- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02330419
Sig hvornår: Målretning af tungt alkoholforbrug med Naltrexon blandt MSM (SayWhen)
18. april 2025 opdateret af: University of California, San Francisco
Dette er et dobbeltblindt, placebo-kontrolleret forsøg med 120 binge-drinking MSM til 12 ugers naltrexon 50mg, der skal tages i forventning om kraftigt drikkeri.
Etnisk og racemæssigt forskelligartede deltagere vil blive rekrutteret ved hjælp af Respondent Driven Sampling samt aktiv feltrekruttering.
MSM vil blive set ugentligt til alkohol-metabolit-urintestning, udlevering af studiemedicin og kort rådgivning om alkoholbrug.
Sikkerhedsvurderinger og adfærdsundersøgelser vil blive gennemført hver måned.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
- Medicin: Placebo
- Adfærdsmæssigt: Medicinsk styring (MM) rådgivning til alkoholbrug:
- Diagnostisk test: Urinalyse til nye alkoholbiokemiske markører:
- Adfærdsmæssigt: Målinger af adfærdsundersøgelser:
- Diagnostisk test: Tørret blodplads (DSB) -test til phosphatidylethanol
- Adfærdsmæssigt: Økologisk øjeblikkelig vurdering
- Medicin: Naltrexon
Detaljeret beskrivelse
Dette er et dobbeltblindet, placebo-kontrolleret forsøg med 120 binge-drinking MSM til 12 ugers naltrexon 50 mg, der skal tages i forventning om kraftig drikning.
Etisk og racemæssigt forskellige deltagere vil blive rekrutteret ved hjælp af spillebaseret rekruttering og BSED -rekrutteringsstrategier for socialt netværk.
Deltagerne ses ugentligt for alkoholmetabolit urinprøvning, undersøgelsesmedicinsk dispensering og kort rådgivning til alkoholbrug.
Sikkerhedsvurderinger og adfærdsundersøgelser afsluttes månedligt.
Effektivitet på alkoholforbrug og alkoholassocieret seksuel risikoadfærd (AIMS 1-3) vurderes ved hjælp af ugentlig opfølgning af tidslinjen, screening for ethylglucuronid (ETG) positive uriner og computeradministreret månedlige interventioner.
Tolerabilitet og acceptabilitet (AIM 4) vurderes gennem sporing af bivirkninger og medicinsk adhæsion.
Generaliserede estimering af ligning (GEE) modeller vil være monteret til at estimere behandlingseffekter på gentagne undersøgelsesresultater.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
120
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
San Francisco, California, Forenede Stater, 94102
- Center on Substance Use and Health
-
-
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 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- (1) Mandligt køn (2) selvrapporteret analsex med mænd i de foregående tre måneder, mens de var påvirket af alkohol (3) mindst én overstadig alkoholsession (fem eller flere drinks ved en enkelt lejlighed) om ugen i de foregående tre måneder; (4) interesseret i at reducere binge alkoholforbrug; (5) HIV-negativ ved hurtig antistoftest eller journaldokumentation for HIV-infektion (HIV-positive deltagere); (6) ingen aktuelle akutte sygdomme, der kræver længerevarende lægebehandling; (7) ingen kroniske sygdomme, der sandsynligvis vil udvikle sig klinisk under forsøgsdeltagelse; (8) i stand til og villig til at give informeret samtykke og overholde besøgsplanen; (9) alder 18-70 år; (10) baseline CBC, totalt protein, albumin, glucose, alkalisk fosfatase, kreatinin, BUN og elektrolytter uden klinisk signifikante abnormiteter som bestemt af undersøgelsesklinikeren i forbindelse med symptomer, fysisk undersøgelse og sygehistorie.
Ekskluderingskriterier:
- (1) Enhver psykiatrisk (f.eks. depression med selvmordstanker) eller medicinsk tilstand, der ville udelukke sikker deltagelse i undersøgelsen; (2) kendt allergi/tidligere bivirkning over for naltrexon; (3) aktuel brug af/afhængighed af opioider eller en kendt medicinsk tilstand, som i øjeblikket kræver/kan kræve opioidanalgetika; (4) opioid-positiv urin ved indskrivning; (5) nuværende CD4-tal < 200 celler/mm3 (6) moderat/alvorlig leversygdom (AST, ALAT > 3 gange øvre normalgrænse); (7) nedsat nyrefunktion (kreatininclearance < 50 ml/min); (8) deltager i øjeblikket i en anden interventionsforskningsundersøgelse med potentiel overlapning; (9) alkoholafhængighed som bestemt af SCID-kriterier (deltagere med ikke-afhængige alkoholmisbrugsforstyrrelser/symptomer på alkoholmisbrug [pr. DSM-IV] er berettigede) (10) enhver tilstand, som efter hovedforskeren og/eller undersøgelsesklinikerens vurdering forstyrrer sikker undersøgelsesdeltagelse eller overholdelse af undersøgelsesprocedurer; (11) ikke at have en mobiltelefon, der kan sende og modtage tekstbeskeder.
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: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Placebo 50 mg efter behov
|
Placebo -kapsler vil indeholde mikrokrystallinsk cellulose (Medisca).
Placebo og aktiv medicin leveres i kapsler, der er en nøjagtig match i farve, for at gøre placebo og aktiv medicin, der ikke kan skelnes fra hinanden.
MM er et støttende program med lav intensitet designet til at øge problemgenkendelse og forbedre motivationen til at ændre maladaptive alkoholbrugsmønstre.
Deltagerne modtager individuelle 20 minutters mm -sessioner ugentligt fra uddannet personale, der er overvåget af en klinisk psykolog
Urinprøver opsamles ugentligt og testes for ethylglucuronid (ETG) for at bestemme det nylige alkoholforbrug.
ETG er en relativt ny, meget følsom indikator for det nylige alkoholforbrug; Denne alkoholbiomarkør kan påvises i urin i cirka 72 timer).
Andre navne:
Standardiserede og validerede adfærdsmæssige mål, der vil blive vurderet ved hjælp af lydcomputeradministrerede undersøgelser (ACASI) for at minimere underrapportering af risikoaktiviteter og standardisere dataindsamling
Andre navne:
Phosphatidylethanol (Peth) -en phospholipid dannet kun i nærvær af alkohol-er en ny, direkte biokemisk markør for alkohol, der har vist høj (> 95%) følsomhed og specificitet til at detektere kraftig drikning over en periode på 2-3 uger i flere undersøgelser af afhængige patienter og abstainers.
DSB-prøver indsamles ved tilmelding, uger 3, 6, 9, 12 og efterbehandlingsbesøg i måned 1, 3 og 6.
Økologiske øjeblikkelige vurderinger er SMS -tekster til at indsamle data om alkoholforbrug, antal drinks på drikkedage og målrettet medicinadministration inden forventede drikke sessioner.
Meddelelser bruger korthåndsnotationer til at bevare deltagerens fortrolighed
|
|
Aktiv komparator: Naltrexon
Naltrexon 50mg efter behov
|
MM er et støttende program med lav intensitet designet til at øge problemgenkendelse og forbedre motivationen til at ændre maladaptive alkoholbrugsmønstre.
Deltagerne modtager individuelle 20 minutters mm -sessioner ugentligt fra uddannet personale, der er overvåget af en klinisk psykolog
Urinprøver opsamles ugentligt og testes for ethylglucuronid (ETG) for at bestemme det nylige alkoholforbrug.
ETG er en relativt ny, meget følsom indikator for det nylige alkoholforbrug; Denne alkoholbiomarkør kan påvises i urin i cirka 72 timer).
Andre navne:
Standardiserede og validerede adfærdsmæssige mål, der vil blive vurderet ved hjælp af lydcomputeradministrerede undersøgelser (ACASI) for at minimere underrapportering af risikoaktiviteter og standardisere dataindsamling
Andre navne:
Phosphatidylethanol (Peth) -en phospholipid dannet kun i nærvær af alkohol-er en ny, direkte biokemisk markør for alkohol, der har vist høj (> 95%) følsomhed og specificitet til at detektere kraftig drikning over en periode på 2-3 uger i flere undersøgelser af afhængige patienter og abstainers.
DSB-prøver indsamles ved tilmelding, uger 3, 6, 9, 12 og efterbehandlingsbesøg i måned 1, 3 og 6.
Økologiske øjeblikkelige vurderinger er SMS -tekster til at indsamle data om alkoholforbrug, antal drinks på drikkedage og målrettet medicinadministration inden forventede drikke sessioner.
Meddelelser bruger korthåndsnotationer til at bevare deltagerens fortrolighed
Revia er en hvid, krystallinsk forbindelse.
Hydrochloridsalt er opløseligt i vand i størrelsesordenen ca. 100 mg/ml.
Revia fås i scorede filmovertrukne tabletter indeholdende 50 mg naltrexonhydrochlorid.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Binge drikkedage om ugen
Tidsramme: 12 uger
|
Dette resultatmål bestemmer det gennemsnitlige antal overstadige drikkedage blandt deltagerne, der er randomiseret til målrettet naltrexon og placebo -arme.
Center for Disease Control (CDC) definerer overstadig drikke som konsumerende 5 eller flere drinks ved en lejlighed til mænd eller 4 eller flere drinks ved en lejlighed for kvinder.
|
12 uger
|
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Positive ethylglucuronid (ETG) -test
Tidsramme: 12 uger
|
Dette resultatmål bestemmer antallet af deltagere med positive ethylglucuronidforsøg blandt ikke-afhængige MSM, der blev randomiseret til målrettet naltrexon og placebo-arme.
Ethylglucuronid (ETG) er en ikke-flygtig, vandopløselig, stabil, direkte metabolit af ethanol, der kan detekteres i urin i 48 timer eller undertiden 72 timer efter at have drukket, hvis der er kraftig drikning.
|
12 uger
|
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Mandlige analsexpartnere
Tidsramme: 12 uger
|
Dette resultatmål bestemmer det gennemsnitlige antal mandlige analsexpartnere blandt ikke-afhængige MSM randomiseret til målrettet naltrexon og placebo-arme.
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12 uger
|
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Ubeskyttede analsexpartnere, mens de er beruset med alkohol
Tidsramme: 12 uger
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Dette resultatmål bestemmer det gennemsnitlige antal ubeskyttede analsexpartnere, mens de er beruset med alkohol blandt målrettede naltrexon- og placebo -arme.
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12 uger
|
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HIV-serodiscordant ubeskyttede analsexpartnere
Tidsramme: 12 uger
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Dette resultatmål bestemmer det gennemsnitlige antal HIV-serodiscordante ubeskyttede analsexpartnere blandt de målrettede naltrexon- og placebo-arme.
|
12 uger
|
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Ubeskyttede analsexbegivenheder med serodiscordante partnere
Tidsramme: 12 uger
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Dette resultatmål bestemmer det gennemsnitlige antal ubeskyttede analsexbegivenheder med serodiscordante partnere
|
12 uger
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Glenn-Milo Santos, PhD, San Francisco Department of Public Health
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.
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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)
1. april 2015
Primær færdiggørelse (Faktiske)
1. januar 2021
Studieafslutning (Faktiske)
1. januar 2021
Datoer for studieregistrering
Først indsendt
30. december 2014
Først indsendt, der opfyldte QC-kriterier
30. december 2014
Først opslået (Anslået)
5. januar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. april 2025
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. april 2025
Sidst verificeret
1. april 2025
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Stof-relaterede lidelser
- Kemisk inducerede lidelser
- Drikkeadfærd
- Alkohol-relaterede lidelser
- Alkohol drikke
- Druk
- Anti-infektionsmidler
- Lægemidlers fysiologiske virkninger
- Agenter fra det perifere nervesystem
- Centralnervesystemdepressiva
- Sensoriske systemagenter
- Alkoholafskrækkende midler
- Anti-infektionsmidler, lokale
- Narkotiske antagonister
- Ethanol
- Naltrexon
Andre undersøgelses-id-numre
- 1DP5OD019809 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
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