Trial of Adherence App for Buprenorphine Treatment (TAAB) Study

NCT03779997 | Completed Results

• 2 other identifiers: STUDY000050694R44DA044053-02
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

Opioid-Related Disorders

Keywords

Buprenorphine; Directly Observed Therapy; mHealth; Opioid Abuse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Participants Engaged in Treatment at Week 12

  Week 12 post-randomization

Other Outcomes (8)

• Percentage of Participants Engaged in Treatment at Week 24

  Week 24 post-randomization

• Consecutive Weeks Opioid Negative Urine Tests

  Baseline to 12 weeks post-randomization

• Number of Participants With Self-report of Opioid Use

  Week 12 post-randomization

Study Arms (2)

Video-based DOT Application

EXPERIMENTAL

Behavioral: Video-based DOT Application

Treatment as Usual (TAU)

NO INTERVENTION

Interventions

Video-based DOT Application BEHAVIORAL

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.

Video-based DOT Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• Receiving buprenorphine treatment at an office-based buprenorphine program for ≤4 weeks
• Willing to be randomized to either VDOT or TAU

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator
• emocha Mobile Health, Inc.: collaborator

Study Sites (2)

Boston University

Boston, Massachusetts, 02118, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (3)

• 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.

  PMID: 32736660 BACKGROUND

• 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 Alcohol Depend. 2021 Oct 1;227:108917. doi: 10.1016/j.drugalcdep.2021.108917. Epub 2021 Jul 28.

  PMID: 34399136 RESULT

• Radick AC, James J, Leroux BG, Kim TW, Saxon AJ, Samet JH, Tsui JI. Use of Video Directly Observed Therapy and Characteristics Associated With Use Among Patients Treated With Buprenorphine in an Office-based Setting. J Addict Med. 2023 May-Jun 01;17(3):300-304. doi: 10.1097/ADM.0000000000001103. Epub 2022 Oct 25.

  PMID: 37267172 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Directly Observed Therapy

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Limitations of the study included a small sample size and limited power for detecting small but clinically meaningful differences in outcomes. The study did not provide participants with incentives for using the intervention, which may have resulted in low rates of use. Limited provider and clinic staff involvement in the intervention is another limitation that may have affected the uptake of video DOT.

Results Point of Contact

• Title: Judith I. Tsui
• Organization: University of Washington

tsuij@uw.edu

206-744-1835

Study Officials

• Judith I. Tsui, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 19, 2018
• Study Start: February 15, 2019
• Primary Completion: May 15, 2020
• Study Completion: July 29, 2020
• Last Updated: October 6, 2021
• Results First Posted: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)