Dummy, 6-Period, Placebo-Controlled, Crossover Study to Explore and Compare the Ventilatory Response to Hypercapnia (VRH), of Belbuca, Oxycodone Hydrochloride (HCl) and Placebo in Recreational Opioid Users

TypeinterventionalSponsorBioDelivery Sciences InternationalRan2019 to 2019Enrolled19ConditionsRespiratory DepressionArmsBelbuca 300 µg, Belbuca 600 µg, Belbuca 900 µg, Oxycodone 30 mg, Oxycodone 60 mg
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Article
  3. Respiratory Depression Associated with Opioids: A Narrative Review.Current treatment options in oncology · 2024
    Review
  4. Review
  5. Review
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

3 authors at 2 institutions in 1 country.

Lynn R WebsterUS Center of Policy, 1455 Pennsylvania Ave NW, Suite 400, Washington, DC, 20004, USA. lrwebstermd@gmail.com.ORCID http://orcid.org/0000-0001-8609-9424
Jacqueline CaterICON Plc, Philadelphia, PA, USA.
Thomas SmithBioDelivery Sciences International, Inc, Raleigh, NC, USA.
BioDelivery Sciences International (United States) · USPublic Policy Institute of California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate pharmacokinetic (PK) parameters and oxygen saturation as markers of abuse potential after administration of buprenorphine buccal film (BBF) and immediate-release (IR) oxycodone.

methodsThis was a secondary analysis of data from a phase I randomized controlled trial. A total of 19 healthy subjects who self-identified as recreational opioid users were enrolled, with 15 completing the study. Subjects were administered 300, 600, and 900 µg BBF; 30 and 60 mg orally-administered oxycodone; and placebo. For PK analysis, blood samples were collected before dosing and at 0.5, 1, 2, 3, 4, and 6 h postdose. Respiratory drive/ventilatory response to hypercapnia and oxygen saturation were evaluated before dosing and up to 8 h after administration of test drugs.

resultsMedian time to maximum concentration (T

conclusionThese results indicate that BBF may have a decreased risk of abuse and respiratory depression compared with the full µ-opioid receptor agonist oxycodone.

trial registrationClinicalTrials.gov identifier, NCT03996694.

Indexed as

Abuse quotientBuprenorphineOxygen saturationPharmacokinetics

Identifiers

PMID35524938
PMCPMC9314471
OpenAlexW4229063331

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.