性腺功能减退阿片类药物治疗慢性疼痛患者睾酮替代疗法的镇痛效果：一项初步研究。
2023年10月11日 更新者：Chris Cardozo、James J. Peters Veterans Affairs Medical Center
这项初步研究的目的是测试睾酮替代对长期阿片类药物治疗慢性疼痛的性腺功能减退男性的疼痛、疲劳、情绪、认知和性欲的影响。
研究概览
详细说明
阿片类药物越来越多地用于治疗非恶性慢性疼痛，最近一次估计是在 2002 年，接受治疗的患者多达 5 到 1000 万。
阿片类药物的副作用，如疲劳、性欲减退、认知障碍和性功能障碍，早已为人所知，并且与男性性腺功能减退症的症状非常相似。
许多研究表明，长期服用阿片类药物的男性受试者性腺功能减退症的患病率很高。
这项初步研究的目的是，在接受阿片类药物治疗慢性疼痛的性腺功能减退男性中：1) 确定 TRT 对疼痛的影响； 2) 确定 TRT 对疲劳的影响； 3) 确定 TRT 对情绪的影响； 4) 确定 TRT 对认知的影响和 5) 表征 TRT 对性功能障碍的影响。
本研究是一项随机、安慰剂对照、为期 6 周的初步研究。
研究类型
介入性
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New York
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Bronx、New York、美国、10468
- 招聘中
- James J. Peters VAMC
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接触：
- David AN Siegel, M.D.
- 电话号码：212-433-0606
- 邮箱：david.siegel2@med.va.gov
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首席研究员：
- David AN Siegel, M.D.
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副研究员：
- Christopher Cardoza, M.D.
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副研究员：
- William Bauman, M.D.
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副研究员：
- Ann Spungen, Ed.D
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
不
描述
纳入标准：
- 成年男性患者（18岁以上60岁以下）
- 接受超过 20 IV 吗啡当量/天且上个月剂量变化 <20%。
- AM 总睾酮 <300 ng/dL
- 报告“过去一周内最严重的疼痛”在 11 分制的数字量表上大于 4。
排除标准：
- 女性
- 控制不佳、有症状、活跃的医学或精神问题（例如，艾滋病毒、肝炎、糖尿病、癌症、良性前列腺肥大、药物滥用、重度抑郁症）
- 会损害患者给予知情同意或遵守方案要求的能力的神经或精神疾病。
- 前列腺癌病史、直肠指检异常发现或 PSA 大于 4.0 ng/m
- 红细胞增多症史
- 肾或肝功能障碍
- 血细胞比容 >55%
- 已知对透皮睾酮凝胶过敏史。
- 直肠指检时异常。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
研究衡量的是什么？
主要结果指标
结果测量 |
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• 确定睾酮替代疗法是否可以改善接受阿片类药物治疗的患有慢性疼痛的性腺功能减退男性的疼痛控制。
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次要结果测量
结果测量 |
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在接受阿片类药物治疗的患有慢性疼痛的性腺功能减退男性中，确定睾酮替代疗法 (TRT) 是否会：
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减少阿片类药物的需求。
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改善疲劳
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改善抑郁症
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改善性功能。
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提高认知
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确定响应者对 TRT 镇痛作用的比例
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Christopher P Cardozo, M.D.、James J. Peters VAMC
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Daniell HW. Hypogonadism in men consuming sustained-action oral opioids. J Pain. 2002 Oct;3(5):377-84. doi: 10.1054/jpai.2002.126790.
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- American Pain Society, Guidelines for the Management of Acute and Cancer Pain. 4 ed. 1999, Glenview, IL: American Pain Society.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Brambilla F, Sacchetti E, Brunetta M. Pituitary-gonadal function in heroin addicts. Neuropsychobiology. 1977;3(2-3):160-6. doi: 10.1159/000117601.
- 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.
- 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.
- 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.
- Daniell HW. Narcotic-induced hypogonadism during therapy for heroin addiction. J Addict Dis. 2002;21(4):47-53. doi: 10.1300/J069v21n04_05.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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, 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.
- 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.
- 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.
- Khan C, Malik SA, Iqbal MA. Testosterone suppression by heroin. J Pak Med Assoc. 1990 Jul;40(7):172-3. No abstract available.
- 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.
- 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, 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, 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, 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, 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.
- 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.
- 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, 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.
- 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.
- Grossman A. Brain opiates and neuroendocrine function. Clin Endocrinol Metab. 1983 Nov;12(3):725-46. doi: 10.1016/s0300-595x(83)80062-0.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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, 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Anderson FH. Osteoporosis in men. Int J Clin Pract. 1998 Apr-May;52(3):176-80.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2006年10月30日
初级完成 (实际的)
2007年9月6日
研究完成 (实际的)
2007年9月6日
研究注册日期
首次提交
2006年11月8日
首先提交符合 QC 标准的
2006年11月8日
首次发布 (估计的)
2006年11月10日
研究记录更新
最后更新发布 (实际的)
2023年10月13日
上次提交的符合 QC 标准的更新
2023年10月11日
最后验证
2006年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
睾酮凝胶的临床试验
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Geneve TEAM AmbulancesUniversity Hospital, Geneva; ESAMB - College of Higher Education in Ambulance Care; Ambulances...完全的
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Seoul National University Hospital完全的