Trial of Adherence App for Buprenorphine Treatment (TAAB) Study
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|ClinicalTrials.gov Identifier: NCT03779997|
Recruitment Status : Completed
First Posted : December 19, 2018
Results First Posted : July 1, 2021
Last Update Posted : October 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Opioid-Related Disorders||Behavioral: Video-based DOT Application||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Evaluation of Video-Based Directly Observed Therapy for Office-Based Treatment of Opioid Use Disorders With Buprenorphine|
|Actual Study Start Date :||February 15, 2019|
|Actual Primary Completion Date :||May 15, 2020|
|Actual Study Completion Date :||July 29, 2020|
|Experimental: Video-based DOT Application||
Behavioral: 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.
|No Intervention: Treatment as Usual (TAU)|
- Percentage Opioid Negative Urine Tests [ Time Frame: Baseline to 12 weeks post-randomization ]Percentage of weekly study urine drug tests that are negative for opioids, missing assumed to be positive.
- Percentage of Participants Engaged in Treatment at Week 12 [ Time Frame: 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.
- Percentage of Participants Engaged in Treatment at Week 24 [ Time Frame: Week 24 post-randomization ]The percentage of participants engaged in treatment at 24 weeks post-randomization, measured by EHR review.
- Consecutive Weeks Opioid Negative Urine Tests [ Time Frame: Baseline to 12 weeks post-randomization ]The number of consecutive weeks with urine drug test negative for opioids.
- Number of Participants With Self-report of Opioid Use [ Time Frame: Week 12 post-randomization ]Self-reported use of illicit opioids in past 30 days at week 12.
- Buprenorphine Adherence Self-Report [ Time Frame: 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.
- Treatment Discharge [ Time Frame: Baseline to 24 weeks post-randomization ]Time to discharge from treatment, measured by EHR review.
- Buprenorphine Non-use: One or More UDT Negative for Buprenorphine [ Time Frame: Baseline to 12 weeks post-randomization ]Having one or more study urine drug tests negative for buprenorphine
- UDT Positive for Stimulants at Week 12 [ Time Frame: Week 12 post-randomization ]Number of participants having a study urine drug test positive for stimulants (cocaine, amphetamines or methamphetamines).
- Treatment Satisfaction [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779997
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02118|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Judith I. Tsui, MD, MPH||University of Washington|