PMID- 21102969
OWN - NLM
STAT- MEDLINE
DCOM- 20110610
LR  - 20131121
IS  - 2150-1149 (Electronic)
IS  - 1533-3159 (Linking)
VI  - 13
IP  - 6
DP  - 2010 Nov-Dec
TI  - Reduced cognitive and psychomotor impairment with extended-release oxymorphone 
      versus controlled-release oxycodone.
PG  - 561-73
AB  - BACKGROUND: Opioids provide effective pain control, yet have risks including 
      adverse events (AEs) (e.g., constipation, nausea/vomiting, sedation) and 
      cognitive/psychomotor effects. OBJECTIVE: To compare cognitive and psychomotor 
      effects of oxymorphone extended release (OM-ER) versus oxycodone controlled 
      release (OC-CR). STUDY DESIGN: Randomized, double-blind, 5-way crossover SETTING: 
      Single inpatient research unit METHODS: Nondependent recreational opioid users 
      were administered single intact oral tablets of placebo, OM-ER (15 and 30 mg), 
      and OC-CR (30 and 60 mg), separated by a 7- to 21-day washout. The divided 
      attention (DA) test measured psychomotor impairment (e.g., manual tracking [e.g., 
      percentage over road], target accuracy [e.g., target hits], reaction time [hit 
      latency]). Visual analog scales measured alertness/drowsiness, 
      agitation/relaxation, and dizziness. Sedative, stimulant, and dysphoric effects 
      were measured using the Addiction Research Center Inventory 
      Pentobarbital-Chlorpromazine-Alcohol (PCAG), Benzedrine Group (BG), and Lysergic 
      Acid Diethylamide (LSD) scales, respectively. Comparisons were made between 
      equianalgesic doses (OM-ER 15 mg vs OC-CR 30 mg; OM-ER 30 mg vs OC-CR 60 mg), 
      within active drug doses, and between active drugs and placebo using least 
      squares (LS) mean difference of the peak maximum (Emax) or minimum (Emin) effect 
      using linear mixed model analysis of covariance. RESULTS: Thirty-five 
      participants received all 5 treatments. Peak cognitive and psychomotor impairment 
      (LS mean [SE]) was less with OM-ER than equianalgesic doses of OC-CR for reaction 
      time (Emax hit latency, longer if impaired; 571.2 [13.4] vs 588.1 ms [13.4], 
      P=0.03 for OM-ER 15 mg vs OC-CR 30 mg, respectively; 572.4 [13.4] vs 604.3 ms 
      [13.4], P=0.03 for OM-ER 15 mg vs OC-CR 30 mg, respectively; 572.4 [13.4] vs 
      604.3 ms [13.4], P<0.001 for OM-ER 30 mg vs OC-CR 60 mg, respectively); tracking 
      accuracy (Emin percentage over road, lower if impaired; 71.4 [2.4] vs 65.3 [2.4], 
      P=0.007; 69.9 [2.4] vs 59.4 [2.4], P<0.001), and target accuracy (Emin target 
      hits percentage, lower if impaired; 81.0 [3.1] vs 74.5 [3.1], P=0.02; 79.4 [3.1] 
      vs 66.1 [3.1], P<0.001). Several other DA measures showed that OC-CR, especially 
      60 mg, produced more psychomotor impairment than equianalgesic OM-ER. Compared to 
      OM-ER, OC-CR produced more dizziness (Emax, P<0.001 for OM-ER 15 mg vs OC-CR 30 
      mg and for OM-ER 30 mg vs OC-CR 60 mg), drowsiness (Emax, P<0.001 for both 
      equianalgesic dose groups), relaxation (Emin, P=0.003 for OM-ER 15 mg vs OC-CR 30 
      mg; P=0.001 for OM-ER 30 mg vs OC-CR 60 mg), dysphoria (Emax LSD, P<0.001 for 
      both equianalgesic dose groups), and sedation (Emax, PCAG; P<0.001 for both 
      equianalgesic dose groups) and less stimulation (BG, Emin; P=0.01 for OM-ER 15 mg 
      vs OC-CR mg; P<0.001 for OM-ER 30 mg vs OC-CR 60 mg). Several AEs occurred more 
      commonly with OC-CR than OM-ER (e.g., euphoria, nausea, somnolence, vomiting, 
      dizziness). LIMITATIONS: Participants were young, healthy volunteer nondependent 
      recreational drug users, and only single doses were evaluated. The effects of 
      tampering or higher doses were not assessed. CONCLUSION: Single oral intact low 
      and high doses of OM-ER produced less cognitive and psychomotor impairment plus 
      less sedation than equianalgesic OC-CR in this exploratory study. 
      ClinicalTrials.gov registration NCT00955110.
FAU - Schoedel, Kerri A
AU  - Schoedel KA
AD  - Kendle Early Stage, Toronto, ON, Canada. schoedel.kerri@kendle.com
FAU - McMorn, Stephen
AU  - McMorn S
FAU - Chakraborty, Bijan
AU  - Chakraborty B
FAU - Zerbe, Kathleen
AU  - Zerbe K
FAU - Sellers, Edward M
AU  - Sellers EM
LA  - eng
SI  - ClinicalTrials.gov/NCT00955110
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Pain Physician
JT  - Pain physician
JID - 100954394
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Delayed-Action Preparations)
RN  - 9VXA968E0C (Oxymorphone)
RN  - CD35PMG570 (Oxycodone)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Analgesics, Opioid/*administration & dosage/adverse effects
MH  - Cognition Disorders/*chemically induced/diagnosis/prevention & control
MH  - Cross-Over Studies
MH  - Delayed-Action Preparations/administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Oxycodone/*administration & dosage/adverse effects
MH  - Oxymorphone/*administration & dosage/adverse effects
MH  - Pain, Intractable/*drug therapy
MH  - Psychomotor Disorders/*chemically induced/diagnosis/prevention & control
MH  - Young Adult
EDAT- 2010/11/26 06:00
MHDA- 2011/06/11 06:00
CRDT- 2010/11/25 06:00
PHST- 2010/11/25 06:00 [entrez]
PHST- 2010/11/26 06:00 [pubmed]
PHST- 2011/06/11 06:00 [medline]
PST - ppublish
SO  - Pain Physician. 2010 Nov-Dec;13(6):561-73.