Adding ultralow-dose naltrexone to oxycodone enhances and prolongs analgesia: A randomized, controlled trial of oxytrex

Journal of Pain

Volumn 6, Issue 6, 2005, Pages 392-399

  Chindalore, Vishala L ^a   Craven, Richard A ^b   Yu, K Peony ^c   Butera, Peter G ^c   Burns, Lindsay H ^c   Friedmann, Nadav ^c  

^a Anniston Medical Clinic   (United States)

^b East Coast Clinical Research   (United States)

^c Pain Therapeutics Inc   (United States)

Author keywords

Analgesia; Naltrexone; Opiate; Osteoarthritis; Oxycodone; Oxytrex

Indexed keywords

GUANINE NUCLEOTIDE BINDING PROTEIN; NALTREXONE; OPIATE ANTAGONIST; OPIATE RECEPTOR; OXYCODONE; OXYTREX; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; ANALGESIA; ARTHRALGIA; ARTICLE; CLINICAL TRIAL; CONNECTIVE TISSUE DISEASE; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DRUG DEPENDENCE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERANCE; FATIGUE; FEMALE; GASTROINTESTINAL DISEASE; HEADACHE; HUMAN; INSOMNIA; JOINT STIFFNESS; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; MUSCLE WEAKNESS; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; OSTEOARTHRITIS; PAIN; PATIENT; PHASE 2 CLINICAL TRIAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RECEPTOR AFFINITY; SCORING SYSTEM; SIDE EFFECT; SKIN DISEASE; SOMNOLENCE; SUBCUTANEOUS TISSUE DISORDER; SWEATING; VOMITING; XEROSTOMIA;

ADOLESCENT; ADULT; AGED; ANALGESIA; ANALGESICS, OPIOID; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG COMBINATIONS; DRUG SYNERGISM; FEMALE; HUMANS; MALE; MIDDLE AGED; NALTREXONE; NARCOTIC ANTAGONISTS; OSTEOARTHRITIS; OXYCODONE; PAIN; PAIN MEASUREMENT; PATIENT SATISFACTION; TREATMENT OUTCOME;

EID: 20444426267     PISSN: 15265900     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpain.2005.01.356     Document Type: Article

References (27)

1. N. Bellamy, W.W. Buchanan, C.H. Goldsmith, J. Campbell, L.W. Stitt Validation study of WOMAC A health status instrument for measuring clinically important relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee J Rheumatol 15 1988 1833 1840
2. M.S. Cepeda, J.M. Africano, A.M. Manrique, W. Fragoso, D.B. Carr The combination of low dose naloxone and morphine in PCA does not decrease opioid requirements in the postoperative period Pain 96 2002 73 79
3. M.S. Cepeda, H. Alvarez, O. Morales, D.B. Carr Addition of ultralow dose naloxone to postoperative morphine PCA Unchanged analgesia and opioid requirement but decreased incidence of opioid side effects Pain 107 2004 41 46
4. S.M. Crain, K.-F. Shen Opioids can evoke direct receptor-mediated excitatory effects on sensory neurons Trends Pharmacol Sci 11 1990 77 81
5. S.M. Crain, K.-F. Shen After chronic opioid exposure sensory neurons become supersensitive to the excitatory effects of opioid agonists and antagonists as occurs after acute elevation of GM1 ganglioside Brain Res 575 1992 13 24
6. S.M. Crain, K.-F. Shen Chronic morphine-treated sensory ganglion neurons remain supersensitive to the excitatory effects of naloxone for months after return to normal culture medium An in vitro model of "protracted opioid dependence." Brain Res 694 1995 103 110
7. S.M. Crain, K.-F. Shen Ultra-low concentrations of naloxone selectively antagonize excitatory effects of morphine on sensory neurons, thereby increasing its antinociceptive potency and attenuating tolerance/dependence during chronic cotreatment Proc Natl Acad Sci U S A 92 1995 10540 10544
8. S.M. Crain, K.-F. Shen Modulation of opioid analgesia, tolerance and dependence by Gs-coupled, GM1 ganglioside-regulated opioid receptor functions Trends Pharmacol Sci 19 1998 358 365
9. R.A. Cruciani, D. Lussier, D. Miller-Saultz, D.M. Arbuck Ultra-low dose oral naltrexone decreases side effects and potentiates the effect of methadone J Pain Symptom Manage 25 2003 491 494
10. T.J. Gan, B. Ginsberg, P.S.A. Glass, J. Fortney, R. Jhaveri, R. Perno Opioid-sparing effects of a low-dose infusion of naloxone in patient-administered morphine sulfate Anesthesiology 87 1997 1075 1081
11. S.K. Gandhi, J.W. Salmon, S.Z. Zhao, B.L. Lambert, P.R. Gore, K. Conrad Psychometric evaluation of the 12-item short-form health survey (SF-12) in osteoarthritis and rheumatoid arthritis clinical trials Clin Ther 23 2001 1080 1098
12. G.P. Joshi, L. Duffy, J. Chehade, J. Wesevich, N. Gajraj, E.R. Johnson Effects of prophylactic nalmefene on the incidence of morphine-related side effects in patients receiving intravenous patient-controlled analgesia Anesthesiology 90 1999 1007 1011
13. M.J. Kogan, K. Verebey, S.J. Mule Estimation of the systemic availability and other pharmacokinetic parameters of naltrexone in man after acute and chronic oral administration Res Commun Chem Pathol Pharmacol 18 1977 29 34
14. K. Leow, M. Smith, B. Williams, T. Cramond Single-dose and steady-state pharmacokinetics and pharmacodynamics of oxycodone in patients with cancer Clin Pharmacol Ther 52 1992 487 495
15. A. Matsumoto, T. Ma, N. Babul, H. Ahdieh, D. Lee Oxymorphine ER (20 mg and 40 mg) provides superior efficacy compared with placebo and oxycontin (20 mg) in pain associated with osteoarthritis Results of a randomized, controlled trial 2002 Proceedings of the 10th World Congress of Pain, San Diego, CA.
16. M.C. Olmstead, L.H. Burns Ultra-low-dose naltrexone suppresses rewarding effects of opiates and aversive effects of opiate withdrawal in rats Psychopharmacology 2005 In press.
17. C.V. Oddis New perspectives on osteoarthritis Am J Med 100 1996 10S 15S
18. P.M. Peloso, N. Bellamy, W. Bensen, G.T.D. Thomson, Z. Harsanyi, N. Babul, A.C. Darke Double blind randomized placebo control trial of controlled release codeine in the treatment of osteoarthritis of the hip or knee J Rheumatol 27 2000 764 771
19. J.G. Peyton, R.D. Altman The epidemiology of osteoarthritis R.W. Moskowitz D.S. Howe V.M. Goldberg H.J. Mankin Osteoarthritis Diagnosis and Medical Surgical Management 1993 WB Saunders Co Philadelphia, PA
20. K.J. Powell, N.S. Abul-Husn, A. Jhamandas, M.C. Olmstead, R.J. Beninger, K. Jhamandas Paradoxical effects of the opioid antagonist naltrexone on morphine analgesia, tolerance, and reward in rats JPET 300 2002 588 596
21. R. Poyhia, T. Seppala, K. Olkkola, E. Kalso The pharmacokinetics and metabolism of oxycodone after intramuscular and oral administration to healthy subjects Br J Clin Pharmacol 33 1992 617 621
22. R. Poyhia, A. Vainio, E. Kalso A review of oxycodone's clinical pharmacokinetics and pharmacodynamics J Pain Symptom Manage 8 1993 63 67
23. S.H. Roth, R.M. Fleischmann, F.X. Burch, R. Dietz, B. Bockow, R.J. Rapoport, J. Rutstein, P.G. Lacouture Around-the-clock, controlled-release oxycodone therapy for osteoarthritis-related pain Arch Intern Med 160 2000 853 860
24. K.F. Shen, S.M. Crain Dual opioid modulation of the action potential duration of mouse dorsal root ganglion neurons in culture Brain Res 491 1989 227 242
25. K.-F. Shen, S.M. Crain, P. Moate, R. Boston, A.W. de Kater, G.L. Schoenhard PTI-555, reverses and prevents morphine-induced tolerance and naloxone-precipitated withdrawal in mice chronically treated with morphine J Pain 3 suppl 1 2002 50
26. K.-F. Shen, S.M. Crain, P. Moate, R. Boston, A.W. de Kater, G.L. Schoenhard PTI-801, a novel formulation of oxycodone, shows absence of tolerance, physical dependence and naloxone-precipitated withdrawal effects in mice J Pain 3 suppl 1 2002 49
27. H.-Y. Wang, E. Friedman, M.C. Olmstead, L.H. Burns Ultra-low-dose naloxone suppresses opioid tolerance, dependence and associated changes in Mu opioid receptor-G protein coupling and Gβγ signaling Neuroscience 2005 In press