Evidence map›Paper›PMID 27651514›Full record

Trial reportPain medicine (Malden, Mass.)2017

Oral Abuse Potential, Pharmacokinetics, and Safety of Once-Daily, Single-Entity, Extended-Release Hydrocodone (HYD) in Recreational Opioid Users.

Stephen C Harris, Alessandra Cipriano, Salvatore V Colucci, Ram P Kapil, Pierre Geoffroy, Talar Hopyan, Naama Levy-Cooperman

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Pain medicine (Malden, Mass.), 2017. 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
–field-weighted citation impact
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.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. Review
  7. Hydrocodone Bitartrate ER (HysinglaClinical drug investigation · 2016
    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.

Stephen C HarrisClinical Pharmacology, Purdue Pharma L.P., Stamford, Connecticut, USA.
Alessandra CiprianoClinical Pharmacology, Purdue Pharma L.P., Stamford, Connecticut, USA.
Salvatore V ColucciBiostatistics and Statistical Programming, Purdue Pharma L.P., Stamford, CT, USA.
Ram P KapilClinical Pharmacology, Purdue Pharma L.P., Stamford, Connecticut, USA.
Pierre GeoffroyEarly Phase INC Research, Toronto, Ontario, Canada.
Talar HopyanEarly Phase INC Research, Toronto, Ontario, Canada.
Naama Levy-CoopermanEarly Phase INC Research, Toronto, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesA once-daily, extended-release hydrocodone bitartrate tablet with abuse-deterrent properties (Hysingla ER [HYD]) is available for the treatment of chronic pain in appropriate patients. This study evaluated the oral abuse potential and pharmacokinetics (PK) of HYD intact, chewed, or milled to fine particles in comparison with hydrocodone solution or placebo.

designSingle-center, double-blind, randomized, five-period, five-treatment crossover study. SUBJECTS: Healthy adult, nondependent, recreational opioid users.

methodsForty subjects received orally administered treatments of hydrocodone 60 mg solution, HYD 60 mg intact, HYD 60 mg chewed, HYD 60 mg milled to fine particles, or placebo, separated by a five- to seven-day washout. Assessments over 36 hours postdose included subjective measures of drug liking and willingness to take drug again (assessed using visual analog scales [VAS]), pupillometry, PK, and safety measures.

resultsFollowing oral administration, HYD intact, HYD chewed, and HYD fine particles led to significantly lower "at this moment" drug liking compared with hydrocodone solution. HYD intact and chewed were significantly different from hydrocodone solution on overall drug liking, take drug again, and good effects. Pupil constriction, as measured by pupillometry, occurred later with HYD intact and HYD chewed than with hydrocodone solution. Across treatments (hydrocodone solution, HYD fine particles, HYD chewed, and HYD intact, respectively), mean C max and rate of absorption (C max /T max ) values decreased, respectively, and median T max values increased, respectively. Safety was consistent with the known effects of opioid agonists.

conclusionHYD demonstrated reduced oral abuse potential compared with hydrocodone solution in healthy adult, nondependent, recreational opioid users.

Indexed as

Administration, OralAdultAnalgesics, OpioidCross-Over StudiesDelayed-Action PreparationsDouble-Blind MethodDrug Administration ScheduleDrug CompoundingFemaleHumansHydrocodoneMaleMasticationMiddle AgedOpioid-Related DisordersYoung AdultAnalgesics, OpioidDelayed-Action PreparationsHydrocodoneAbuse DeterrentAbuse PotentialHYDHydrocodonePain

Identifiers

PMID27651514
PMCPMC5914330

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Registered trials

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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.