Evidence map›Paper›PMID 21395892›Full record

Trial reportAddiction (Abingdon, England)2011

The pharmacodynamic and pharmacokinetic profile of intranasal crushed buprenorphine and buprenorphine/naloxone tablets in opioid abusers.

Lisa S Middleton, Paul A Nuzzo, Michelle R Lofwall, David E Moody, Sharon L Walsh

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Addiction (Abingdon, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
7.2field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 76 citations in OpenAlex.

  1. Trial
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  6. Intranasal oxycodone self-administration in non-dependent opioid abusers.Experimental and clinical psychopharmacology · 2012
    Trial
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Treating Chronic Pain with Buprenorphine-The Practical Guide.Current treatment options in oncology · 2021
    Review
  13. Review
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Article
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

5 authors at 2 institutions in 1 country.

Lisa S MiddletonDepartments of Behavioral Science, University of Kentucky, Lexington, KY 40502, USA. lisa.middleton@uky.edu
Paul A Nuzzo
Michelle R Lofwall
David E Moody
Sharon L Walsh
University of Kentucky · USUniversity of Utah · US

Funding

Kentucky Center for Clinical and Translational ScienceUL1TR001998 · NCATS · UNIVERSITY OF KENTUCKY · PI HARTMANN, KATHERINE E, KERN, PHILIP A · 2016 to 2025
$34.2M
Kentucky Center for Clinical and Translational ScienceUL1TR000117 · NCATS · UNIVERSITY OF KENTUCKY · PI KERN, PHILIP A · 2012 to 2015
$13.3M
Licit &Illicit Opioids: Comparative Studies in HumansR01DA016718 · NIDA · UNIVERSITY OF KENTUCKY · PI WALSH, SHARON L. · 2004 to 2023
$8.6M
Training in Drug Abuse Related Research.T32DA016176 · NIDA · UNIVERSITY OF KENTUCKY · PI DWOSKIN, LINDA P · 2004 to 2020
$4.0M
KENTUCKY CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCEUL1RR033173 · NCRR · UNIVERSITY OF KENTUCKY · PI KERN, PHILIP A · 2011 to 2011
$3.5M
NCATS NIH HHS UL1 TR000117NCATS NIH HHS UL1 TR001998NCRR NIH HHS UL1 RR033173NIDA NIH HHS R01 DA016718NIDA NIH HHS R01-DA016718NIDA NIH HHS T32 DA016176
6 · The paper itself

Abstract

aimsSublingual buprenorphine and buprenorphine/naloxone are efficacious opioid dependence pharmacotherapies, but there are reports of their diversion and misuse by the intranasal route. The study objectives were to characterize and compare their intranasal pharmacodynamic and pharmacokinetic profiles.

designA randomized, double-blind, placebo-controlled, cross-over study.

settingAn in-patient research unit at the University of Kentucky.

participantsHealthy adults (n = 10) abusing, but not physically dependent on, intranasal opioids. MEASUREMENTS: Six sessions (72 hours apart) tested five intranasal doses [0/0, crushed buprenorphine (2, 8 mg), crushed buprenorphine/naloxone (2/0.5, 8/2 mg)] and one intravenous dose (0.8 mg buprenorphine/0.2 mg naloxone for bioavailability assessment). Plasma samples, physiological, subject- and observer-rated measures were collected before and for up to 72 hours after drug administration.

findingsBoth formulations produced time- and dose-dependent increases on subjective and physiological mu-opioid agonist effects (e.g. 'liking', miosis). Subjects reported higher subjective ratings and street values for 8 mg compared to 8/2 mg, but these differences were not statistically significant. No significant formulation differences in peak plasma buprenorphine concentration or time-course were observed. Buprenorphine bioavailability was 38-44% and T(max) was 35-40 minutes after all intranasal doses. Naloxone bioavailability was 24% and 30% following 2/0.5 and 8/2 mg, respectively.

conclusionsIt is difficult to determine if observed differences in abuse potential between intranasal buprenorphine and buprenorphine/naloxone are clinically relevant at the doses tested. Greater bioavailability and faster onset of pharmacodynamic effects compared to sublingual administration suggests a motivation for intranasal misuse in non-dependent opioid abusers. However, significant naloxone absorption from intranasal buprenorphine/naloxone administration may deter the likelihood of intranasal misuse of buprenorphine/naloxone, but not buprenorphine, in opioid-dependent individuals.

Indexed as

Administration, IntranasalAdultAnalysis of VarianceArea Under CurveBiological AvailabilityBuprenorphineCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodDrug CombinationsFemaleHumansInjections, IntravenousMaleNaloxoneNarcotic AntagonistsBuprenorphineDrug CombinationsNaloxoneNarcotic AntagonistsTablets

Identifiers

PMID21395892
PMCPMC3776483
OpenAlexW1839254548

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.