Subjective, psychomotor, and physiological effects profile of hydrocodone/acetaminophen and oxycodone/acetaminophen combination products.
OBJECTIVE
To compare within the same individuals two typically prescribed doses of hydrocodone/acetaminophen and oxycodone/acetaminophen products for their subjective, psychomotor, and physiological effects in healthy volunteers.


METHODS
A randomized, placebo-controlled, double-blind, crossover, six-session clinical laboratory study, enrolling 16 healthy participants (27.2 +/- 4.4 years of age). Participants received 5 mg hydrocodone/325 mg acetaminophen, 10 mg hydrocodone/650 mg acetaminophen, 5 mg oxycodone/325 mg acetaminophen, 10 mg oxycodone/650 mg acetaminophen, 650 mg acetaminophen, and placebo in different sessions.


RESULTS
Oxycodone/acetaminophen and hydrocodone/acetaminophen at the 5-mg opioid dose produced few subjective effects and no significant psychomotor impairment. Relative to placebo, the 10-mg oxycodone combination produced a wider spectrum of subjective effects that were statistically significant than did the 10-mg hydrocodone combination. The 10-mg oxycodone combination also produced a greater degree of miosis than the 10-mg hydrocodone combination. Both drug combinations impaired psychomotor performance at the 10-mg opioid dose.


CONCLUSIONS
The results of this study, albeit in pain-free individuals, may inform physicians who prescribe, and pharmacists who dispense, two widely prescribed opioid/acetaminophen combination products on how patients might be feeling from the drugs. Patients prescribed either of the two opioid/acetaminophen combination products may experience a number of subjective effects, including effects that would contraindicate certain activities, and they should be cautioned accordingly. However, this study documented rather large differences in magnitude of subjective effects between 10 mg oxycodone/650 mg acetaminophen and placebo, and physicians and pharmacists, and ultimately patients, should be aware of these differences.
Zacny
James P
JP
Department of Anesthesia and Critical Care, University of Chicago, Chicago, Illinois 60637, USA. jzacny@dacc.uchicago.edu
Gutierrez
Sandra
S
D000082:Acetaminophen / Q000008:administration & dosage / Q000009:adverse effects*; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000009:adverse effects; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006853:Hydrocodone / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D010098:Oxycodone / Q000008:administration & dosage / Q000009:adverse effects*; D015990:Placebo Effect; D011596:Psychomotor Disorders / Q000139:chemically induced* / Q000175:diagnosis; D011597:Psychomotor Performance / Q000187:drug effects*; D016896:Treatment Outcome
D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D004338:Drug Combinations; D000082:Acetaminophen; D006853:Hydrocodone; D010098:Oxycodone