Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 4R44DA044053-02 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| emocha Mobile Health, Inc. | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video-based DOT Application | Experimental |
| |
| Treatment as Usual (TAU) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Consecutive Weeks Opioid Negative Urine Tests |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Judith I. Tsui, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University | Boston | Massachusetts | 02118 | United States | ||
| University of Washington |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32736660 | Background | 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. | |
| 34399136 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Video-based DOT Application | Video-based directly observed therapy (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. |
| FG001 | Treatment as Usual (TAU) | Treatment-as-usual administered at office-based buprenorphine treatment clinics. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Video-based DOT Application | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Opioid Negative Urine Tests | Percentage of weekly study urine drug tests that are negative for opioids, missing assumed to be positive. | Posted | Count of Units | urine drug tests | Baseline to 12 weeks post-randomization | urine drug tests | urine drug tests |
|
Up to 24 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Video-based DOT Application | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| In-patient hospitalization | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea from medicine | Gastrointestinal disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith I. Tsui | University of Washington | 206-744-1835 | tsuij@uw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2021 | Apr 27, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D023801 | Directly Observed Therapy |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 | Self-reported use of illicit opioids in past 30 days at week 12. | Week 12 post-randomization |
| 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 |
| Treatment Discharge | 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 | Having one or more study urine drug tests negative for buprenorphine | Baseline to 12 weeks post-randomization |
| 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 |
| 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 |
| Seattle |
| Washington |
| 98104 |
| United States |
| 37267172 | Derived | 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. |
| BG001 |
| Treatment as Usual (TAU) |
Office-based buprenorphine treatment |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Study Site | Site of enrollment | Count of Participants | Participants |
|
| Education | Self-reported participant education level | Count of Participants | Participants |
|
| Prior Buprenorphine Treatment | Self-report at baseline of receiving prior buprenorphine treatment prescribed by a doctor (No/Yes). | Count of Participants | Participants |
|
| Homelessness | Self-reported baseline homelessness within the past 3 months. | Count of Participants | Participants |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | Week 12 post-randomization |
|
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | Week 24 post-randomization |
|
|
|
|
| Other Pre-specified | Consecutive Weeks Opioid Negative Urine Tests | The number of consecutive weeks with urine drug test negative for opioids. | Posted | Mean | Standard Deviation | weeks | Baseline to 12 weeks post-randomization | Weeks | Weeks |
|
|
|
|
| Other Pre-specified | Number of Participants With Self-report of Opioid Use | Self-reported use of illicit opioids in past 30 days at week 12. | There were 15 missing survey responses among the video DOT application arm and 9 missing from the TAU arm, these participants were excluded from the analysis. | Posted | Count of Participants | Participants | Week 12 post-randomization |
|
|
|
|
| Other Pre-specified | 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. | Missing days are excluded from analysis. | Posted | Mean | Standard Deviation | days | Baseline to 12 weeks post-randomization | Days | Days |
|
|
|
|
| Other Pre-specified | Treatment Discharge | Time to discharge from treatment, measured by EHR review. | Data was not avaiable on video-based DOT application participants. Therefore, data analysis is not possible. | Posted | Mean | Standard Deviation | Days | Baseline to 24 weeks post-randomization |
|
|
|
| Other Pre-specified | Buprenorphine Non-use: One or More UDT Negative for Buprenorphine | Having one or more study urine drug tests negative for buprenorphine | Posted | Count of Participants | Participants | Baseline to 12 weeks post-randomization |
|
|
|
|
| Other Pre-specified | UDT Positive for Stimulants at Week 12 | Number of participants having a study urine drug test positive for stimulants (cocaine, amphetamines or methamphetamines). | There were 15 missing survey responses among the video DOT application arm and 9 missing from the TAU arm, these participants were excluded from the analysis. | Posted | Count of Participants | Participants | Week 12 post-randomization |
|
|
|
|
| Other Pre-specified | 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. | There were 15 missing survey responses among the video DOT application arm and 9 missing from the TAU arm, these participants were excluded from the analysis. | Posted | Mean | Standard Deviation | score on a scale | Week 12 post-randomization |
|
|
|
|
| 1 |
| 39 |
| 9 |
| 39 |
| 3 |
| 39 |
| EG001 | Treatment as Usual (TAU) | Treatment-as-usual administered at office-based buprenorphine treatment clinics. | 0 | 39 | 3 | 39 | 1 | 39 |
| In-patient hospitalization | Psychiatric disorders | Non-systematic Assessment |
|
| In-patient hospitalization | Infections and infestations | Non-systematic Assessment |
|
| In-patient hospitalization | Cardiac disorders | Non-systematic Assessment |
|
| In-patient hospitalization | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| In-patient hospitalization | General disorders | Non-systematic Assessment |
|
| Pain - lower extremities | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Generall Illness | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |