Trial of Adherence App for Buprenorphine Treatment (TAAB) Study

September 10, 2021 updated by: Judith I. Tsui, University of Washington

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 weeks post-randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 12 post-randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 24 post-randomization
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.
Baseline to 12 weeks post-randomization
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.
Week 12 post-randomization
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.
Baseline to 12 weeks post-randomization
Treatment Discharge
Time Frame: Baseline to 24 weeks post-randomization
Time to discharge from treatment, measured by EHR review.
Baseline to 24 weeks post-randomization
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
Baseline to 12 weeks post-randomization
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).
Week 12 post-randomization
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.
Week 12 post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute on Drug Abuse (NIDA)
emocha Mobile Health, Inc.

Investigators

  • Principal Investigator: Judith I. Tsui, MD, MPH, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2019

Primary Completion (Actual)

May 15, 2020

Study Completion (Actual)

July 29, 2020

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00005069
  • 4R44DA044053-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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