Trial Outcomes & Findings for Trial of Adherence App for Buprenorphine Treatment (TAAB) Study (NCT NCT03779997)
NCT ID: NCT03779997
Last Updated: 2021-10-06
Results Overview
Percentage of weekly study urine drug tests that are negative for opioids, missing assumed to be positive.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
Baseline to 12 weeks post-randomization
Results posted on
2021-10-06
Participant Flow
Participant milestones
| Measure |
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.
|
Treatment as Usual (TAU)
Treatment-as-usual administered at office-based buprenorphine treatment clinics.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
|
Overall Study
Completed at Least One Visit
|
39
|
39
|
|
Overall Study
COMPLETED
|
39
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Adherence App for Buprenorphine Treatment (TAAB) Study
Baseline characteristics by cohort
| Measure |
Video-based DOT Application
n=39 Participants
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 (TAU)
n=39 Participants
Office-based buprenorphine treatment
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
41.7 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
39 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Study Site
Seattle
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Study Site
Boston
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Education
Less than a high school diploma
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Education
High school diploma/GED
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Education
Some post-high school
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Education
College degree
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Education
Postgraduate
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Prior Buprenorphine Treatment
No
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Prior Buprenorphine Treatment
Yes
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Homelessness
Not homeless
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Homelessness
Homeless
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeks post-randomizationPercentage of weekly study urine drug tests that are negative for opioids, missing assumed to be positive.
Outcome measures
| Measure |
Video-based DOT Application
n=468 urine drug tests
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 (TAU)
n=468 urine drug tests
Treatment-as-usual administered at office-based buprenorphine treatment clinics.
|
|---|---|---|
|
Percentage Opioid Negative Urine Tests
|
234 urine drug tests
|
299 urine drug tests
|
SECONDARY outcome
Timeframe: Week 12 post-randomizationThe percentage of participants with an active script for buprenorphine at week 12 (engaged in treatment), measured by electronic health record (EHR) review.
Outcome measures
| Measure |
Video-based DOT Application
n=39 Participants
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 (TAU)
n=39 Participants
Treatment-as-usual administered at office-based buprenorphine treatment clinics.
|
|---|---|---|
|
Percentage of Participants Engaged in Treatment at Week 12
|
27 Participants
|
32 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 24 post-randomizationThe percentage of participants engaged in treatment at 24 weeks post-randomization, measured by EHR review.
Outcome measures
| Measure |
Video-based DOT Application
n=39 Participants
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 (TAU)
n=39 Participants
Treatment-as-usual administered at office-based buprenorphine treatment clinics.
|
|---|---|---|
|
Percentage of Participants Engaged in Treatment at Week 24
|
16 Participants
|
22 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 12 weeks post-randomizationThe number of consecutive weeks with urine drug test negative for opioids.
Outcome measures
| Measure |
Video-based DOT Application
n=12 Weeks
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 (TAU)
n=12 Weeks
Treatment-as-usual administered at office-based buprenorphine treatment clinics.
|
|---|---|---|
|
Consecutive Weeks Opioid Negative Urine Tests
|
4.8 weeks
Standard Deviation 4.2
|
5.7 weeks
Standard Deviation 3.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12 post-randomizationPopulation: 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.
Self-reported use of illicit opioids in past 30 days at week 12.
Outcome measures
| Measure |
Video-based DOT Application
n=24 Participants
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 (TAU)
n=30 Participants
Treatment-as-usual administered at office-based buprenorphine treatment clinics.
|
|---|---|---|
|
Number of Participants With Self-report of Opioid Use
|
4 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 12 weeks post-randomizationPopulation: Missing days are excluded from analysis.
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.
Outcome measures
| Measure |
Video-based DOT Application
n=281 Days
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 (TAU)
n=378 Days
Treatment-as-usual administered at office-based buprenorphine treatment clinics.
|
|---|---|---|
|
Buprenorphine Adherence Self-Report
|
5.99 days
Standard Deviation 2.18
|
5.93 days
Standard Deviation 2.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 24 weeks post-randomizationPopulation: Data was not avaiable on video-based DOT application participants. Therefore, data analysis is not possible.
Time to discharge from treatment, measured by EHR review.
Outcome measures
| Measure |
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.
|
Treatment as Usual (TAU)
n=4 Participants
Treatment-as-usual administered at office-based buprenorphine treatment clinics.
|
|---|---|---|
|
Treatment Discharge
|
—
|
NA Days
Standard Deviation NA
Data collected on only 4 participants.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 12 weeks post-randomizationHaving one or more study urine drug tests negative for buprenorphine
Outcome measures
| Measure |
Video-based DOT Application
n=39 Participants
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 (TAU)
n=39 Participants
Treatment-as-usual administered at office-based buprenorphine treatment clinics.
|
|---|---|---|
|
Buprenorphine Non-use: One or More UDT Negative for Buprenorphine
|
7 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12 post-randomizationPopulation: 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.
Number of participants having a study urine drug test positive for stimulants (cocaine, amphetamines or methamphetamines).
Outcome measures
| Measure |
Video-based DOT Application
n=24 Participants
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 (TAU)
n=30 Participants
Treatment-as-usual administered at office-based buprenorphine treatment clinics.
|
|---|---|---|
|
UDT Positive for Stimulants at Week 12
|
7 Participants
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12 post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
Video-based DOT Application
n=24 Participants
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 (TAU)
n=30 Participants
Treatment-as-usual administered at office-based buprenorphine treatment clinics.
|
|---|---|---|
|
Treatment Satisfaction
|
4.6 score on a scale
Standard Deviation 0.6
|
4.6 score on a scale
Standard Deviation 0.5
|
Adverse Events
Video-based DOT Application
Serious events: 9 serious events
Other events: 3 other events
Deaths: 1 deaths
Treatment as Usual (TAU)
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Video-based DOT Application
n=39 participants at risk
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 (TAU)
n=39 participants at risk
Treatment-as-usual administered at office-based buprenorphine treatment clinics.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
In-patient hospitalization
|
2.6%
1/39 • Number of events 1 • Up to 24 weeks.
|
0.00%
0/39 • Up to 24 weeks.
|
|
Psychiatric disorders
In-patient hospitalization
|
10.3%
4/39 • Number of events 4 • Up to 24 weeks.
|
5.1%
2/39 • Number of events 2 • Up to 24 weeks.
|
|
Infections and infestations
In-patient hospitalization
|
2.6%
1/39 • Number of events 1 • Up to 24 weeks.
|
0.00%
0/39 • Up to 24 weeks.
|
|
Cardiac disorders
In-patient hospitalization
|
2.6%
1/39 • Number of events 1 • Up to 24 weeks.
|
2.6%
1/39 • Number of events 1 • Up to 24 weeks.
|
|
Injury, poisoning and procedural complications
In-patient hospitalization
|
2.6%
1/39 • Number of events 1 • Up to 24 weeks.
|
0.00%
0/39 • Up to 24 weeks.
|
|
General disorders
In-patient hospitalization
|
2.6%
1/39 • Number of events 1 • Up to 24 weeks.
|
0.00%
0/39 • Up to 24 weeks.
|
Other adverse events
| Measure |
Video-based DOT Application
n=39 participants at risk
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 (TAU)
n=39 participants at risk
Treatment-as-usual administered at office-based buprenorphine treatment clinics.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea from medicine
|
0.00%
0/39 • Up to 24 weeks.
|
2.6%
1/39 • Number of events 1 • Up to 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain - lower extremities
|
2.6%
1/39 • Number of events 1 • Up to 24 weeks.
|
0.00%
0/39 • Up to 24 weeks.
|
|
General disorders
Generall Illness
|
5.1%
2/39 • Number of events 2 • Up to 24 weeks.
|
0.00%
0/39 • Up to 24 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place