Clinical trial NCT03779997: Trial of Adherence App for Buprenorphine Treatment (TAAB) Study
Official title: Development and Evaluation of Video-Based Directly Observed Therapy for Office-Based Treatment of Opioid Use Disorders With Buprenorphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Keywords: Buprenorphine
Directly Observed Therapy
mHealth
Opioid Abuse
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: emocha Mobile Health, Inc.
First posted: 2018-12-19
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage Opioid Negative Urine Tests
timeFrame: Baseline to 12 weeks post-randomization
Secondary outcomes:
measure: Percentage of Participants Engaged in Treatment at Week 12
timeFrame: Week 12 post-randomization
Other outcomes:
measure: Percentage of Participants Engaged in Treatment at Week 24
timeFrame: Week 24 post-randomization
measure: Consecutive Weeks Opioid Negative Urine Tests
timeFrame: Baseline to 12 weeks post-randomization
measure: Number of Participants With Self-report of Opioid Use
timeFrame: Week 12 post-randomization
measure: Buprenorphine Adherence Self-Report
timeFrame: Baseline to 12 weeks post-randomization
measure: Treatment Discharge
timeFrame: Baseline to 24 weeks post-randomization
measure: Buprenorphine Non-use: One or More UDT Negative for Buprenorphine
timeFrame: Baseline to 12 weeks post-randomization
measure: UDT Positive for Stimulants at Week 12
timeFrame: Week 12 post-randomization
measure: Treatment Satisfaction
timeFrame: Week 12 post-randomization
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Judith I. Tsui, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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 24:10.1097/ADM.0000000000001103. doi: 10.1097/ADM.0000000000001103. Online ahead of print.