Acceptabilitets- og Gennemførlighedsundersøgelse af Alkoholfrie Drikkevarer
17. juli 2026 opdateret af: Molly Anne Bowdring, Stanford University
Ikke-alkoholiske drikkevarer som terapeutisk supplement i behandling af alkoholbrugsforstyrrelse: et pilotstudie af acceptabilitet og gennemførlighed
Dette projekt vil belyse acceptabiliteten og gennemførligheden af at inkorporere udbud af alkoholfri øl i behandlingen af alkoholforstyrrelse for patienter, der er interesserede i at bruge alkoholfri øl som en del af deres rekonvalescens fra alkoholforstyrrelse.
Studieoversigt
Status
Tilmelding efter invitation
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Stanford, California, Forenede Stater, 94304
- Stanford Prevention Research Center
-
-
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
Deltagere vil være kvalificerede, hvis de angiver i screeningsundersøgelsen:
- at bo i Californien og oplyser en californisk postadresse (til levering af studiematerialer)
- at indtage ≤42 alkoholiske drikkevarer om ugen (da vi ønsker at give et lige antal erstatningsdrikkevarer, og budgetmæssige begrænsninger forhindrer et større antal)
- at have dokumenteret alkoholmisbrug med ≥2 symptomer på Alkohol Symptom Checklist
- at være tilmeldt Ria Health-behandling
- at have flydende engelskkundskaber
Eksklusionskriterier:
- Personer vil blive udelukket på online screeningsundersøgelsestrinet, hvis de ikke opfylder alle inklusionskriterierne.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Alkoholfri øl
Deltagerne vil modtage alkoholfrie øl (mængde svarende til alkoholindtaget før behandling for alkoholmisbrug) i 6 uger.
|
Deltagerne vil modtage alkoholfrie øl og vil blive opfordret til at indtage drikkevarerne i det omfang, de finder nyttigt/ønskeligt i løbet af den 6-ugers undersøgelsesperiode.
|
|
Andet: Danskvand
Deltagerne vil modtage brusende vand (volumen svarende til alkoholindtaget før optagelse i behandling for alkoholforbrugssygdom) i 6 uger.
|
Deltagerne vil modtage mousserende vand og vil blive opfordret til at indtage drikkevarerne i det omfang, de finder nyttigt/ønskeligt i løbet af den 6-ugers undersøgelsesperiode.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Participant Beverage Satisfaction (Acceptability)
Tidsramme: Assessed at the end of week 6
|
"How satisfied were you with the beverages you received in this study?"
with 5-pt scale response options ranging from "Very Unsatisfied" to "Very Satisfied."
Higher scores [split by condition] will indicate greater acceptability.
|
Assessed at the end of week 6
|
|
Participant Intention to Consume Assigned Beverage in the Future (Acceptability)
Tidsramme: Assessed at the end of week 6
|
"Do you intend to consume the beverage type you received in the future?" with 5-pt scale response options ranging from "Definitely not" to "Definitely."
Higher scores [split by condition] will indicate greater acceptability.
|
Assessed at the end of week 6
|
|
Participant Likelihood of Recommending Beverage (Acceptability)
Tidsramme: Assessed at the end of week 6
|
"Would you recommend the use of the beverage type you received for people who have alcohol use disorder?"
with 5-pt scale response options ranging from "Definitely not" to "Definitely."
Higher scores [split by condition] will indicate greater acceptability.
|
Assessed at the end of week 6
|
|
Screened Out of Contacted (Feasibility)
Tidsramme: Beginning of recruitment to end of recruitment (approximately 3-6 months)
|
Percentage of participants who completed the screening measure out of those who were contacted.
Higher percentage will indicate greater feasibility.
|
Beginning of recruitment to end of recruitment (approximately 3-6 months)
|
|
Eligible Out of Screened (Feasibility)
Tidsramme: Beginning of recruitment to end of recruitment (approximately 3-6 months)
|
Percentage of participants who screen eligible out of those who were screened.
Higher percentage will indicate greater feasibility.
|
Beginning of recruitment to end of recruitment (approximately 3-6 months)
|
|
Enrolled Out of Eligible (Feasibility)
Tidsramme: Beginning of recruitment to end of recruitment (approximately 3-6 months)
|
Percentage of participants who enrolled out of those who screened eligible.
Higher percentage will indicate greater feasibility.
|
Beginning of recruitment to end of recruitment (approximately 3-6 months)
|
|
Retention (Feasibility)
Tidsramme: Beginning of recruitment to end of data collection (approximately 3-6 months)
|
Percentage of participants who completed the study out of those who enrolled.
Higher percentage [split by condition] will indicate greater feasibility.
|
Beginning of recruitment to end of data collection (approximately 3-6 months)
|
|
Perception of Beverage Supply (Feasibility)
Tidsramme: Assessed at the end of week 6
|
Percentage of participants whose response to "How was the supply of beverages you received throughout the study?" is "just right" [as opposed to "too little" or "too much"].
Higher percentage [split by condition] will indicate greater feasibility.
|
Assessed at the end of week 6
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Average Blood Alcohol Content Across 6 Weeks
Tidsramme: Study weeks 1-6
|
Average blood alcohol content (measured via breathalyzer) across the 6-week period split by condition.
|
Study weeks 1-6
|
|
Change in Blood Alcohol Content Across 6 Weeks
Tidsramme: Treatment entry to week 6
|
Slopes of blood alcohol content separated by condition for: a) start of treatment to pre-study and b) during the 6-week study period [split by condition].
|
Treatment entry to week 6
|
|
Average Number of Days with Breathalyzer Readings
Tidsramme: Assessed at 6 weeks.
|
Average number of days with breathalyzer readings across the 6-week study.
|
Assessed at 6 weeks.
|
|
Median Number of Breathalyzer Readings Among Days with Readings
Tidsramme: Assessed at 6 weeks.
|
Median number of breathalyzer readings among days with readings across the 6-week study.
|
Assessed at 6 weeks.
|
|
Change in Reported Alcohol Use
Tidsramme: Baseline to 6 weeks.
|
Percentage of participants endorsing use of study-provided beverages who experienced (a) increase in alcohol use (defined as change in average use per week pre-study to average use per week across the study), (b) no change in alcohol use, (c) decrease in alcohol use [split by condition].
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Baseline to 6 weeks.
|
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Perceived Change in Craving
Tidsramme: Assessed at 6 weeks.
|
Percentage of participants endorsing use of study-provided beverages who reported (a) increased in desire to drink alcohol, (b) no change in desire to drink alcohol, (c) decreased desire to drink alcohol [split by condition] in response to the item "When I drink the study provided beverages I experience…Less desire to drink alcohol; No change in my desire to drink alcohol; or More desire to drink alcohol.
|
Assessed at 6 weeks.
|
|
Perceived Change in Alcohol Use
Tidsramme: Assessed at 6 weeks.
|
Percentage of participants endorsing use of study-provided beverages who reported (a) increased in alcohol use, (b) no change in alcohol use, (c) increased alcohol use [split by condition] in response to the item "Because I drink the study provided beverages I drink...Less alcohol than I otherwise would; The same amount of alcohol that I otherwise would; or More alcohol than I otherwise would."
|
Assessed at 6 weeks.
|
|
Perceived Impact of Beverages on Recovery
Tidsramme: Assessed at 6 weeks.
|
Percentage of participants who responded to the item "What impact did the study provided beverages have on your recovery from alcohol use disorder?"
with (a) Harmful; (b) No impact; or (c) Helpful [split by condition].
|
Assessed at 6 weeks.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Molly A Bowdring, PhD, Stanford University
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)
14. maj 2026
Primær færdiggørelse (Anslået)
1. oktober 2026
Studieafslutning (Anslået)
1. november 2026
Datoer for studieregistrering
Først indsendt
27. februar 2026
Først indsendt, der opfyldte QC-kriterier
27. februar 2026
Først opslået (Faktiske)
5. marts 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Stof-relaterede lidelser
- Kemisk inducerede lidelser
- Alkohol-relaterede lidelser
- Alkoholisme
- Diæt, mad og ernæring
- Fysiologiske fænomener
- Mad og drikkevarer
- Uorganiske kemikalier
- Drikkevarer
- Anioner
- Ioner
- Elektrolytter
- Hydroxider
- Alkalier
- Oxider
- Oxygenforbindelser
- Vand
- Mineralvand
- Kulsyreholdige Drikkevarer
- Drikkevand
- Kulsyreholdigt vand
Andre undersøgelses-id-numre
- 83997
- 1K99AA031716 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Data vil blive uploadet til NIAAA-dataarkivet
IPD-delingstidsramme
Analytisk kode, data og dataordbog vil blive uploadet på tidspunktet for indsendelse af primære resultater til et akademisk tidsskrift.
IPD-deling Understøttende informationstype
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 .