Evidence map›Paper›PMID 30531478›Full record

Trial reportJournal of clinical psychopharmacology

Assessment of the Abuse Potential of Cebranopadol in Nondependent Recreational Opioid Users: A Phase 1 Randomized Controlled Study.

Karin Göhler, Marta Sokolowska, Kerri A Schoedel, Robert Nemeth, Elke Kleideiter, Isabella Szeto, Marie-Henriette Eerdekens

Open access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical psychopharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
2.1field-weighted citation impact, top 13% 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

26 citing papers in PubMed, 44 citations in OpenAlex.

  1. Trial
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  7. The influence of drug class on reward in substance use disorders.Pharmacology, biochemistry, and behavior · 2024
    Review
  8. Review
  9. Article
  10. Cebranopadol for the Treatment of Chronic Pain.Current pain and headache reports · 2023
    Review
  11. Review
  12. Review
  13. Article
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  15. Review
  16. Article
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  18. Potential therapeutic targets for the treatment of opioid abuse and pain.Advances in pharmacology (San Diego, Calif.) · 2022
    Review
  19. Article
  20. 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

7 authors at 1 institution in 1 country.

Karin Göhler
Marta SokolowskaMedical Affairs and Center for Abuse Prevention and Evaluation, Grünenthal USA, Morristown, NJ.
Kerri A SchoedelINC Research Early Phase, Toronto, Ontario, Canada (currently Altreos Research Partners, Inc).
Robert NemethData Sciences-Biostatistics, and.
Elke Kleideiter
Isabella SzetoINC Research Early Phase, Toronto, Ontario, Canada (currently Altreos Research Partners, Inc).
Marie-Henriette EerdekensClinical Science Pain, Grünenthal GmbH, Aachen, Germany.
Grünenthal Group (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCebranopadol is a nociceptin/orphanin FQ peptide/opioid receptor agonist with central antinociceptive activity. We hypothesize that this novel mechanism of action may lead to a lower risk of abuse compared with pure μ-opioid peptide receptor agonists.

methodsWe conducted a single-dose, nested-randomized, double-blind crossover study in nondependent recreational opioid users to evaluate the abuse potential of single doses of cebranopadol relative to hydromorphone immediate release and placebo. The study consisted of a qualification phase and a 7-period treatment phase (cebranopadol 200, 400, and 800 μg; hydromorphone 8 and 16 mg; and 2 placebos). The primary end point was the peak effect of drug liking at this moment, measured by visual analog scale (VAS). Various secondary end points (eg, VAS rating for good drug effects, high, bad drug effects, take drug again, drug similarity, and pupillometry) were also investigated.

resultsForty-two subjects completed the study. Cebranopadol 200 and 400 μg did not differentiate from placebo on the abuse potential assessments and generated smaller responses than hydromorphone. Responses observed with cebranopadol 800 μg were similar to hydromorphone 8 mg and smaller than hydromorphone 16 mg. The maximum effect for VAS drug liking at this moment was delayed compared with hydromorphone (3 and 1.5 hours, respectively). Cebranopadol administration was safe; no serious adverse events or study discontinuation due to treatment-emergent adverse events occurred.

conclusionsThese results confirm our hypothesis that cebranopadol, a nociceptin/orphanin FQ peptide/opioid receptor agonist, has lower abuse potential than hydromorphone immediate release, a pure μ-opioid peptide agonist.

Indexed as

AdolescentAdultAnalgesics, OpioidCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodDrug UsersFemaleHumansHydromorphoneIndolesMaleMiddle AgedSpiro CompoundsSubstance Abuse DetectionYoung Adult6'-fluoro-4',9'-dihydro-N,N-dimethyl-4-phenylspiro(cyclohexane-1,1'(3'H)-pyrano(3,4-b)indol)-4-amineAnalgesics, OpioidHydromorphoneIndolesSpiro Compounds

Identifiers

PMID30531478
PMCPMC6319565
OpenAlexW2903805609

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.