Si når: Målretting mot tung alkoholbruk med Naltrexone blant MSM (SayWhen)
18. april 2025 oppdatert av: University of California, San Francisco
Dette er en dobbeltblind, placebokontrollert studie av 120 overstadig drikking MSM til 12 uker med naltrekson 50 mg, som skal tas i påvente av tung drikking.
Etnisk og rasemessig mangfoldige deltakere vil bli rekruttert ved hjelp av Respondent Driven Sampling samt aktiv feltrekruttering.
MSM vil bli sett ukentlig for alkohol-metabolitt urintesting, utlevering av studiemedisiner og kort veiledning for alkoholbruk.
Sikkerhetsvurderinger og atferdsundersøkelser vil bli gjennomført månedlig.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
- Legemiddel: Placebo
- Atferdsmessig: Medisinsk ledelse (MM) rådgivning for alkoholbruk:
- Diagnostisk test: Urinalyse for nye alkoholbiokjemiske markører:
- Atferdsmessig: Målinger av atferdsundersøkelse:
- Diagnostisk test: Tørket blodflekk (DSB) testing for fosfatidyletanol
- Atferdsmessig: Økologisk øyeblikkelig vurdering
- Legemiddel: Naltrexone
Detaljert beskrivelse
Dette er en dobbeltblindet, placebokontrollert studie med 120 binge-drikkende MSM til 12 uker med Naltrexone 50 mg, som skal tas i påvente av kraftig drikking.
Etisk og rasemessige deltakere vil bli rekruttert ved hjelp av arenabasert rekruttering og sosiale nettverk BSED rekrutteringsstrategier.
Deltakerne vil bli sett ukentlig for alkoholmetabolitt urinprøving, studere medikamentdispensering og kort rådgivning for alkoholbruk.
Sikkerhetsvurderinger og atferdsundersøkelser vil være fullført månedlig.
Effektivitet på alkoholforbruk og alkoholassosiert seksuell risikoatferd (AIMS 1-3) vil bli vurdert ved bruk av ukentlig tidslinjefølging, screening for etylglukuronid (ETG) positive uriner og datamaskinadministrert månedlige intervensjoner.
Tolerabilitet og akseptabilitet (AIM 4) vil bli vurdert gjennom sporing av bivirkninger og medisiner.
Generaliserte estimeringsligningsmodeller (GEE) vil være tilpasset for å estimere behandlingseffekter på gjentatte studieutfall.
Studietype
Intervensjonell
Registrering (Faktiske)
120
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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San Francisco, California, Forente stater, 94102
- Center on Substance Use and Health
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Beskrivelse
Inklusjonskriterier:
- (1) Mannlig kjønn (2) selvrapportert analsex med menn i løpet av de tre foregående månedene mens de var påvirket av alkohol (3) minst én overstadig drikking (fem eller flere drinker ved en enkelt anledning) økt per uke i de foregående tre måneder; (4) interessert i å redusere overstadig alkoholforbruk; (5) HIV-negativ ved rask antistofftest eller journaldokumentasjon på HIV-infeksjon (HIV-positive deltakere); (6) ingen aktuelle akutte sykdommer som krever langvarig medisinsk behandling; (7) ingen kroniske sykdommer som sannsynligvis vil utvikle seg klinisk under forsøksdeltakelse; (8) i stand til og villig til å gi informert samtykke og overholde besøksplanen; (9) alder 18-70 år; (10) baseline CBC, totalt protein, albumin, glukose, alkalisk fosfatase, kreatinin, BUN og elektrolytter uten klinisk signifikante abnormiteter som bestemt av studieklinikeren i forbindelse med symptomer, fysisk undersøkelse og medisinsk historie.
Ekskluderingskriterier:
- (1) Enhver psykiatrisk (f.eks. depresjon med selvmordstanker) eller medisinsk tilstand som vil utelukke sikker deltakelse i studien; (2) kjent allergi/tidligere bivirkning mot naltrekson; (3) nåværende bruk av/avhengighet av opioider eller en kjent medisinsk tilstand som for tiden krever/kan sannsynligvis kreve opioidanalgetika; (4) opioid-positiv urin ved registrering; (5) nåværende CD4-tall < 200 celler/mm3 (6) moderat/alvorlig leversykdom (AST, ALAT > 3 ganger øvre normalgrense); (7) nedsatt nyrefunksjon (kreatininclearance < 50 ml/min); (8) deltar for tiden i en annen intervensjonsforskningsstudie med potensiell overlapping; (9) alkoholavhengighet bestemt av SCID-kriterier (deltakere med ikke-avhengige alkoholbruksforstyrrelser/symptomer på alkoholmisbruk [per DSM-IV] er kvalifisert) (10) enhver tilstand som, etter hovedetterforskeren og/eller studieklinikerens vurdering forstyrrer sikker studiedeltakelse eller overholdelse av studieprosedyrer; (11) ikke ha en mobiltelefon som kan sende og motta tekstmeldinger.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Placebo
Placebo 50 mg, etter behov
|
Placebo -kapsler vil inneholde mikrokrystallinsk cellulose (Medisca).
Placebo og aktiv medisiner vil bli gitt i kapsler som er en eksakt match i fargen, for å gjøre placebo og aktive medisiner som ikke kan skilles fra hverandre.
MM er et støttende program med lav intensitet designet for å øke problemgjenkjenning og forbedre motivasjonen for å endre maladaptiv alkoholbruksmønstre.
Deltakerne vil motta individuelle 20 minutters MM -økter ukentlig fra trent personale overvåket av en klinisk psykolog
Urinprøver vil bli samlet ukentlig og testet for etylglukuronid (ETG) for å bestemme nylig alkoholforbruk.
ETG er en relativt ny, svært følsom indikator for nylig alkoholforbruk; Denne alkoholbiomarkøren kan påvises i urin i omtrent 72 timer).
Andre navn:
Standardiserte og validerte atferdsmål som vil bli vurdert ved hjelp av lyddatamaskinadministrert undersøkelser (ACASI) for å minimere underrapportering av risikoaktiviteter og standardisere datainnsamling
Andre navn:
Fosfatidyletanol (PETH) -A fosfolipid dannet bare i nærvær av alkohol-er en ny, direkte biokjemisk markør for alkohol som har vist høy (> 95%) følsomhet og spesifisitet for å oppdage kraftig drikking over en periode på 2-3 uker i flere studier av avhengige pasienter og avholdende.
DSB-prøver blir samlet inn ved påmelding, uke 3, 6, 9, 12 og besøk etter behandling ved måned 1, 3 og 6.
Økologiske øyeblikkelige vurderinger er SMS -tekster for å samle inn data om alkoholforbruk, antall drinker på drikkedager og målrettet medisineringsadministrasjon før forventede drikkeøkter.
Meldinger vil bruke korthåndsnotasjoner for å opprettholde deltakerens konfidensialitet
|
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Aktiv komparator: Naltrekson
Naltrekson 50 mg, etter behov
|
MM er et støttende program med lav intensitet designet for å øke problemgjenkjenning og forbedre motivasjonen for å endre maladaptiv alkoholbruksmønstre.
Deltakerne vil motta individuelle 20 minutters MM -økter ukentlig fra trent personale overvåket av en klinisk psykolog
Urinprøver vil bli samlet ukentlig og testet for etylglukuronid (ETG) for å bestemme nylig alkoholforbruk.
ETG er en relativt ny, svært følsom indikator for nylig alkoholforbruk; Denne alkoholbiomarkøren kan påvises i urin i omtrent 72 timer).
Andre navn:
Standardiserte og validerte atferdsmål som vil bli vurdert ved hjelp av lyddatamaskinadministrert undersøkelser (ACASI) for å minimere underrapportering av risikoaktiviteter og standardisere datainnsamling
Andre navn:
Fosfatidyletanol (PETH) -A fosfolipid dannet bare i nærvær av alkohol-er en ny, direkte biokjemisk markør for alkohol som har vist høy (> 95%) følsomhet og spesifisitet for å oppdage kraftig drikking over en periode på 2-3 uker i flere studier av avhengige pasienter og avholdende.
DSB-prøver blir samlet inn ved påmelding, uke 3, 6, 9, 12 og besøk etter behandling ved måned 1, 3 og 6.
Økologiske øyeblikkelige vurderinger er SMS -tekster for å samle inn data om alkoholforbruk, antall drinker på drikkedager og målrettet medisineringsadministrasjon før forventede drikkeøkter.
Meldinger vil bruke korthåndsnotasjoner for å opprettholde deltakerens konfidensialitet
Revia er en hvit, krystallinsk forbindelse.
Hydrokloridsaltet er oppløselig i vann i den grad 100 mg/ml.
Revia er tilgjengelig i scorede filmbelagte tabletter som inneholder 50 mg naltrexon hydrochloride.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Overstadig drikkedager per uke
Tidsramme: 12 uker
|
Dette utfallsmålet bestemmer gjennomsnittlig antall overstadige drikkedager blant deltakere randomisert til målrettet naltrexon og placebo -armer.
Center for Disease Control (CDC) definerer overstadig drikking som konsumerer 5 eller flere drinker ved en anledning for menn eller 4 eller flere drinker ved en anledning for kvinner.
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12 uker
|
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Positive etylglukuronid (ETG) tester
Tidsramme: 12 uker
|
Dette utfallsmålet bestemmer antall deltakere med positive etylglukuronidtester blant ikke-avhengige MSM som ble randomisert til målrettet naltrexon og placebo-armer.
Etylglukuronid (ETG) er en ikke-flyktig, vannløselig, stabil, direkte metabolitt av etanol som kan oppdages i urin i 48 timer eller noen ganger 72 timer etter å ha drukket hvis det er kraftig drikking.
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12 uker
|
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Mannlige analsexpartnere
Tidsramme: 12 uker
|
Dette utfallsmålet bestemmer gjennomsnittlig antall mannlige analsexpartnere blant ikke-avhengige MSM randomisert til målrettet naltrexon og placebo-armer.
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12 uker
|
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Ubeskyttede analsexpartnere mens de er beruset av alkohol
Tidsramme: 12 uker
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Dette utfallsmålet bestemmer gjennomsnittlig antall ubeskyttede analsexpartnere mens de er beruset av alkohol blant målrettede naltrexon- og placebo -armer.
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12 uker
|
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HIV-serodiscordant ubeskyttede analsexpartnere
Tidsramme: 12 uker
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Dette utfallsmålet bestemmer gjennomsnittlig antall HIV-serodiscordante ubeskyttede analsexpartnere blant de målrettede naltrexon- og placebo-armer.
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12 uker
|
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Ubeskyttede analsexhendelser med serodiscordant partnere
Tidsramme: 12 uker
|
Dette utfallsmålet bestemmer gjennomsnittlig antall ubeskyttede analsexhendelser med serodiscordant partnere
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12 uker
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Glenn-Milo Santos, PhD, San Francisco Department of Public Health
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. april 2015
Primær fullføring (Faktiske)
1. januar 2021
Studiet fullført (Faktiske)
1. januar 2021
Datoer for studieregistrering
Først innsendt
30. desember 2014
Først innsendt som oppfylte QC-kriteriene
30. desember 2014
Først lagt ut (Antatt)
5. januar 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. april 2025
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. april 2025
Sist bekreftet
1. april 2025
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Stoffrelaterte lidelser
- Kjemisk-induserte lidelser
- Drikkeatferd
- Alkoholrelaterte lidelser
- Alkoholdrikking
- Overstadig drikking
- Anti-infeksjonsmidler
- Fysiologiske effekter av legemidler
- Agenter i det perifere nervesystemet
- Sentralnervesystemdepressiva
- Sensoriske systemagenter
- Alkoholavskrekkende midler
- Anti-infeksjonsmidler, lokale
- Narkotiske antagonister
- Etanol
- Naltrekson
Andre studie-ID-numre
- 1DP5OD019809 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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