N/A
Completed N=78
Trial of Adherence App for Buprenorphine Treatment (TAAB) Study
Opioid-Related Disorders
Source: ClinicalTrials.gov NCT03779997 ↗
Enrolled (actual)
78
Serious AEs
15.4%
Results posted
Jul 2021
Primary outcomePrimary: Percentage Opioid Negative Urine Tests — 234; 299 urine drug tests — p=0.07
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Opioid Negative Urine Tests |
234; 299 | 0.07 |
| SECONDARY Percentage of Participants Engaged in Treatment at Week 12 |
27; 32 | 0.20 |
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
Data sourced from ClinicalTrials.gov (NCT03779997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.