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Kontorbaseret metadon versus buprenorphin til behandling af retention i medicin til behandling af opioidbrugsforstyrrelser.

9. september 2026 opdateret af: Yale University

Kontorbaseret metadon versus buprenorphin til behandling af retention i medicin til behandling af opioidbrugsforstyrrelser - et pragmatisk hybrid effektivitets-/implementeringsforsøg

Formålet med dette kliniske forsøg er at sammenligne effektiviteten af ​​kontorbaseret metadon med apoteksadministration og/eller dispensering med kontorbaseret buprenorphin til behandling af opioidbrugsforstyrrelser. Denne undersøgelse vil også undersøge faktorer, der påvirker implementeringen af ​​kontorbaseret metadon.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Denne undersøgelse er et randomiseret, pragmatisk hybrid type 1 effektivitet/implementering multisite (ca. 6 steder) forsøg for at bestemme, om kontorbaseret metadon med apoteksadministration og/eller dispensering eller buprenorphin (BUP) resulterer i større behandlingsretention hos ca. 600 patienter med opioid brugsforstyrrelse (OUD). Dette forsøg vil også identificere implementeringsbarrierer, facilitatorer og acceptabilitet på patient-, udbyder- og sundhedssystemniveau for kontorbaseret metadon med apoteksadministration og/eller -udlevering.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

600

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • California
      • Oakland, California, Forenede Stater, 94602
        • Rekruttering
        • Highland Hospital Bridge Clinic at Alameda Health System
        • Ledende efterforsker:
          • Monish Ullal, MD
        • Kontakt:
      • San Francisco, California, Forenede Stater, 94103
        • Rekruttering
        • Outpatient Buprenorphine Induction Clinic, University of California, San Francisco
        • Ledende efterforsker:
          • Paula Lum, MD
        • Ledende efterforsker:
          • Andy Tompkins, MD
        • Underforsker:
          • Christine Soran, MD
        • Kontakt:
    • Colorado
      • Denver, Colorado, Forenede Stater, 80205
        • Rekruttering
        • Rapid Start Clinic, Kaiser Permanente Colorado
        • Ledende efterforsker:
          • Ingrid Binswanger, MD
        • Kontakt:
          • Jennifer Barrow
          • Telefonnummer: (303)-739-3666
          • E-mail: EMBOSS@kp.org
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Rekruttering
        • Officed Based Addiction Treatment Program, Boston Medical Center
        • Ledende efterforsker:
          • Zoe Weinstein, MD
        • Kontakt:
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Rekruttering
        • Hennepin Healthcare Addiction Medicine
        • Ledende efterforsker:
          • Gavin Bart, MD
        • Kontakt:
    • West Virginia
      • Huntington, West Virginia, Forenede Stater, 25703
        • Rekruttering
        • Marshall University Division of Addiction Sciences P.R.O.A.C.T
        • Ledende efterforsker:
          • Zachary Hansen, MD
        • Underforsker:
          • Todd Davies, PhD
        • Kontakt:

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

  • 18 år eller ældre;
  • Opfyld Diagnostisk og Statistisk Manual of Mental Disorders, 5. udgave (DSM-5) kriterier for OUD;
  • Påbegynder en ny MOUD behandlingsepisode

Eksklusionskriterier

  • Er blevet ordineret (og indtaget) eller blevet administreret mere end 72 timers MOUD i de 7 dage før randomisering som en "bro" til den nye OUD-behandlingsepisode. Sådan MOUD kan omfatte ordineret (og indtaget) eller administreret medicinsk styret abstinens (alias afgiftning).
  • Kendt kontraindikation for metadon eller BUP
  • Uvillig til at forfølge eller fortsætte prænatal pleje eller graviditetsrådgivning, hvis det konstateres gravid ved human choriongonadotropin (hCG)-test i urin ved screeningsvurderingen
  • Være aktivt suicidal eller svært kognitivt svækket (f.eks. demens, ubehandlet psykose), hvilket udelukker informeret samtykke som bestemt af klinikeren
  • Aktuel alvorlig comorbid stofbrugsforstyrrelse, der kræver behandling i hjemmet eller døgnbehandling som bestemt af klinikeren
  • Være ude af stand til eller uvillig til at give pålidelige lokaliseringsoplysninger, herunder 2 eller flere kontakter ud over dem selv
  • Være uvillig til at følge undersøgelsesprocedurer (f.eks. uvillig til at modtage behandling fra stedets kliniker, bruge undersøgelsesapoteket, uvillig til at blive randomiseret til BUP eller metadon, eller vil være utilgængelig for de opfølgende vurderinger), herunder at give forskerne adgang til deres journal i EMR og statens overvågningsprogram for receptpligtig medicin
  • Har tidligere tilmeldt CTN-0131
  • Er i øjeblikket tilmeldt en anden forskningsundersøgelse, som vil være i konflikt med undersøgelsesprocedurer
  • Er i øjeblikket i fængsel, fængsel eller anden overnatningsfacilitet som krævet af en domstol eller har verserende retssager, der kan forhindre deltagelse i studieaktiviteter
  • Ude af stand til at udføre forskningsvurderinger på engelsk som bestemt af Site PI eller deres udpegede.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Kontorbaseret metadon
Under den særlige Drug Enforcement Administration (DEA) undtagelse ordinerer klinikeren metadon, og oral metadon administreres og/eller udleveres på et apotek, som også har en undtagelse hertil. Alle deltagere i randomiseret kontrolleret forsøg (RCT) tilbydes yderligere adfærdsbehandlinger (f.eks. individuel, gruppe, telesundhed, telefonbaseret).
Medicin: Metadon

Lægemiddel: metadon

Mulige formuleringer:

10 og 50 mg tabletter
Aktiv komparator: Kontorbaseret buprenorphin (BUP)
Klinikeren ordinerer BUP-formuleringer, der udleveres på et apotek eller administreres på kontoret (f.eks. formuleringer med forlænget frigivelse). Alle RCT-deltagere tilbydes yderligere adfærdsbehandlinger (f.eks. individuel, gruppe, telesundhed, telefonbaseret).
Medicin: Buprenorphine (BUP)

Drug: Buprenorphine (BUP)

Possible formulations:

A. Buprenorphine, 225 mcg to 24 mg, 225 mcg to 32 mg per day,

B. Buprenorphine (Extended release), 300 mg q 28 days (Sublocade), 100 mg q 28 days (Sublocade), 8 mg q 7 days (Brixadi), 16 mg q 7 days (Brixadi), 24 mg q 7 days (Brixadi), 32 mg q 7 days (Brixadi), 64 mg q 28 days (Brixadi), 96 mg q 28 days (Brixadi), 128 mg q 28 days (Brixadi),

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of days of continuous treatment with site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants.
Tidsramme: up to Day 168
This measure is based on PDMP data for methadone and non-injectable buprenorphine and EMR data for injectable buprenorphine formulations
up to Day 168

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Deltagertilfredshed med MOUD
Tidsramme: op til dag 168
Andel af RCT-deltagere, der rapporterer ved vurderingen, der er planlagt til at blive indsamlet på dag 28, at den medicin, de modtog, i det mindste var "Somewhat helpful" på Satisfaction with MOUD Provider Scale-instrumentet.
op til dag 168
Samlet antal selvrapporterede overdosishændelser pr. samlet antal deltagerdage i risikozonen.
Tidsramme: op til dag 168
Overdose Calendar Recall-instrumentet indsamler overdosishændelser.
op til dag 168
Number of self-reported continuous treatment days in any FDA-approved formulation of MOUD treatment during the 168 days post-randomization.
Tidsramme: up to Day 168
This measure is assessed using the MOUD Calendar Based Recall Recall Instruments.
up to Day 168
Number of self-reported continuous treatment days in formal OUD treatment, according to American Society of Addiction Medicine (ASAM) levels of care 1-4, during the 168 days post-randomization.
Tidsramme: up to Day 168

This measure is assessed using one or more of the following:

The Health Services Utilization instrument, a brief structured interview regarding health care utilization (inpatient and outpatient) collecting information on the type and amount of services received, Timeline Followback Medications, MOUD Calendar Based Recall, and Treatment Dates instruments.
up to Day 168
Total number of days receiving any FDA-approved MOUD formulation during the 168 days post-randomization.
Tidsramme: up to Day 168
This measure is assessed using EMR (for injectable MOUD formulations) and PDMP data.
up to Day 168
The longest duration of continuous treatment episode with MOUD, as randomized, during the 168 days post randomization.
Tidsramme: up to Day 168
This measure is based on PDMP and/or EMR data.
up to Day 168
Total number of days receiving methadone or buprenorphine, during the 168 days post-randomization.
Tidsramme: up to Day 168
This measure is assessed using EMR (for injectable MOUD formulations) and PDMP data.
up to Day 168
Total number of days of self-reported non-prescribed opioid use during each 28-day assessment period.
Tidsramme: up to Day 168
This measure is assessed by the Opioid Use Calendar Based Recall instruments.
up to Day 168
Total number of days of self-reported non-prescribed stimulant use during each 28-day assessment period.
Tidsramme: up to Day 168
This measure is assessed by the Timeline Followback instrument.
up to Day 168
Total number of days of self-reported non-prescribed benzodiazepine use during each 28-day assessment period.
Tidsramme: up to Day 168
This measure is assessed by the Timeline Followback instrument.
up to Day 168
Urine toxicology
Tidsramme: up to Day 168
Total number of monthly (28 days) urines negative for non-prescribed opioids during the 168 days post-randomization. Non-prescribed opioids will be determined using the Opioid Use Calendar Based Recall instrument.
up to Day 168
Total number of self-reported injection drug use related events during each 28-day assessment period.
Tidsramme: Up to Day 168
Assessment of Infectious or Other Complications of Injection Drug Use assess for skin abscesses, ulcers , cellulitis, osteoarticular septic arthritis, osteomyelitis, epidural infection , endovascular, new injection-related viral infections diagnosis of Hepatitis or HIV.
Up to Day 168
Mean score Pain measured using Pain, Enjoyment of Life and General Activity (PEG) Scale (PEG-3)
Tidsramme: Up to Day 168
Mean scores on the PEG-3 instrument over time. The PEG-3 instrument is collected every 28 days. The mean score is the average of the three 0-10 rated items. Total score range 0-10. Higher scores indicate worse pain.
Up to Day 168
Total number of self-reported days with acute care utilization (ED or hospitalization) during each 28-day assessment period.
Tidsramme: Up to Day 168
The Health Services Utilization instrument is a brief, structured interview regarding health care utilization (inpatient and outpatient) collecting information on the type and amount of services received. This includes ED visits, hospitalizations, primary medical care visits (excluding those for BUP treatment) and self-help sources of support (e.g., NA). Also assessed are receipt of formal and informal addiction and mental health treatment services RCT participants might have received outside the study interventions.
Up to Day 168
Total number of behavioral counseling service visits attended per participant during each 28-day assessment period.
Tidsramme: Up to Day 168
Assessed by EMR extraction and the Health Services Utilization.
Up to Day 168
Total number of planned prescriber visits attended during each 28-day assessment period.
Tidsramme: Up to Day 168
Assessed by EMR extraction.
Up to Day 168
Pharmacist practice fidelity
Tidsramme: Up to Day 168
Assessed by MOUD Visit Checklist completion over time. The MOUD Visit Checklist collects clinical activities that might be performed by a pharmacist at each pharmacy, such as performing medication reconciliation; conducting safety assessments, adverse effects of methadone, recent overdose events, checking the patient's controlled medications prescription status using the PDMP before dispensing methadone; providing patient education/counseling; communicating with the clinician regarding any concern; and administering one methadone dose at the pharmacy and/or dispensing methadone according to the prescription.
Up to Day 168

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Retention in office-based methadone treatment
Tidsramme: Starting at day 168 post enrollment up to 2years
Retention will be defined as the number of days of continuous office-based methadone treatment (time to event outcome) staring at day 168. Discontinuation of methadone for the extended study component will be defined as more than a self-reported 30-day gap in receipt of methadone or non-response on two consecutive 60-day assessments. The date of discontinuation will be the end of the last 30-day period with any self-reported office-based methadone treatment. Participants who remain in continuous treatment through the end of the study and will be censored on day of the last 60 day assessment. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Percentage of days covered of self-reported pharmacy dispensed methadone treatment
Tidsramme: starting at day 168 post enrollment up to 2 years
Percentage of days covered of self-reported pharmacy dispensed methadone treatment (i.e., number of self-reported days covered per total days observed). Only collected in extended study participants.
starting at day 168 post enrollment up to 2 years
Total number of self-reported overdose events
Tidsramme: Starting at day 168 post enrollment up to 2years
To assess overdose events, participants will self-report the number of overdose events in the past 28 days. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Methadone dose
Tidsramme: Starting at day 168 post enrollment up to 2years
Participants will self-report the most recent daily dose (in milligrams) of methadone prescribed and obtained from the pharmacy. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Days of treatment
Tidsramme: Starting at day 168 post enrollment up to 2years
Days of treatment will be the count of self-reported number of days the participant self reported taking prescribed methadone. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Treatment Effectiveness Assessment (TEA)
Tidsramme: Starting at day 168 post enrollment up to 2years
The TEA collects self-report data across four domains: substance use, health, lifestyle, and community. This will be analyzed as a repeated measure of overall numerical score. Total score range 4-40. higher scores mean greater improvement. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Health service utilization
Tidsramme: Starting at day 168 post enrollment up to 2years
Participants will be asked to report the inpatient and outpatient services they used in the past 28 days. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Health related quality of life
Tidsramme: Starting at day 168 post enrollment up to 2years
To assess health related quality of life, participants will self-report their general health, physical health, and mental health during the past 28 days. This will be analyzed as a repeated measure of overall numerical score. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Crime and criminal justice involvement
Tidsramme: Starting at day 168 post enrollment up to 2years
To assess crime and criminal justice, participants will self-report how many days in the past 60 days they have been incarcerated, if they have been in contact with the court, criminal justice system, or probation/parole officer and how many of those days in the past 60 they were incarcerated, in contact with the court, criminal justice system or probation/parole officer. Criminal justice involvement will be defined as the percentage of days of self-reported involvement (i.e., number of self-reported days per total days observed). Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
End of study status
Tidsramme: Starting at day 168 post enrollment up to 2years
End of study status for participants which includes; office-based methadone treatment at end of study, withdrew consent, deceased, unable to contact, no longer being prescribed methadone from the site. End of study status will be reported by study site Research Associates or Site Clinicians. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Substance use
Tidsramme: Starting at day 168 post enrollment up to 2years
To assess substance use, participants will self-report how many of the past 60 days that they used a substance. Monthly substance use obtained through survey assessment at each 60- day assessment. Total number of days of self-reported substance use during each 60 day assessment period (discrete or continuous outcome, repeated measure). Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Yale University

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
University of California, San Francisco
Kaiser Permanente
The Emmes Company, LLC
Hennepin Healthcare Research Institute
Alameda Health System
Boston Medical Center (BMC)
Marshall Health

Efterforskere

  • Ledende efterforsker: David Fiellin, MD, Yale 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)

4. juni 2024

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

13. marts 2023

Først indsendt, der opfyldte QC-kriterier

14. marts 2024

Først opslået (Faktiske)

21. marts 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2000033271
  • CTN-0131 (Anden identifikator: Clinical Trials Network)
  • 5UG1DA015831-21 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

National Institute on Drug Abuse (NIDA) Data Share-websted er et elektronisk miljø, der gør det muligt at distribuere data fra afsluttede kliniske forsøg til efterforskere og offentligheden for at fremme ny forskning, tilskynde til yderligere analyser og formidle information til samfundet. Sekundære analyser produceret fra datadeling multiplicerer det videnskabelige bidrag fra den oprindelige forskning. NIH forventer og støtter rettidig frigivelse og deling af endelige forskningsdata fra NIH-støttede undersøgelser til brug for andre forskere for at fremskynde oversættelsen af ​​forskningsresultater til viden, produkter og procedurer til forbedring af menneskers sundhed.

IPD-delingstidsramme

Datasæt vil være tilgængelige efter (1) det primære papir er blevet accepteret til offentliggørelse, eller (2) dataene er låst i mere end 18 måneder, alt efter hvad der kommer først.

IPD-delingsadgangskriterier

Offentlig

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

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 .

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