- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02986776
Treatment Settings for Those With an Alcohol Problem
8. oktober 2020 opdateret af: Robert Rychtarik, State University of New York at Buffalo
Treatment Settings for Alcoholics: A Field Extension
A prior study in a tightly controlled clinical research environment found individuals with an alcohol use disorder (AUD) benefited more from inpatient (IP) than outpatient (OP) care, if they presented with high alcohol involvement and/or low cognitive functioning.
This study sought to: (a) validate and extend these findings within the uncontrolled environment of a community-based treatment center, and (b) test whether inpatients had fewer days of involuntary abstinence (e.g., incarcerations) relative to outpatients.
Based on their need for inpatient treatment, using prior cut-points for alcohol involvement and cognitive functioning, participants were randomly assigned within inpatient need group (No Need for IP; Needs IP) to either 21-days of inpatient substance misuse treatment or 21-days of outpatient treatment, all followed by 6 months of continuing outpatient care.
Follow-up were conducted an 90-day intervals across 18 months.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
176
Fase
- Ikke anvendelig
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Eligible for treatment through the Chemical Dependency treatment programs of a large, community-based healthcare network
- Drank alcoholic beverages within the last 90 days
- Have a current address (not homeless)
- Free of legal stipulations that would affect treatment decisions
- Have a past 3 months Alcohol Use Disorder
- Primary alcohol, or alcohol and drug problem
Exclusion Criteria:
- Homeless
- Drug problem only
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Inpatient Care + Needs Inpatient
Individuals with high alcohol involvement or low cognitive functioning receiving inpatient treatment
|
21 days of inpatient substance misuse treatment
|
|
Aktiv komparator: Inpatient Care + No Need for Inpatient
Individuals with low alcohol involvement or mid-high cognitive functioning receiving inpatient treatment
|
21 days of inpatient substance misuse treatment
|
|
Aktiv komparator: Outpatient Care + Needs Inpatient
Individuals with high alcohol involvement or low cognitive functioning receiving outpatient treatment
|
21 days of outpatient substance misuse treatment
|
|
Aktiv komparator: Outpatient Care + No Need for Inpatient
Individuals with low alcohol involvement and or mid-high cognitive functioning receiving outpatient treatment
|
21 days of outpatient substance misuse treatment
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Monthly Percentage of Voluntary Abstinent Days (from Timeline Followback Interview)
Tidsramme: Change up to 18 months
|
Percentage of Days Abstinent of those in which drinking was not restricted
|
Change up to 18 months
|
|
Monthly Point Prevalence of Abstinent Days (from Timeline Followback Interview)
Tidsramme: Change up to 18 months
|
Monthly percentage of participants abstinent throughout a month
|
Change up to 18 months
|
|
Monthly Drinks per Drinking Day (from Timeline Followback Interview)
Tidsramme: Change up to 18 months
|
For those drinking in a month, average drinks per drinking day
|
Change up to 18 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Monthly percentage of Involuntary abstinent days (from Timeline Followback Interview)
Tidsramme: Up to 18 months
|
Monthly percentage of days in which the participant was incarcerated, hospitalized, or in residential treatment
|
Up to 18 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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.
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
1. august 2002
Primær færdiggørelse (Faktiske)
1. april 2008
Studieafslutning (Faktiske)
1. april 2008
Datoer for studieregistrering
Først indsendt
6. december 2016
Først indsendt, der opfyldte QC-kriterier
6. december 2016
Først opslået (Skøn)
8. december 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. oktober 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. oktober 2020
Sidst verificeret
1. oktober 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AA013625
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 .