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

Summary

The purpose of this pilot study is to test the effects of testosterone replacement on pain, fatigue, mood, cognition and libido in hypogonadal men on long-term opioid therapy for chronic pain.

Timeline

Start

2006-10-30

Primary completion

2007-09-06

Completion

2007-09-06

Publications

• Background American Pain Society, Guidelines for the Management of Acute and Cancer Pain. 4 ed. 1999, Glenview, IL: American Pain Society.
• Background 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.
• Background 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.
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• Background 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.
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• Background Daniell HW. Hypogonadism in men consuming sustained-action oral opioids. J Pain. 2002 Oct;3(5):377-84. doi: 10.1054/jpai.2002.126790.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
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• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
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• Background 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.
• Background 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.
• Background Grossman A. Brain opiates and neuroendocrine function. Clin Endocrinol Metab. 1983 Nov;12(3):725-46. doi: 10.1016/s0300-595x(83)80062-0.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
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• Background 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.
• Background 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.
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• Background 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.
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Drugs

Indications