Analgetisk effekt af testosteronerstatning hos hypogonadale opioidbehandlede kroniske smertepatienter: en pilotundersøgelse.
11. oktober 2023 opdateret af: Chris Cardozo, James J. Peters Veterans Affairs Medical Center
Formålet med dette pilotstudie er at teste virkningerne af testosteronerstatning på smerter, træthed, humør, kognition og libido hos hypogonadale mænd på langvarig opioidbehandling for kroniske smerter.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Opioider bruges i stigende grad til behandling af ikke-maligne kroniske smerter med så mange som fem til ti millioner patienter behandlet på tidspunktet for det seneste skøn i 2002.
Bivirkningerne af opioider såsom træthed, tab af libido, nedsat kognition og seksuel dysfunktion har længe været genkendt og ligner påfaldende symptomer på hypogonadisme hos mænd.
Mange undersøgelser har vist en høj forekomst af hypogonadisme hos mandlige forsøgspersoner, som er langtidsbrugere af opioider.
Formålet med dette pilotstudie er, hos hypogonadale mænd, der behandles med opioider for kroniske smerter, at: 1) bestemme effekten af TRT på smerte; 2) bestemme virkningerne af TRT på træthed; 3) bestemme virkningen af TRT på humør; 4) bestemme virkningerne af TRT på kognition og 5) karakterisere virkningerne af TRT på seksuel dysfunktion.
Dette studie er et randomiseret, placebokontrolleret, 6-ugers pilotstudie.
Undersøgelsestype
Interventionel
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: David AN Siegel, M.D.
- Telefonnummer: 212-433-0606
- E-mail: david.siegel2@med.va.gov
Studiesteder
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New York
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Bronx, New York, Forenede Stater, 10468
- Rekruttering
- James J. Peters VAMC
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Kontakt:
- David AN Siegel, M.D.
- Telefonnummer: 212-433-0606
- E-mail: david.siegel2@med.va.gov
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Ledende efterforsker:
- David AN Siegel, M.D.
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Underforsker:
- Christopher Cardoza, M.D.
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Underforsker:
- William Bauman, M.D.
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Underforsker:
- Ann Spungen, Ed.D
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Voksne mandlige patienter (over 18 år og under 60 år)
- Modtagelse af mere end 20 IV morfinækvivalenter/dag med <20 % ændring i dosis inden for den sidste måned.
- AM total testosteron <300 ng/dL
- Rapporter "værste smerter i den seneste uge" rivejern end 4 på en 11-punkts numerisk skala.
Ekskluderingskriterier:
- Kvinder
- Dårligt kontrollerede, symptomatiske, aktive medicinske eller psykiatriske problemer (f.eks. HIV, hepatitis, diabetes, kræft, godartet prostatahypertrofi, stofmisbrug, svær depression)
- Neurologisk eller psykiatrisk lidelse, der ville kompromittere patientens evne til at give informeret samtykke eller overholde kravene i protokollen.
- Anamnese med prostatacancer, unormale fund ved digital rektalundersøgelse eller PSA større end 4,0 ng/m
- Historie om polycytæmi
- Nyre- eller leverdysfunktion
- Hæmatokrit >55 %
- Kendt historie med overfølsomhed over for transdermal testosterongel.
- Abnormiteter under digital rektalundersøgelse.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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• For at afgøre, om testosteronerstatning kan forbedre smertekontrol hos opioidbehandlede, hypogonadale mænd med kroniske smerter.
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Sekundære resultatmål
Resultatmål |
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Hos opioidbehandlede, hypogonadale mænd med kroniske smerter, for at afgøre, om testosteronsubstitutionsterapi (TRT) vil:
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reducere opioidbehovet.
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forbedre træthed
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forbedre depression
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forbedre den seksuelle funktion.
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Forbedre kognition
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For at bestemme andelen af respondere på de analgetiske virkninger af TRT
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Christopher P Cardozo, M.D., James J. Peters VAMC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- 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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- 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.
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- 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.
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- 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.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. oktober 2006
Primær færdiggørelse (Faktiske)
6. september 2007
Studieafslutning (Faktiske)
6. september 2007
Datoer for studieregistrering
Først indsendt
8. november 2006
Først indsendt, der opfyldte QC-kriterier
8. november 2006
Først opslået (Anslået)
10. november 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. oktober 2023
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. oktober 2023
Sidst verificeret
1. november 2006
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2192-06-049
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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