Trial of Adherence App for Buprenorphine Treatment (TAAB) Study

Opioid-Related Disorders Clinical Trial

Official title:

Development and Evaluation of Video-Based Directly Observed Therapy for Office-Based Treatment of Opioid Use Disorders With Buprenorphine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03779997
• Other study ID #: STUDY00005069
• Secondary ID: 4R44DA044053-02
• Status: Completed
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: July 29, 2020

Study information

• Verified date: June 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 29, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	emocha Mobile Health, Inc., National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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 Alc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Engaged in Treatment at Week 24	The percentage of participants engaged in treatment at 24 weeks post-randomization, measured by EHR review.	Week 24 post-randomization
Other	Consecutive Weeks Opioid Negative Urine Tests	The number of consecutive weeks with urine drug test negative for opioids.	Baseline to 12 weeks post-randomization
Other	Number of Participants With Self-report of Opioid Use	Self-reported use of illicit opioids in past 30 days at week 12.	Week 12 post-randomization
Other	Buprenorphine Adherence Self-Report	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
Other	Treatment Discharge	Time to discharge from treatment, measured by EHR review.	Baseline to 24 weeks post-randomization
Other	Buprenorphine Non-use: One or More UDT Negative for Buprenorphine	Having one or more study urine drug tests negative for buprenorphine	Baseline to 12 weeks post-randomization
Other	UDT Positive for Stimulants at Week 12	Number of participants having a study urine drug test positive for stimulants (cocaine, amphetamines or methamphetamines).	Week 12 post-randomization
Other	Treatment Satisfaction	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
Primary	Percentage Opioid Negative Urine Tests	Percentage of weekly study urine drug tests that are negative for opioids, missing assumed to be positive.	Baseline to 12 weeks post-randomization
Secondary	Percentage of Participants Engaged in Treatment at Week 12	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