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Trial of Adherence App for Buprenorphine Treatment (TAAB) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03779997
Recruitment Status : Completed
First Posted : December 19, 2018
Results First Posted : July 1, 2021
Last Update Posted : October 6, 2021
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
emocha Mobile Health, Inc.
Information provided by (Responsible Party):
Judith I. Tsui, University of Washington

Brief 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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Behavioral: Video-based DOT Application Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Treatment Discharge [ Time Frame: Baseline to 24 weeks post-randomization ]
    Time to discharge from treatment, measured by EHR review.

  6. 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

  7. 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).

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02118
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
National Institute on Drug Abuse (NIDA)
emocha Mobile Health, Inc.
Investigators
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Principal Investigator: Judith I. Tsui, MD, MPH University of Washington
  Study Documents (Full-Text)

Documents provided by Judith I. Tsui, University of Washington:
Publications of Results:
Other Publications:
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Responsible Party: Judith I. Tsui, Associate Professor of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT03779997    
Other Study ID Numbers: STUDY00005069
4R44DA044053-02 ( U.S. NIH Grant/Contract )
First Posted: December 19, 2018    Key Record Dates
Results First Posted: July 1, 2021
Last Update Posted: October 6, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Judith I. Tsui, University of Washington:
Buprenorphine
Directly Observed Therapy
mHealth
Opioid Abuse
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders