Evidence map›Paper›PMID 23446076›Full record

Trial reportThe Clinical journal of pain2014

The effect of repeated intramuscular alfentanil injections on experimental pain and abuse liability indices in healthy males.

David Andrew Tompkins, Michael T Smith, George E Bigelow, Ruin Moaddel, Swarajya Lakshmi Vatem Venkata, Eric C Strain

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Clinical journal of pain, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00991809 (A Pilot Study of Prolonged, Intermittent Exposure to Alfentanil on Opioid-Induced Hyperalgesia in Healthy Volunteers), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 32% 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.

NCT00991809 nacompletednot on this map

A Pilot Study of Prolonged, Intermittent Exposure to Alfentanil on Opioid-Induced Hyperalgesia in Healthy Volunteers

TypeinterventionalSponsorJohns Hopkins UniversityRan2009 to 2010Enrolled22ConditionsHyperalgesiaArmsAlfentanil, Diphenhydramine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

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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

6 authors at 3 institutions in 1 country.

David Andrew TompkinsDepartments of *Psychiatry and Behavioral Sciences, Behavioral Pharmacology Research Unit †Psychiatry and Behavioral Sciences, Behavioral Sleep Medicine Program, Johns Hopkins University School of Medicine ‡Intramural Research Program, National Institute on Aging, Baltimore, MD.
Michael T Smith
George E Bigelow
Ruin Moaddel
Swarajya Lakshmi Vatem Venkata
Eric C Strain
Behavioral Pharma (United States) · USNational Institute on Aging · USJohns Hopkins University · US

Funding

Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
HUMAN BEHAVIORAL PHARMACOLOGY OF SUBSTANCE ABUSET32DA007209 · NIDA · JOHNS HOPKINS UNIVERSITY · PI Eric C. Strain, Elise M Weerts · 1985 to 2026
$12.9M
Mentoring of Clinical Investigators in Patient Oriented ResearchK24DA023186 · NIDA · JOHNS HOPKINS UNIVERSITY · PI STRAIN, ERIC C. · 2007 to 2016
$1.8M
Optimizing Pain Treatment while Reducing Abuse Liability in Opioid DependenceK23DA029609 · NIDA · JOHNS HOPKINS UNIVERSITY · PI TOMPKINS, DAVID ANDREW · 2012 to 2016
$929k
Intramural NIH HHSNCATS NIH HHS UL1 TR001079NIDA NIH HHS 1K24DA023186NIDA NIH HHS 5T32 DA07209NIDA NIH HHS K23 DA029609NIDA NIH HHS K24 DA023186NIDA NIH HHS T32 DA007209
6 · The paper itself

Abstract

objectiveOpioid-induced hyperalgesia (OIH), increased sensitivity to noxious stimuli after repeated opioid exposures, has been demonstrated in preclinical studies. However, there is no accepted, prospective model of OIH after repeated opioid exposures currently available in humans. This study assessed a potential prospective OIH model.

methodsDouble-blind intramuscular injections of a short-acting opioid (alfentanil 15 mcg/kg; N=8) were compared to active placebo (diphenhydramine 25 mg; N=3) on cold and pressure pain testing and standard abuse liability measures in eight 10-hour sessions (1 injection/session) over 4 to 5 weeks in healthy, pain-free males. Decreases from session baseline pain threshold (PThr) and tolerance (PTol) were calculated to represent hyperalgesia, and were assessed both within and across sessions.

resultsMean decreases in cold PTol were seen in the alfentanil group at 180 minutes (-3.8 s, ±26.5) and 480 minutes (-1.63 s, ±31.5) after drug administration. There was a trend for differences between conditions on cold PThr hyperalgesia but not for pressure PThr. Alfentanil participants had greater mean ratings on Liking and High visual analog scales at peak effects (30 min), but these scores did not change across sessions. DISCUSSION: Repeated alfentanil exposures over 4 to 5 weeks resulted in within session decreases in cold pain tolerance from baseline but these differences were not substantially different from diphenhydramine controls. The results did not support the phenomenon of OIH in this model, although definitive conclusions regarding the existence of OIH in humans likely requires a larger sample size or an alternative model.

Indexed as

AdolescentAdultAlfentanilAnalgesics, OpioidDose-Response Relationship, DrugDouble-Blind MethodHumansHyperalgesiaInjections, IntramuscularMaleMiddle AgedOpioid-Related DisordersPainPain ThresholdRisk FactorsTreatment OutcomeAlfentanilAnalgesics, Opioid

Identifiers

PMID23446076
PMCPMC3676462
OpenAlexW2015187054

What OpenQuestion holds

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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.