Positive and negative subjective effects of extended-release oxymorphone versus controlled-release oxycodone in recreational opioid users

Kerri A. Schoedel, PhD; Stephen McMorn, PhD; Bijan Chakraborty, MStat; Susan L. Potts, MS; Kathleen Zerbe, RN; Edward M. Sellers, MD, PhD

doi:10.5055/jom.2011.0061

Authors

Kerri A. Schoedel, PhD
Stephen McMorn, PhD
Bijan Chakraborty, MStat
Susan L. Potts, MS
Kathleen Zerbe, RN
Edward M. Sellers, MD, PhD

DOI:

https://doi.org/10.5055/jom.2011.0061

Keywords:

adverse effects, drug users, euphoria, opioid, oxycodone, oxymorphone, pharmacodynamics, pharmacokinetics, pupillary reflex, Subjective Drug Value

Abstract

Objective: To compare the subjective effects of oxymorphone extended release (OM-ER ) versus oxycodone controlled release (OC-CR ).
Design: Randomized, double-blind, crossover study.
Setting: Inpatient unit.
Subjects: Healthy, nondependent recreational opioid users.
Interventions: Single intact oral tablets that were placebo or contained OM-ER (15 and 30 mg) or OC-CR (30 and 60 mg). Doses were representative of mid-range doses for chronic pain and were calculated using an established opioid conversion table.
Main outcome measures: Visual Analog Scales, Subjective Drug Value (SDV), and Addiction Research Center Inventory (ARCI) measured positive, negative, and balance effects and pupillometry. Equianalgesic comparisons were between OM-ER 15 mg versus OC-CR 30 mg (low doses) and OM-ER 30 mg versus OC-CR 60 mg (high doses).
Results: Thirty-five subjects received all five treatments. Positive subjective effects were lower for OM-ER 15 mg versus OC-CR 30 mg and for OM-ER 30 mg versus OC-CR 60 mg in ARCI Morphine Benzedrine Group (p ≤ 0.01 for both), Good Effects (p < 0.001 for both), Rush (p < 0.001 for both), and High VAS (p < 0.001 for both). Nausea was higher with OC-CR (p ≤ 0.02), and Bad Effects were higher for OC-CR 60 mg versus OM-ER 30 mg (p < 0.001). Balance effects were lower for OM-ER versus OC-CR (Drug Liking, p < 0.001; Overall Drug Liking, p ≤ 0.006; SDV, p ≤ 0.008), except for Take Drug Again (p < 0.001 for OC-CR 30 mg versus OM-ER 15 mg; p = 0.18 for high-dose group). Euphoric mood, nausea, somnolence, vomiting, and dizziness were more common with OC-CR than OM-ER.
Limitations: Single-dose design; use of healthy, recreational opioid users.
Conclusions: At equianalgesic doses, single oral intact OM-ER produced lower positive, negative, and balance subjective effects than OC-CR , indicating that analgesic potency may not necessarily be reflected in subjective/objective effects.

Author Biographies

Kerri A. Schoedel, PhD

Kendle Early Stage, Toronto, Ontario, Canada.

Stephen McMorn, PhD

Endo Pharmaceuticals Inc., Chadds Ford, Pennsylvania.

Bijan Chakraborty, MStat

Kendle Early Stage, Toronto, Ontario, Canada.

Susan L. Potts, MS

Endo Pharmaceuticals Inc., Chadds Ford, Pennsylvania.

Kathleen Zerbe, RN

Endo Pharmaceuticals Inc., Chadds Ford, Pennsylvania.

Edward M. Sellers, MD, PhD

Kendle Early Stage, Toronto, Ontario, Canada; Department of Pharmacology, University of Toronto, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.

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