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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02118
- Boston University
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98104
- University of Washington
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Sem intervenção: Tratamento como de costume (TAU)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage Opioid Negative Urine Tests
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants Engaged in Treatment at Week 12
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants Engaged in Treatment at Week 24
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Judith I. Tsui, MD, MPH, University of Washington
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00005069
- 4R44DA044053-02 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .