Trial of Adherence App for Buprenorphine Treatment (TAAB) Study

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.

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