Trial of Adherence App for Buprenorphine Treatment (TAAB) Study

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT03779997
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), emocha Mobile Health, Inc. (Other)
• Enrollment: 78
• Locations: 2
• Arms: 2
• Actual Duration (Months): 17.4
• Patients Per Site: 39
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Feb 15, 2019
• Actual Primary Completion Date: May 15, 2020
• Actual Study Completion Date: Jul 29, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Percentage Opioid Negative Urine Tests [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 [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 [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 [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 [Week 12 post-randomization]

   Self-reported use of illicit opioids in past 30 days at week 12.

4. Buprenorphine Adherence Self-Report [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 [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 [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 [Week 12 post-randomization]

   Number of participants having a study urine drug test positive for stimulants (cocaine, amphetamines or methamphetamines).

8. Treatment Satisfaction [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston University	Boston	Massachusetts	United States	02118
2	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

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 4, 2021

More Information

Publications

• 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.

• Responsible Party: Judith I. Tsui, Associate Professor of Medicine, University of Washington
• ClinicalTrials.gov Identifier: NCT03779997
• Other Study ID Numbers: STUDY00005069; 4R44DA044053-02
• First Posted: Dec 19, 2018
• Last Update Posted: Oct 6, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Judith I. Tsui, Associate Professor of Medicine, University of Washington: Buprenorphine; Directly Observed Therapy; mHealth; Opioid Abuse
• Additional relevant MeSH terms: Opioid-Related Disorders

Study Results

Participant Flow

Arm/Group Title	Video-based DOT Application	Treatment as Usual (TAU)
Arm/Group Description	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.	Treatment-as-usual administered at office-based buprenorphine treatment clinics.
Period Title: Overall Study
STARTED	39	39
Completed at Least One Visit	39	39
COMPLETED	39	39
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Video-based DOT Application	Treatment as Usual (TAU)	Total
Arm/Group Description	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.	Office-based buprenorphine treatment	Total of all reporting groups
Overall Participants	39	39	78
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.7 (11.9)	40.7 (12.0)	41.7 (11.9)
Sex: Female, Male (Count of Participants)
Female	10 25.6%	10 25.6%	20 25.6%
Male	29 74.4%	29 74.4%	58 74.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	9 23.1%	9 23.1%	18 23.1%
Not Hispanic or Latino	30 76.9%	30 76.9%	60 76.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 5.1%	1 2.6%	3 3.8%
Asian	1 2.6%	2 5.1%	3 3.8%
Native Hawaiian or Other Pacific Islander	2 5.1%	0 0%	2 2.6%
Black or African American	6 15.4%	2 5.1%	8 10.3%
White	23 59%	25 64.1%	48 61.5%
More than one race	4 10.3%	9 23.1%	13 16.7%
Unknown or Not Reported	1 2.6%	0 0%	1 1.3%
Region of Enrollment (participants) [Number]
United States	39 100%	39 100%	78 100%
Study Site (Count of Participants)
Seattle	19 48.7%	19 48.7%	38 48.7%
Boston	20 51.3%	20 51.3%	40 51.3%
Education (Count of Participants)
Less than a high school diploma	7 17.9%	6 15.4%	13 16.7%
High school diploma/GED	13 33.3%	20 51.3%	33 42.3%
Some post-high school	9 23.1%	9 23.1%	18 23.1%
College degree	9 23.1%	4 10.3%	13 16.7%
Postgraduate	1 2.6%	0 0%	1 1.3%
Prior Buprenorphine Treatment (Count of Participants)
No	15 38.5%	19 48.7%	34 43.6%
Yes	24 61.5%	20 51.3%	44 56.4%
Homelessness (Count of Participants)
Not homeless	24 61.5%	23 59%	47 60.3%
Homeless	15 38.5%	16 41%	31 39.7%

Outcome Measures

1. Primary Outcome

Title	Percentage Opioid Negative Urine Tests
Description	Percentage of weekly study urine drug tests that are negative for opioids, missing assumed to be positive.
Time Frame	Baseline to 12 weeks post-randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Video-based DOT Application	Treatment as Usual (TAU)
Arm/Group Description	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.	Treatment-as-usual administered at office-based buprenorphine treatment clinics.
Measure Participants	39	39
Measure urine drug tests	468	468
Count of Units [urine drug tests]	234	299

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Video-based DOT Application, Treatment as Usual (TAU)
	Comments	Null hypothesis: no difference in the percentage of urine drug tests (UDT) negative for opioids between the two treatment arms.Treatment-as-usual (TAU) is the reference group.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments	0.05 a priori threshold for statistical significance.
	Method	Log-linear GEE regression
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 95%; 0.60 to 1.02
	Parameter Dispersion	Type: Standard Deviation; Value: 0.10
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants Engaged in Treatment at Week 12
Description	The percentage of participants with an active script for buprenorphine at week 12 (engaged in treatment), measured by electronic health record (EHR) review.
Time Frame	Week 12 post-randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Video-based DOT Application	Treatment as Usual (TAU)
Arm/Group Description	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.	Treatment-as-usual administered at office-based buprenorphine treatment clinics.
Measure Participants	39	39
Count of Participants [Participants]	27 69.2%	32 82.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Video-based DOT Application, Treatment as Usual (TAU)
	Comments	Null hypothesis: no difference between treatment arms in the percentage of patients engaged in treatment at week 12. TAU is the reference group.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.20
	Comments	0.05 a priori threshold for statistical significance.
	Method	Poisson regression with robust SEs
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95%; 0.65 to 1.10
	Parameter Dispersion	Type: Standard Deviation; Value: 0.11
	Estimation Comments

3. Other Pre-specified Outcome

Title	Percentage of Participants Engaged in Treatment at Week 24
Description	The percentage of participants engaged in treatment at 24 weeks post-randomization, measured by EHR review.
Time Frame	Week 24 post-randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Video-based DOT Application	Treatment as Usual (TAU)
Arm/Group Description	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.	Treatment-as-usual administered at office-based buprenorphine treatment clinics.
Measure Participants	39	39
Count of Participants [Participants]	16 41%	22 56.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Video-based DOT Application, Treatment as Usual (TAU)
	Comments	Null hypothesis: No difference between arms in the percentage of participants engaged in treatment at week 24 post-randomization. TAU is the reference group.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.18
	Comments	0.05 a priori threshold for statistical significance.
	Method	Poisson regression with robust SEs
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.45 to 1.16
	Parameter Dispersion	Type: Standard Deviation; Value: 0.17
	Estimation Comments

4. Other Pre-specified Outcome

Title	Consecutive Weeks Opioid Negative Urine Tests
Description	The number of consecutive weeks with urine drug test negative for opioids.
Time Frame	Baseline to 12 weeks post-randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Video-based DOT Application	Treatment as Usual (TAU)
Arm/Group Description	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.	Treatment-as-usual administered at office-based buprenorphine treatment clinics.
Measure Participants	39	39
Measure Weeks	12	12
Mean (Standard Deviation) [weeks]	4.8 (4.2)	5.7 (3.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Video-based DOT Application, Treatment as Usual (TAU)
	Comments	Null hypothesis: No difference between arms on the number of consecutive weeks with UDT negative for opioids.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.31
	Comments	0.05 a priori threshold for statistical significance.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; -0.9 to 2.7
	Parameter Dispersion	Type: Standard Deviation; Value: 0.45
	Estimation Comments	TAU is the reference group.

5. Other Pre-specified Outcome

Title	Number of Participants With Self-report of Opioid Use
Description	Self-reported use of illicit opioids in past 30 days at week 12.
Time Frame	Week 12 post-randomization

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Video-based DOT Application	Treatment as Usual (TAU)
Arm/Group Description	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.	Treatment-as-usual administered at office-based buprenorphine treatment clinics.
Measure Participants	24	30
Count of Participants [Participants]	4 10.3%	7 17.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Video-based DOT Application, Treatment as Usual (TAU)
	Comments	Null hypothesis: No difference between arms in the number of participants who self-reported illicit opioid use at week 12.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.57
	Comments	0.05 a priori threshold for statistical significance.
	Method	Poisson regression with robust SEs
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 95%; 0.23 to 2.26
	Parameter Dispersion	Type: Standard Deviation; Value: 0.41
	Estimation Comments	TAU is the reference group.

6. Other Pre-specified Outcome

Title	Buprenorphine Adherence Self-Report
Description	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.
Time Frame	Baseline to 12 weeks post-randomization

Outcome Measure Data

Analysis Population Description

Missing days are excluded from analysis.

Arm/Group Title	Video-based DOT Application	Treatment as Usual (TAU)
Arm/Group Description	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.	Treatment-as-usual administered at office-based buprenorphine treatment clinics.
Measure Participants	39	39
Measure Days	281	378
Mean (Standard Deviation) [days]	5.99 (2.18)	5.93 (2.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Video-based DOT Application, Treatment as Usual (TAU)
	Comments	Null hypothesis: No difference between arms in the mean number of days adherent to buprenorphine by self-report.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments	0.05 a priori threshold for statistical significance.
	Method	GEE Poisson regression
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.15
	Parameter Dispersion	Type: Standard Deviation; Value: 0.066
	Estimation Comments	TAU is the reference group.

7. Other Pre-specified Outcome

Title	Treatment Discharge
Description	Time to discharge from treatment, measured by EHR review.
Time Frame	Baseline to 24 weeks post-randomization

Outcome Measure Data

Analysis Population Description

Data was not avaiable on video-based DOT application participants. Therefore, data analysis is not possible.

Arm/Group Title	Video-based DOT Application	Treatment as Usual (TAU)
Arm/Group Description	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.	Treatment-as-usual administered at office-based buprenorphine treatment clinics.
Measure Participants	0	4
Mean (Standard Deviation) [Days]	NA (NA)

8. Other Pre-specified Outcome

Title	Buprenorphine Non-use: One or More UDT Negative for Buprenorphine
Description	Having one or more study urine drug tests negative for buprenorphine
Time Frame	Baseline to 12 weeks post-randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Video-based DOT Application	Treatment as Usual (TAU)
Arm/Group Description	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.	Treatment-as-usual administered at office-based buprenorphine treatment clinics.
Measure Participants	39	39
Count of Participants [Participants]	7 17.9%	6 15.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Video-based DOT Application, Treatment as Usual (TAU)
	Comments	Null hypothesis: No difference between arms in number of participants who had one or more urine drug tests negative for buprenorphine.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.77
	Comments	0.05 a priori threshold for statistical significance.
	Method	Poisson regression with robust SEs
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.17
	Confidence Interval	(2-Sided) 95%; 0.42 to 3.24
	Parameter Dispersion	Type: Standard Deviation; Value: 0.60
	Estimation Comments	TAU is the reference group.

9. Other Pre-specified Outcome

Title	UDT Positive for Stimulants at Week 12
Description	Number of participants having a study urine drug test positive for stimulants (cocaine, amphetamines or methamphetamines).
Time Frame	Week 12 post-randomization

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Video-based DOT Application	Treatment as Usual (TAU)
Arm/Group Description	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.	Treatment-as-usual administered at office-based buprenorphine treatment clinics.
Measure Participants	24	30
Count of Participants [Participants]	7 17.9%	13 33.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Video-based DOT Application, Treatment as Usual (TAU)
	Comments	Null hypothesis: No difference between arms in number of participants who tested positive for stimulants at week 12.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.30
	Comments	0.05 a priori threshold for statistical significance.
	Method	Poisson regression with robust SEs
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.67
	Confidence Interval	(2-Sided) 95%; 0.32 to 1.43
	Parameter Dispersion	Type: Standard Deviation; Value: 0.26
	Estimation Comments	TAU is the reference group.

10. Other Pre-specified Outcome

Title	Treatment Satisfaction
Description	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.
Time Frame	Week 12 post-randomization

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Video-based DOT Application	Treatment as Usual (TAU)
Arm/Group Description	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.	Treatment-as-usual administered at office-based buprenorphine treatment clinics.
Measure Participants	24	30
Mean (Standard Deviation) [score on a scale]	4.6 (0.6)	4.6 (0.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Video-based DOT Application, Treatment as Usual (TAU)
	Comments	Null hypothesis: No difference between arms in mean treatment satisfaction scores
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.91
	Comments	0.05 a priori threshold for statistical significance
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -0.29 to 0.32
	Parameter Dispersion	Type: Standard Deviation; Value: 0.07
	Estimation Comments	TAU is the reference group

Adverse Events

Time Frame	Up to 24 weeks.
Arm/Group Title	Video-based DOT Application		Treatment as Usual (TAU)
Arm/Group Description	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.		Treatment-as-usual administered at office-based buprenorphine treatment clinics.
All Cause Mortality
	Video-based DOT Application		Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/39 (2.6%)		0/39 (0%)
Serious Adverse Events
	Video-based DOT Application		Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/39 (23.1%)		3/39 (7.7%)
Cardiac disorders
In-patient hospitalization	1/39 (2.6%)	1	1/39 (2.6%)	1
General disorders
In-patient hospitalization	1/39 (2.6%)	1	0/39 (0%)	0
Infections and infestations
In-patient hospitalization	1/39 (2.6%)	1	0/39 (0%)	0
Injury, poisoning and procedural complications
In-patient hospitalization	1/39 (2.6%)	1	0/39 (0%)	0
Psychiatric disorders
In-patient hospitalization	4/39 (10.3%)	4	2/39 (5.1%)	2
Skin and subcutaneous tissue disorders
In-patient hospitalization	1/39 (2.6%)	1	0/39 (0%)	0
Other (Not Including Serious) Adverse Events
	Video-based DOT Application		Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/39 (7.7%)		1/39 (2.6%)
Gastrointestinal disorders
Nausea from medicine	0/39 (0%)	0	1/39 (2.6%)	1
General disorders
Generall Illness	2/39 (5.1%)	2	0/39 (0%)	0
Musculoskeletal and connective tissue disorders
Pain - lower extremities	1/39 (2.6%)	1	0/39 (0%)	0

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.