Clinical trial NCT00398034 - References

Pain — Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.

Citation(s)

•   Abs R, Verhelst J, Maeyaert J, Van Buyten JP, Opsomer F, Adriaensen H, Verlooy J, Van Havenbergh T, Smet M, Van Acker K
  Endocrine consequences of long-term intrathecal administration of opioids. J Clin Endocrinol Metab. 2000 Jun;85(6):2215-22. doi: 10.1210/jcem.85.6.6615.
•   Adams ML, Sewing B, Forman JB, Meyer ER, Cicero TJ
  Opioid-induced suppression of rat testicular function. J Pharmacol Exp Ther. 1993 Jul;266(1):323-8.
•   Afrasiabi MA, Flomm M, Friedlander H, Valenta LJ
  Endocrine studies in heroin addicts. Psychoneuroendocrinology. 1979;4(2):145-53. doi: 10.1016/0306-4530(79)90028-3. No abstract available.
•   American Pain Society, Guidelines for the Management of Acute and Cancer Pain
  4 ed. 1999, Glenview, IL: American Pain Society.
•   Anderson FH
  Osteoporosis in men. Int J Clin Pract. 1998 Apr-May;52(3):176-80.
•   Azizi F, Vagenakis AG, Longcope C, Ingbar SH, Braverman LE
  Decreased serum testosterone concentration in male heroin and methadone addicts. Steroids. 1973 Oct;22(4):467-72. doi: 10.1016/0039-128x(73)90002-0. No abstract available.
•   Bair MJ, Robinson RL, Katon W, Kroenke K
  Depression and pain comorbidity: a literature review. Arch Intern Med. 2003 Nov 10;163(20):2433-45. doi: 10.1001/archinte.163.20.2433.
•   Bolelli G, Lafisca S, Flamigni C, Lodi S, Franceschetti F, Filicori M, Mosca R
  Heroin addiction: relationship between the plasma levels of testosterone, dihydrotestosterone, androstenedione, LH, FSH, and the plasma concentration of heroin. Toxicology. 1979 Dec;15(1):19-29. doi: 10.1016/0300-483x(79)90016-7.
•   Brambilla F, Sacchetti E, Brunetta M
  Pituitary-gonadal function in heroin addicts. Neuropsychobiology. 1977;3(2-3):160-6. doi: 10.1159/000117601.
•   Catlin DH, Poland RE, Gorelick DA, Gerner RH, Hui KK, Rubin RT, Li CH
  Intravenous infusion of beta-endorphin increases serum prolactin, but not growth hormone or cortisol, in depressed subjects and withdrawing methadone addicts. J Clin Endocrinol Metab. 1980 Jun;50(6):1021-5. doi: 10.1210/jcem-50-6-1021.
•   Cicero TJ, Badger TM, Wilcox CE, Bell RD, Meyer ER
  Morphine decreases luteinizing hormone by an action on the hypothalamic-pituitary axis. J Pharmacol Exp Ther. 1977 Dec;203(3):548-55. No abstract available.
•   Cicero TJ, Badger TM
  A comparative analysis of the effects of narcotics, alcohol and the barbiturates on the hypothalamic-pituitary-gonadal axis. Adv Exp Med Biol. 1977;85B:95-115. doi: 10.1007/978-1-4615-9038-5_8.
•   Cicero TJ, Bell RD, Meyer ER, Schweitzer J
  Narcotics and the hypothalamic-pituitary-gonadal axix: acute effects on luteinizing hormone, testosterone and androgen-dependent systems. J Pharmacol Exp Ther. 1977 Apr;201(1):76-83.
•   Cicero TJ, Bell RD, Wiest WG, Allison JH, Polakoski K, Robins E
  Function of the male sex organs in heroin and methadone users. N Engl J Med. 1975 Apr 24;292(17):882-7. doi: 10.1056/NEJM197504242921703.
•   Cicero TJ, Meyer ER, Wiest WG, Olney JW, Bell RD
  Effects of chronic morphine administration on the reproductive system of the male rat. J Pharmacol Exp Ther. 1975 Mar;192(3):542-8.
•   Cicero TJ, Wilcox CE, Bell RD, Meyer ER
  Acute reductions in serum testosterone levels by narcotics in the male rat: stereospecificity, blockade by naloxone and tolerance. J Pharmacol Exp Ther. 1976 Aug;198(2):340-6.
•   Cicero TJ
  Effects of exogenous and endogenous opiates on the hypothalamic--pituitary--gonadal axis in the male. Fed Proc. 1980 Jun;39(8):2551-4.
•   Couzinet B, Schaison G
  The control of gonadotrophin secretion by ovarian steroids. Hum Reprod. 1993 Nov;8 Suppl 2:97-101. doi: 10.1093/humrep/8.suppl_2.97.
•   Crowley TJ, Simpson R
  Methadone dose and human sexual behavior. Int J Addict. 1978 Feb;13(2):285-95. doi: 10.3109/10826087809039281.
•   Cushman P Jr, Kreek MJ
  Methadone-maintained patients. Effect of methadone on plasma testosterone, FSH, LH, and prolactin. N Y State J Med. 1974 Oct;74(11):1970-3.
•   Cushman P Jr
  Plasma testosterone in narcotic addiction. Am J Med. 1973 Oct;55(3):452-8. doi: 10.1016/0002-9343(73)90202-7. No abstract available.
•   Cushman P Jr
  Sexual behavior in heroin addiction and methadone maintenance. Correlation with plasma luteinizing hormone. N Y State J Med. 1972 Jun 1;72(11):1261-5. No abstract available.
•   Daniell HW
  Hypogonadism in men consuming sustained-action oral opioids. J Pain. 2002 Oct;3(5):377-84. doi: 10.1054/jpai.2002.126790.
•   Daniell HW
  Narcotic-induced hypogonadism during therapy for heroin addiction. J Addict Dis. 2002;21(4):47-53. doi: 10.1300/J069v21n04_05.
•   Ebeling PR
  Osteoporosis in men. New insights into aetiology, pathogenesis, prevention and management. Drugs Aging. 1998 Dec;13(6):421-34. doi: 10.2165/00002512-199813060-00002.
•   Elhassan AM, Lindgren JU, Hultenby K, Bergstrom J, Adem A
  Methionine-enkephalin in bone and joint tissues. J Bone Miner Res. 1998 Jan;13(1):88-95. doi: 10.1359/jbmr.1998.13.1.88.
•   Finch PM, Roberts LJ, Price L, Hadlow NC, Pullan PT
  Hypogonadism in patients treated with intrathecal morphine. Clin J Pain. 2000 Sep;16(3):251-4. doi: 10.1097/00002508-200009000-00011.
•   Forman LJ, Tingle V, Estilow S, Cater J
  The response to analgesia testing is affected by gonadal steroids in the rat. Life Sci. 1989;45(5):447-54. doi: 10.1016/0024-3205(89)90631-0.
•   Frye CA, Seliga AM
  Testosterone increases analgesia, anxiolysis, and cognitive performance of male rats. Cogn Affect Behav Neurosci. 2001 Dec;1(4):371-81. doi: 10.3758/cabn.1.4.371.
•   Grossman A
  Brain opiates and neuroendocrine function. Clin Endocrinol Metab. 1983 Nov;12(3):725-46. doi: 10.1016/s0300-595x(83)80062-0.
•   Jarvik LF, Simpson JH, Guthrie D, Liston EH
  Morphine, experimental pain, and psychological reactions. Psychopharmacology (Berl). 1981;75(2):124-31. doi: 10.1007/BF00432173.
•   Khan C, Malik SA, Iqbal MA
  Testosterone suppression by heroin. J Pak Med Assoc. 1990 Jul;40(7):172-3. No abstract available.
•   Kley HK, Oellerich M, Wiegelmann W, Herrmann J, Rudorff KH, Nieschlag E, Kruskemper HL
  The effect of methadone on hypophyseal and peripheral glandular hormones during withdrawal. Horm Metab Res. 1977 Nov;9(6):484-8. doi: 10.1055/s-0028-1093505. No abstract available.
•   Lafisca S, Bolelli G, Franceschetti F, Filicori M, Flamigni C, Marigo M
  Hormone levels in methadone-treated drug addicts. Drug Alcohol Depend. 1981 Nov;8(3):229-34. doi: 10.1016/0376-8716(81)90066-1.
•   Malik SA, Khan C, Jabbar A, Iqbal A
  Heroin addiction and sex hormones in males. J Pak Med Assoc. 1992 Sep;42(9):210-2.
•   Martini L, Motta M, Piva F, Zanisi M
  LHRF, LHRH, GnRH: what controls the secretion of this hormone? Mol Psychiatry. 1997 Sep;2(5):373-6. doi: 10.1038/sj.mp.4000311.
•   Mendelson JH, Ellingboe J, Judson BA, Goldstein A
  Plasma testosterone and luteinizing hormone levels during levo-alpha-acetylmethadol maintenance and withdrawal. Clin Pharmacol Ther. 1984 Apr;35(4):545-7. doi: 10.1038/clpt.1984.75.
•   Mendelson JH, Ellingboe J, Keuhnle JC, Mello NK
  Effects of naltrexone on mood and neuroendocrine function in normal adult males. Psychoneuroendocrinology. 1978 Oct;3(3-4):231-6. doi: 10.1016/0306-4530(78)90013-6. No abstract available.
•   Mendelson JH, Ellingboe J, Kuehnle J, Mello NK
  Heroin and naltrexone effects on pituitary-gonadal hormones in man: tolerance and supersensitivity. NIDA Res Monogr. 1979;27:302-8. No abstract available.
•   Mendelson JH, Inturrisi CE, Renault P, Senay EC
  Effects of acetylmethadol on plasma testosterone. Clin Pharmacol Ther. 1976 Mar;19(3):371-4. doi: 10.1002/cpt1976193371.
•   Mendelson JH, Mello NK
  Plasma testosterone levels during chronic heroin use and protracted abstinence: study of Hong Kong addicts. NIDA Res Monogr. 1978;(19):142-8. No abstract available.
•   Mendelson JH, Mendelson JE, Patch VD
  Plasma testosterone levels in heroin addiction and during methadone maintenance. J Pharmacol Exp Ther. 1975 Jan;192(1):211-17.
•   Mendelson JH, Meyer RE, Ellingboe J, Mirin SM, McDougle M
  Effects of heroin and methadone on plasma cortisol and testosterone. J Pharmacol Exp Ther. 1975 Nov;195(2):296-302.
•   Miller K, Corcoran C, Armstrong C, Caramelli K, Anderson E, Cotton D, Basgoz N, Hirschhorn L, Tuomala R, Schoenfeld D, Daugherty C, Mazer N, Grinspoon S
  Transdermal testosterone administration in women with acquired immunodeficiency syndrome wasting: a pilot study. J Clin Endocrinol Metab. 1998 Aug;83(8):2717-25. doi: 10.1210/jcem.83.8.5051.
•   Mintz J, O'Hare K, O'Brien CP, Goldschmidt J
  Sexual problems of heroin addicts. Arch Gen Psychiatry. 1974 Nov;31(5):700-3. doi: 10.1001/archpsyc.1974.01760170088014. No abstract available.
•   Mirin SM, Meyer RE, Mendelson JH, Ellingboe J
  Opiate use and sexual function. Am J Psychiatry. 1980 Aug;137(8):909-15. doi: 10.1176/ajp.137.8.909.
•   Morley JE
  The endocrinology of the opiates and opioid peptides. Metabolism. 1981 Feb;30(2):195-209. doi: 10.1016/0026-0495(81)90172-4.
•   Murphy MR
  Methadone reduces sexual performances and sexual motivation in the male Syrian golden hamster. Pharmacol Biochem Behav. 1981 Apr;14(4):561-7. doi: 10.1016/0091-3057(81)90317-8.
•   Oyama T, Toyota M, Shinozaki Y, Kudo T
  Effects of morphine and ketamine anaesthesia and surgery on plasma concentrations of luteinizing hormone, testosterone and cortisol in man. Br J Anaesth. 1977 Oct;49(10):983-90. doi: 10.1093/bja/49.10.983.
•   Paice JA, Penn RD, Ryan WG
  Altered sexual function and decreased testosterone in patients receiving intraspinal opioids. J Pain Symptom Manage. 1994 Feb;9(2):126-31. doi: 10.1016/0885-3924(94)90166-x.
•   Passchier J, Rupreht J, Koenders ME, Olree M, Luitwieler RL, Bonke B
  Patient-controlled analgesia (PCA) leads to more postoperative pain relief, but also to more fatigue and less vigour. Acta Anaesthesiol Scand. 1993 Oct;37(7):659-63. doi: 10.1111/j.1399-6576.1993.tb03784.x.
•   Pedrazzoni M, Vescovi PP, Maninetti L, Michelini M, Zaniboni G, Pioli G, Costi D, Alfano FS, Passeri M
  Effects of chronic heroin abuse on bone and mineral metabolism. Acta Endocrinol (Copenh). 1993 Jul;129(1):42-5. doi: 10.1530/acta.0.1290042.
•   Perez-Castrillon JL, Olmos JM, Gomez JJ, Barrallo A, Riancho JA, Perera L, Valero C, Amado JA, Gonzalez-Macias J
  Expression of opioid receptors in osteoblast-like MG-63 cells, and effects of different opioid agonists on alkaline phosphatase and osteocalcin secretion by these cells. Neuroendocrinology. 2000 Sep;72(3):187-94. doi: 10.1159/000054586.
•   Portenoy RK
  Opioid therapy for chronic nonmalignant pain: a review of the critical issues. J Pain Symptom Manage. 1996 Apr;11(4):203-17. doi: 10.1016/0885-3924(95)00187-5.
•   Purohit V, Singh HH, Ahluwalia BS
  Failure of methadone-treated human testes to respond to the stimulatory effect of human chorionic gonadotrophin on testosterone biosynthesis in vitro. J Endocrinol. 1978 Aug;78(2):299-300. doi: 10.1677/joe.0.0780299. No abstract available.
•   Ragni G, De Lauretis L, Bestetti O, Sghedoni D, Gambaro V
  Gonadal function in male heroin and methadone addicts. Int J Androl. 1988 Apr;11(2):93-100. doi: 10.1111/j.1365-2605.1988.tb00984.x.
•   Ragni G, De Lauretis L, Gambaro V, Di Pietro R, Bestetti O, Recalcati F, Papetti C
  Semen evaluation in heroin and methadone addicts. Acta Eur Fertil. 1985 Jul-Aug;16(4):245-9.
•   Rajagopal A, Vassilopoulou-Sellin R, Palmer JL, Kaur G, Bruera E
  Hypogonadism and sexual dysfunction in male cancer survivors receiving chronic opioid therapy. J Pain Symptom Manage. 2003 Nov;26(5):1055-61. doi: 10.1016/s0885-3924(03)00331-2.
•   Rasheed A, Tareen IA
  Effects of heroin on thyroid function, cortisol and testosterone level in addicts. Pol J Pharmacol. 1995 Sep-Oct;47(5):441-4.
•   Rasmussen DD, Liu JH, Wolf PL, Yen SS
  Endogenous opioid regulation of gonadotropin-releasing hormone release from the human fetal hypothalamus in vitro. J Clin Endocrinol Metab. 1983 Nov;57(5):881-4. doi: 10.1210/jcem-57-5-881.
•   Rico H, Costales C, Cabranes JA, Escudero M
  Lower serum osteocalcin levels in pregnant drug users and their newborns at the time of delivery. Obstet Gynecol. 1990 Jun;75(6):998-1000.
•   Rigoni, G
  Drug Utilization for Immediate- and Modified Release Opioids in the U.S. in FDA Anesthesia, Life Support, and Addiction Drug Products Advisory Committee. 2003. Gaithersburg, Maryland.
•   Roberts LJ, Finch PM, Pullan PT, Bhagat CI, Price LM
  Sex hormone suppression by intrathecal opioids: a prospective study. Clin J Pain. 2002 May-Jun;18(3):144-8. doi: 10.1097/00002508-200205000-00002.
•   Smith DE, Moser C, Wesson DR, Apter M, Buxton ME, Davison JV, Orgel M, Buffum J
  A clinical guide to the diagnosis and treatment of heroin-related sexual dysfunction. J Psychoactive Drugs. 1982 Jan-Jun;14(1-2):91-9. doi: 10.1080/02791072.1982.10471916.
•   Stoffel EC, Ulibarri CM, Craft RM
  Gonadal steroid hormone modulation of nociception, morphine antinociception and reproductive indices in male and female rats. Pain. 2003 Jun;103(3):285-302. doi: 10.1016/s0304-3959(02)00457-8.
•   Su CF, Liu MY, Lin MT
  Intraventricular morphine produces pain relief, hypothermia, hyperglycaemia and increased prolactin and growth hormone levels in patients with cancer pain. J Neurol. 1987 Dec;235(2):105-8. doi: 10.1007/BF00718020.
•   von Graffenried B, del Pozo E, Roubicek J, Krebs E, Poldinger W, Burmeister P, Kerp L
  Effects of the synthetic enkephalin analogue FK 33-824 in man. Nature. 1978 Apr 20;272(5655):729-30. doi: 10.1038/272729a0. No abstract available.
•   Woody G, McLellan AT, O'Brien C, Persky H, Stevens G, Arndt I, Carroff S
  Hormone secretion in methadone-dependent and abstinent patients. NIDA Res Monogr. 1988;81:216-23. No abstract available.
•   Yen SS, Quigley ME, Reid RL, Ropert JF, Cetel NS
  Neuroendocrinology of opioid peptides and their role in the control of gonadotropin and prolactin secretion. Am J Obstet Gynecol. 1985 Jun 15;152(4):485-93. doi: 10.1016/s0002-9378(85)80162-9.
•   Yilmaz B, Konar V, Kutlu S, Sandal S, Canpolat S, Gezen MR, Kelestimur H
  Influence of chronic morphine exposure on serum LH, FSH, testosterone levels, and body and testicular weights in the developing male rat. Arch Androl. 1999 Nov-Dec;43(3):189-96. doi: 10.1080/014850199262481.

Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.

Details for clinical trial NCT00398034