Trial of Adherence App for Buprenorphine Treatment (TAAB) Study
Development and Evaluation of Video-Based Directly Observed Therapy for Office-Based Treatment of Opioid Use Disorders With Buprenorphine
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02118
- Boston University
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98104
- University of Washington
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Inget ingripande: Behandling som vanligt (TAU)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage Opioid Negative Urine Tests
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants Engaged in Treatment at Week 12
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants Engaged in Treatment at Week 24
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Judith I. Tsui, MD, MPH, University of Washington
Publikationer och användbara länkar
Allmänna publikationer
- Schramm ZA, Leroux BG, Radick AC, Ventura AS, Klein JW, Samet JH, Saxon AJ, Kim TW, Tsui JI. Video directly observed therapy intervention using a mobile health application among opioid use disorder patients receiving office-based buprenorphine treatment: protocol for a pilot randomized controlled trial. Addict Sci Clin Pract. 2020 Jul 31;15(1):30. doi: 10.1186/s13722-020-00203-9.
- Tsui JI, Leroux BG, Radick AC, Schramm ZA, Blalock K, Labelle C, Heerema M, Klein JW, Merrill JO, Saxon AJ, Samet JH, Kim TW. Video directly observed therapy for patients receiving office-based buprenorphine - A pilot randomized controlled trial. Drug Alcohol Depend. 2021 Oct 1;227:108917. doi: 10.1016/j.drugalcdep.2021.108917. Epub 2021 Jul 28.
- Radick AC, James J, Leroux BG, Kim TW, Saxon AJ, Samet JH, Tsui JI. Use of Video Directly Observed Therapy and Characteristics Associated With Use Among Patients Treated With Buprenorphine in an Office-based Setting. J Addict Med. 2022 Oct 24. doi: 10.1097/ADM.0000000000001103. Online ahead of print.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY00005069
- 4R44DA044053-02 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Opioidrelaterade störningar
-
University of Southern DenmarkVejle Hospital; Vejle KommuneAvslutadHRQOL (Health Related Quality Of Life)Danmark
-
University of Southern DenmarkNaestved HospitalAvslutadHRQOL (Health Related Quality of Quality)Danmark
-
matthieu clanetAvslutad
-
University of North Carolina, Chapel HillNorth Carolina Department of Health and Human ServicesAvslutadAnalgetika OpioidFörenta staterna
-
Second Hospital of Shanxi Medical UniversityRekryteringOpioid smärtstillande biverkningKina
-
Massachusetts General HospitalAvslutadGraviditet | Kejsarsnitt | Analgetika, Opioid | ReceptFörenta staterna
-
Jagiellonian UniversityRekryteringAnestesi, general | Analgetika, Opioid | Anestesi, EndotrakealPolen
-
Jagiellonian UniversityRekryteringAnalgetika, Opioid | Anestesi; Skadlig effektPolen
-
University of MalayaAvslutadTrauma | Opioid smärtstillande biverkningMalaysia
-
Qianfoshan HospitalHar inte rekryterat ännuAnalgetika, opioid | Bariatrisk kirurgiKina
Kliniska prövningar på Video-based DOT Application
-
Centers for Disease Control and PreventionColumbia University; New York City Department of Health and Mental HygieneAvslutadTuberkulos | Följsamhet, medicinering | Läkemedelsresistent tuberkulos | Följsamhet, tålmodigFörenta staterna
-
University of GeorgiaMakerere UniversityAvslutad
-
Ankara Yildirim Beyazıt UniversityHar inte rekryterat ännu
-
University of TorontoRekrytering
-
Johns Hopkins UniversityCenters for Disease Control and PreventionAvslutadStörning av opioidanvändningFörenta staterna
-
University of California, San DiegoAvslutadTuberkulos | Latent tuberkulosinfektionFörenta staterna
-
Harvard School of Public Health (HSPH)Bristol-Myers Squibb; McGill University Health Centre/Research Institute... och andra samarbetspartnersAvslutadHIV-infektion | AIDSBotswana