Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-29 @ 4:20 AM
Study NCT ID:
NCT00398034
Status:
WITHDRAWN
Last Update Posted:
2023-10-13
First Post:
2006-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The original PI (David Siegel) Left the VA', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2007-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-11', 'studyFirstSubmitDate': '2006-11-08', 'studyFirstSubmitQcDate': '2006-11-08', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• To determine if testosterone replacement can improve pain control in opioid-treated, hypogonadal men with chronic pain.'}], 'secondaryOutcomes': [{'measure': 'In opioid-treated, hypogonadal men with chronic pain, to determine whether testosterone replacement therapy (TRT) will:'}, {'measure': 'reduce the opioid requirement.'}, {'measure': 'improve fatigue'}, {'measure': 'improve depression'}, {'measure': 'improve sexual function.'}, {'measure': 'Improve cognition'}, {'measure': 'To determine the proportion of responders to the analgesic effects of TRT'}]}, 'conditionsModule': {'keywords': ['opioids', 'pain', 'hypogonadism', 'depression', 'fatigue', 'cognition', 'libido'], 'conditions': ['Pain', 'Hypogonadism']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'American Pain Society, Guidelines for the Management of Acute and Cancer Pain. 4 ed. 1999, Glenview, IL: American Pain Society.'}, {'pmid': '8869456', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '14609780', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8249554', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '6798601', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1117911', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '640760', 'type': 'BACKGROUND', 'citation': 'Crowley TJ, Simpson R. Methadone dose and human sexual behavior. Int J Addict. 1978 Feb;13(2):285-95. doi: 10.3109/10826087809039281.'}, {'pmid': '4503902', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '4474860', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '7119946', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '4747447', 'type': 'BACKGROUND', 'citation': '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. 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Cogn Affect Behav Neurosci. 2001 Dec;1(4):371-81. doi: 10.3758/cabn.1.4.371.'}, {'pmid': '12791435', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Opioids are increasingly used for the treatment of non-malignant chronic pain with as many as five to ten million patients treated at the time of the most recent estimate in 2002. The side effects of opioids such as fatigue, loss of libido, Impaired cognition and sexual dysfunction have long been recognize and strikingly, resemble symptoms of hypogonadism in men. Many studies have demonstrated a high prevalence of hypogonadism in male subjects who are long-term users of opioids. The aims of this pilot study are, in hypogonadal men being treated with opioids for chronic pain, to: 1) determine the effect of TRT on pain; 2) determine effects of TRT on fatigue; 3) determine the effect of TRT on mood; 4) determine effects of TRT on cognition and 5) characterize the effects of TRT on sexual dysfunction. This study is a randomized, placebo-controlled, 6-week pilot study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male patients (above 18 years old and below 60 years old)\n* Receiving greater than 20 IV morphine equivalents/day with \\<20% change in dosage in the last month.\n* AM total testosterone \\<300 ng/dL\n* Report "worst pain during the past week" grater than 4 on an 11-point numeric scale.\n\nExclusion Criteria:\n\n* Females\n* Poorly controlled, symptomatic, active medical or psychiatric problems (e.g., HIV, hepatitis, diabetes, cancer, benign prostatic hypertrophy, substance abuse, major depression)\n* Neurological or psychiatric disorder that would compromise the patient\'s ability to give informed consent or adhere to the requirements of the protocol.\n* History of prostate cancer, abnormal findings on digital rectal exam, or PSA greater than 4.0 ng/m\n* History of polycythemia\n* Renal or hepatic dysfunction\n* Hematocrit \\>55%\n* Known history of hypersensitivity to transdermal testosterone gel.\n* Abnormalities during digital rectal exam.'}, 'identificationModule': {'nctId': 'NCT00398034', 'briefTitle': 'Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.', 'organization': {'class': 'FED', 'fullName': 'James J. Peters Veterans Affairs Medical Center'}, 'officialTitle': 'Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.', 'orgStudyIdInfo': {'id': '2192-06-049'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Testosterone Gel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christopher P Cardozo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'James J. Peters VAMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'James J. Peters Veterans Affairs Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Physician', 'investigatorFullName': 'Chris Cardozo', 'investigatorAffiliation': 'James J. Peters Veterans Affairs Medical Center'}}}}