Evidence map›Paper›PMID 27012435›Full record

Trial reportDrug and alcohol dependence2016

Intranasal buprenorphine alone and in combination with naloxone: Abuse liability and reinforcing efficacy in physically dependent opioid abusers.

Sharon L Walsh, Paul A Nuzzo, Shanna Babalonis, Victoria Casselton, Michelle R Lofwall

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.9field-weighted citation impact, top 20% 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

7 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
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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

5 authors at 1 institution in 1 country.

Sharon L WalshCenter on Drug and Alcohol Research, University of Kentucky, 845 Angliana Avenue, Lexington, KY 40508, USA; Department of Behavioral Science, University of Kentucky, USA; Department of Psychiatry, University of Kentucky, USA; Department of Pharmacology, University of Kentucky, USA; Department of Pharmaceutical Sciences, University of Kentucky, USA. Electronic address: sharon.walsh@uky.edu.
Paul A NuzzoCenter on Drug and Alcohol Research, University of Kentucky, 845 Angliana Avenue, Lexington, KY 40508, USA; Department of Behavioral Science, University of Kentucky, USA. Electronic address: paul.nuzzo@uky.edu.
Shanna BabalonisCenter on Drug and Alcohol Research, University of Kentucky, 845 Angliana Avenue, Lexington, KY 40508, USA; Department of Behavioral Science, University of Kentucky, USA. Electronic address: shanna.babalonis@uky.edu.
Victoria CasseltonCenter on Drug and Alcohol Research, University of Kentucky, 845 Angliana Avenue, Lexington, KY 40508, USA. Electronic address: victoria.casselton@uky.edu.
Michelle R LofwallCenter on Drug and Alcohol Research, University of Kentucky, 845 Angliana Avenue, Lexington, KY 40508, USA; Department of Behavioral Science, University of Kentucky, USA; Department of Psychiatry, University of Kentucky, USA. Electronic address: michelle.lofwall@uky.edu.
University of Kentucky · US

Funding

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
NCATS NIH HHS UL1 TR000117NIDA NIH HHS R01 DA016718
6 · The paper itself

Abstract

backgroundBuprenorphine can be abused by the intranasal route. This study sought to examine the relative abuse liability and reinforcing efficacy of intranasal buprenorphine compared to intranasal buprenorphine/naloxone in opioid-dependent individuals.

methodsEleven healthy male and female volunteers physically dependent on short-acting opioids resided as inpatients during participation in this double blind, within subject, placebo-controlled study. Participants were maintained on oxycodone (30 mg/q.i.d., p.o.) throughout the 6-week study. Eight pairs of experimental sessions were conducted at ≥48 h intervals to examine the pharmacodynamic profile (Sample) and reinforcing efficacy (Self-administration the following day) of intranasal placebo, oxycodone (60 mg), buprenorphine (2, 8 & 16 mg) and buprenorphine/naloxone (2/0.5, 8/2 & 16/4 mg). Subjective, observer-rated and physiological measures were collected to assess the magnitude of opioid agonist and antagonist effects. A progressive ratio self-administration procedure assessed choices for drug versus money.

resultsAll active doses produced opioid agonist-like effects (e.g., increased ratings of "liking," and miosis) compared to placebo. The effects of buprenorphine and buprenorphine/naloxone were not reliably dose-dependent. Intranasal buprenorphine/naloxone elicited modest and transient opioid withdrawal-like effects in the first hour post-drug administration, while simultaneously blunting or blocking the early onset of agonist effects seen with buprenorphine alone. All active doses of buprenorphine were self-administered more than placebo, but buprenorphine/naloxone doses were not.

conclusionsThese data confirm that intranasal buprenorphine/naloxone has deterrent properties related to transient withdrawal effects that likely decrease its desirability for misuse compared to buprenorphine in opioid-dependent individuals maintained on short-acting opioids.

Indexed as

Administration, IntranasalAdolescentAdultAnalgesics, OpioidBuprenorphineBuprenorphine, Naloxone Drug CombinationDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedNaloxoneNarcotic AntagonistsNarcoticsOpiate Substitution TreatmentAnalgesics, OpioidBuprenorphineBuprenorphine, Naloxone Drug CombinationNaloxoneNarcotic AntagonistsNarcoticsOxycodoneAbuseBuprenorphineMisuseMu agonistOpioidOpioid withdrawal

Identifiers

PMID27012435
PMCPMC4833536
OpenAlexW2301816372

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.