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
Abstract Background Office-based buprenorphine treatment of opioid use disorder (OUD) does not typically include in-person directly observed therapy (DOT), potentially leading to non-adherence. Video DOT technologies may safeguard against this issue and thus enhance likelihood of treatment success....
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| Format: | Article |
| Language: | English |
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BMC
2020-07-01
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| Series: | Addiction Science & Clinical Practice |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13722-020-00203-9 |
| _version_ | 1828431628123242496 |
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| author | Zachery A. Schramm Brian G. Leroux Andrea C. Radick Alicia S. Ventura Jared W. Klein Jeffrey H. Samet Andrew J. Saxon Theresa W. Kim Judith I. Tsui |
| author_facet | Zachery A. Schramm Brian G. Leroux Andrea C. Radick Alicia S. Ventura Jared W. Klein Jeffrey H. Samet Andrew J. Saxon Theresa W. Kim Judith I. Tsui |
| author_sort | Zachery A. Schramm |
| collection | DOAJ |
| description | Abstract Background Office-based buprenorphine treatment of opioid use disorder (OUD) does not typically include in-person directly observed therapy (DOT), potentially leading to non-adherence. Video DOT technologies may safeguard against this issue and thus enhance likelihood of treatment success. We describe the rationale and protocol for the Trial of Adherence Application for Buprenorphine treatment (TAAB) study, a pilot randomized controlled trial (RCT) to evaluate the effects of video DOT delivered via a smartphone app on office-based buprenorphine treatment outcomes, namely illicit opioid use and retention. Methods Participants will be recruited from office-based opioid addiction treatment programs in outpatient clinics at two urban medical centers and randomized to either video DOT (intervention) delivered via a HIPAA-compliant, asynchronous, mobile health (mHealth) technology platform, or treatment-as-usual (control). Eligibility criteria are: 18 years or older, prescribed sublingual buprenorphine for a cumulative total of 28 days or less from the office-based opioid treatment program, and able to read and understand English. Patients will be considered ineligible if they are unable or unwilling to use the intervention, provide consent, or complete weekly study visits. All participants will complete 13 in-person weekly visits and be followed via electronic health record data capture at 12- and 24-weeks post-randomization. Data gathered include the following: demographics; current and previous treatment for OUD; self-reported diversion of prescribed buprenorphine; status of their mental and physical health; and self-reported lifetime and past 30-day illicit substance use. Participants provide urine samples at each weekly visit to test for illicit drugs and buprenorphine. The primary outcome is percentage of weekly urines that are negative for opioids over the 12-weeks. The secondary outcome is engagement in treatment at week 12. Discussion Video DOT delivered through mHealth technology platform offers possibility of improving patients’ buprenorphine adherence by providing additional structure and accountability. The TAAB study will provide important preliminary estimates of the impact of this mHealth technology for patients initiating buprenorphine, as well as the feasibility of study procedures, thus paving the way for further research to assess feasibility and generate preliminary data for design of a future Phase III trial. Trial Registration ClinicalTrails.gov, NCT03779997, Registered on December 19, 2018. |
| first_indexed | 2024-12-10T18:06:04Z |
| format | Article |
| id | doaj.art-54347ccf91c5479487d4a10c6fce6699 |
| institution | Directory Open Access Journal |
| issn | 1940-0640 |
| language | English |
| last_indexed | 2024-12-10T18:06:04Z |
| publishDate | 2020-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Addiction Science & Clinical Practice |
| spelling | doaj.art-54347ccf91c5479487d4a10c6fce66992022-12-22T01:38:36ZengBMCAddiction Science & Clinical Practice1940-06402020-07-0115111710.1186/s13722-020-00203-9Video 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 trialZachery A. Schramm0Brian G. Leroux1Andrea C. Radick2Alicia S. Ventura3Jared W. Klein4Jeffrey H. Samet5Andrew J. Saxon6Theresa W. Kim7Judith I. Tsui8Division of General Internal Medicine, Department of Medicine, University of WashingtonDepartment of Biostatistics, University of WashingtonDivision of General Internal Medicine, Department of Medicine, University of WashingtonClinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston University School of Medicine and Boston Medical CenterDivision of General Internal Medicine, Department of Medicine, University of WashingtonDepartment of Community Health Sciences, Boston University School of Public HealthCenter of Excellence in Substance Abuse Treatment and Education, VA Puget Sound Health Care SystemClinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston University School of Medicine and Boston Medical CenterDivision of General Internal Medicine, Department of Medicine, University of WashingtonAbstract Background Office-based buprenorphine treatment of opioid use disorder (OUD) does not typically include in-person directly observed therapy (DOT), potentially leading to non-adherence. Video DOT technologies may safeguard against this issue and thus enhance likelihood of treatment success. We describe the rationale and protocol for the Trial of Adherence Application for Buprenorphine treatment (TAAB) study, a pilot randomized controlled trial (RCT) to evaluate the effects of video DOT delivered via a smartphone app on office-based buprenorphine treatment outcomes, namely illicit opioid use and retention. Methods Participants will be recruited from office-based opioid addiction treatment programs in outpatient clinics at two urban medical centers and randomized to either video DOT (intervention) delivered via a HIPAA-compliant, asynchronous, mobile health (mHealth) technology platform, or treatment-as-usual (control). Eligibility criteria are: 18 years or older, prescribed sublingual buprenorphine for a cumulative total of 28 days or less from the office-based opioid treatment program, and able to read and understand English. Patients will be considered ineligible if they are unable or unwilling to use the intervention, provide consent, or complete weekly study visits. All participants will complete 13 in-person weekly visits and be followed via electronic health record data capture at 12- and 24-weeks post-randomization. Data gathered include the following: demographics; current and previous treatment for OUD; self-reported diversion of prescribed buprenorphine; status of their mental and physical health; and self-reported lifetime and past 30-day illicit substance use. Participants provide urine samples at each weekly visit to test for illicit drugs and buprenorphine. The primary outcome is percentage of weekly urines that are negative for opioids over the 12-weeks. The secondary outcome is engagement in treatment at week 12. Discussion Video DOT delivered through mHealth technology platform offers possibility of improving patients’ buprenorphine adherence by providing additional structure and accountability. The TAAB study will provide important preliminary estimates of the impact of this mHealth technology for patients initiating buprenorphine, as well as the feasibility of study procedures, thus paving the way for further research to assess feasibility and generate preliminary data for design of a future Phase III trial. Trial Registration ClinicalTrails.gov, NCT03779997, Registered on December 19, 2018.http://link.springer.com/article/10.1186/s13722-020-00203-9Medication adherenceMobile healthmHealthOpioid related disordersBuprenorphineDirectly observed therapy |
| spellingShingle | Zachery A. Schramm Brian G. Leroux Andrea C. Radick Alicia S. Ventura Jared W. Klein Jeffrey H. Samet Andrew J. Saxon Theresa W. Kim Judith I. Tsui 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 Addiction Science & Clinical Practice Medication adherence Mobile health mHealth Opioid related disorders Buprenorphine Directly observed therapy |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Medication adherence Mobile health mHealth Opioid related disorders Buprenorphine Directly observed therapy |
| url | http://link.springer.com/article/10.1186/s13722-020-00203-9 |
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