Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

Официальное название

Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism

Обзор

The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, fatigue, and quality of life when compared with placebo in men with chronic spinal pain treated with opioids who have opioid-induced hypogonadism (low testosterone).

Подробное описание

This single-center, randomized, double-blind, placebo-controlled, parallel-group trial will evaluate pain and quality of life outcomes associated with 6 months of treatment with testosterone or placebo in men aged 18 years or older with chronic non-cancer spinal pain who are taking opioid analgesics for at least 6 months and have opioid-induced hypogonadism.

Вмешательства

• Препарат Testosterone Undecanoate 250 MG/ML
  Intramuscular administration at a dose of 750 mg at baseline, weeks 4, and week 14.
• Препарат Placebo
  Intramuscular administration of placebo at baseline, weeks 4, and week 14.

Первичные конечные точки

• Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire [Срок оценки: Baseline, 3 months, and 6 months]

Вторичные конечные точки (6)

• Changes in response to quantitative sensory testing of pain under pressure stimulus [Срок оценки: Baseline, 3 months, and 6 months]
• Changes in response to quantitative sensory testing of pain under deep pressure stimulus [Срок оценки: Baseline, 3 months, and 6 months]
• Changes in response to quantitative sensory testing of pain under a mechanical stimulus [Срок оценки: Baseline, 3 months, and 6 months]
• Changes in response to quantitative sensory testing of pain under heat stimulus [Срок оценки: Baseline, 3 months, and 6 months]
• Changes in response to quantitative sensory testing of pain under cold stimulus [Срок оценки: Baseline, 3 months, and 6 months]
• Changes in default mode network connectivity [Срок оценки: Baseline and 6 months]

Критерии участия

Критерии включения

• Men, age 18 years and older.
• Chronic non-cancer spinal pain.
• Use of opioid analgesics for at least 6 months.
• Serum total testosterone (measured by mass spectrometry) <348 ng/dL and/or free testosterone <70 pg/mL.
• Ability and willingness to provide informed consent.

Критерии исключения

• History of prostate cancer or breast cancer.
• Known history of organic hypogonadism (e.g., due to hypothalamic, pituitary or testicular disease).
• Use of testosterone within the past 6 months.
• Baseline hematocrit >48%.
• Prostate-specific antigen (PSA) level >4 ng/mL in Caucasians or >3 ng/mL in African-Americans.
• Presence of prostate nodule or induration on digital rectal examination.
• Uncontrolled congestive heart failure.
• Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 3 months.
• Serum creatinine >2.5 mg/dL.
• Alanine aminotransferase (ALT) level 3 times above the upper limit of normal.
• Diagnosis of bipolar disorder or schizophrenia.
• Presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the patient from undergoing functional magnetic resonance imaging (MRI). In subjects who are otherwise eligible and either do not qualify for MRI or are reluctant to undergo imaging, the investigators may consider enrolling such participants on a case-by-case basis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Boston

Публикации

• Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559. PMID 25581257
• Von Korff M, Kolodny A, Deyo RA, Chou R. Long-term opioid therapy reconsidered. Ann Intern Med. 2011 Sep 6;155(5):325-8. doi: 10.7326/0003-4819-155-5-201109060-00011. PMID 21893626
• Aloisi AM, Ceccarelli I, Fiorenzani P. Gonadectomy affects hormonal and behavioral responses to repetitive nociceptive stimulation in male rats. Ann N Y Acad Sci. 2003 Dec;1007:232-7. doi: 10.1196/annals.1286.022. PMID 14993056
• Fillingim RB, Edwards RR, Powell T. The relationship of sex and clinical pain to experimental pain responses. Pain. 1999 Dec;83(3):419-425. doi: 10.1016/S0304-3959(99)00128-1. PMID 10568849
• Basaria S. Male hypogonadism. Lancet. 2014 Apr 5;383(9924):1250-63. doi: 10.1016/S0140-6736(13)61126-5. Epub 2013 Oct 10. PMID 24119423
• Fillingim RB, Edwards RR. The association of hormone replacement therapy with experimental pain responses in postmenopausal women. Pain. 2001 May;92(1-2):229-34. doi: 10.1016/s0304-3959(01)00256-1. PMID 11323144
• Daniell HW. Hypogonadism in men consuming sustained-action oral opioids. J Pain. 2002 Oct;3(5):377-84. doi: 10.1054/jpai.2002.126790. PMID 14622741
• Rajagopal A, Vassilopoulou-Sellin R, Palmer JL, Kaur G, Bruera E. Symptomatic hypogonadism in male survivors of cancer with chronic exposure to opioids. Cancer. 2004 Feb 15;100(4):851-8. doi: 10.1002/cncr.20028. PMID 14770444

Идентификаторы

NCT: NCT04798469 · 2021P000331

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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