Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Trial of Adherence App for Buprenorphine Treatment (TAAB) Study

10. september 2021 opdateret af: Judith I. Tsui, University of Washington

Development and Evaluation of Video-Based Directly Observed Therapy for Office-Based Treatment of Opioid Use Disorders With Buprenorphine

The purpose of this study is to pilot test a smartphone application that allows video-based directly observed therapy for participants receiving buprenorphine treatment for opioid use disorder in office-based settings. This application may help participants take their medication more regularly so that they are successful in treatment. Participants will be randomly assigned to either using a smartphone application that allows them to take daily videos confirming their buprenorphine medication ingestion or they will continue with their care as usual (treatment-as-usual or TAU). The primary study outcome will be the percentage of weekly study urine drug tests that are negative for opiates between baseline and 12 weeks post-randomization. The secondary outcome will be engagement in treatment at week 12.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The objective of this study is to compare an innovative mobile health (mHealth) platform to support participants being treated for opioid use disorder (OUD) with buprenorphine to treatment-as-usual (TAU). The application will provide video-based directly observed therapy (VDOT) which may result in better health outcomes for participants and less public health risk for diversion. This study is a randomized controlled trial with two arms: TAU and mHealth intervention. Randomization to the two study arms will be completed using computer randomization procedures. Participants in the intervention group will learn how to use the mHealth application on their personal smartphones or tablets. If a participant does not have access to a personal device or prefers to not use a personal device then a study-provided smartphone will be offered for the duration of the study. Intervention participants are asked to record one daily video of themselves taking buprenorphine. Buprenorphine clinical staff (i.e., physicians, nurses and medical assistants) of patients enrolled in the intervention group will be trained and have the opportunity to review the videos. Adherence for the intervention group will be measured through participation in VDOT, namely the percentage of daily medication doses that are observed through submitted videos. The TAU group will not be given access to the intervention and therefore will not have the opportunity to be exposed to the intervention.

All participants will follow the same visit schedule. Interviews will occur at baseline (Week 0) and the final visit (Week 12) to assess current and prior substance use, treatment history, medication adherence, drug diversion, general physical and mental health and treatment satisfaction. A point of care urine drug test will also be administered which will assess for opiates and other substances. In between the baseline and final visits, participants will meet with research staff weekly to conduct a urine drug test and assess self-reported adherence to buprenorphine. Research staff will review the electronic medical record at baseline and week 12 to assess engagement in treatment. Additionally, at 24 weeks post-enrollment the research staff will complete a review of the electronic medical record and record engagement in clinic treatment, changes in buprenorphine treatment during the study period and the results of any clinical urine drug testing.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

78

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston University
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • University of Washington

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:

  • ≥18 years old
  • Receiving buprenorphine treatment at an office-based buprenorphine program for ≤4 weeks
  • Willing to be randomized to either VDOT or TAU

Exclusion Criteria:

  • Unable or unwilling to use smart phone
  • Cognitive impairment resulting in inability to provide informed consent
  • Researcher's discretion that participant will not be appropriate for participation in the study (e.g. participant is planning on moving away, is knowledgeable of future incarceration during the study, or has behavioral issues that may pose safety concerns for clinic and research staff)
  • Inability to read and understand English as needed for following app instructions

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: Video-based DOT Application
Adfærdsmæssigt: Video-based DOT Application
Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.
Ingen indgriben: Behandling som sædvanlig (TAU)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage Opioid Negative Urine Tests
Tidsramme: Baseline to 12 weeks post-randomization
Percentage of weekly study urine drug tests that are negative for opioids, missing assumed to be positive.
Baseline to 12 weeks post-randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Engaged in Treatment at Week 12
Tidsramme: Week 12 post-randomization
The percentage of participants with an active script for buprenorphine at week 12 (engaged in treatment), measured by electronic health record (EHR) review.
Week 12 post-randomization

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Engaged in Treatment at Week 24
Tidsramme: Week 24 post-randomization
The percentage of participants engaged in treatment at 24 weeks post-randomization, measured by EHR review.
Week 24 post-randomization
Consecutive Weeks Opioid Negative Urine Tests
Tidsramme: Baseline to 12 weeks post-randomization
The number of consecutive weeks with urine drug test negative for opioids.
Baseline to 12 weeks post-randomization
Number of Participants With Self-report of Opioid Use
Tidsramme: Week 12 post-randomization
Self-reported use of illicit opioids in past 30 days at week 12.
Week 12 post-randomization
Buprenorphine Adherence Self-Report
Tidsramme: Baseline to 12 weeks post-randomization
Mean number of days adherent to buprenorphine by self-report over the 12-week study period, using a 7-day timeline-follow-back (TLFB) survey procedure each week. Days with missing data were excluded from analysis.
Baseline to 12 weeks post-randomization
Treatment Discharge
Tidsramme: Baseline to 24 weeks post-randomization
Time to discharge from treatment, measured by EHR review.
Baseline to 24 weeks post-randomization
Buprenorphine Non-use: One or More UDT Negative for Buprenorphine
Tidsramme: Baseline to 12 weeks post-randomization
Having one or more study urine drug tests negative for buprenorphine
Baseline to 12 weeks post-randomization
UDT Positive for Stimulants at Week 12
Tidsramme: Week 12 post-randomization
Number of participants having a study urine drug test positive for stimulants (cocaine, amphetamines or methamphetamines).
Week 12 post-randomization
Treatment Satisfaction
Tidsramme: Week 12 post-randomization
Likert scale survey question of participant's satisfaction with clinic's treatment of opioid use disorder (OUD); on a scale of 1-5, with 1 being very dissatisfied and 5 being very satisfied.
Week 12 post-randomization

Samarbejdspartnere og efterforskere

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

Sponsor

University of Washington

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)
emocha Mobile Health, Inc.

Efterforskere

  • Ledende efterforsker: Judith I. Tsui, MD, MPH, University of Washington

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.

Generelle publikationer

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)

15. februar 2019

Primær færdiggørelse (Faktiske)

15. maj 2020

Studieafslutning (Faktiske)

29. juli 2020

Datoer for studieregistrering

Først indsendt

11. december 2018

Først indsendt, der opfyldte QC-kriterier

17. december 2018

Først opslået (Faktiske)

19. december 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00005069
  • 4R44DA044053-02 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 .

Kliniske forsøg med Opioid-relaterede lidelser

Kliniske forsøg med Video-based DOT Application

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Russia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner