NCT03779997

Trial of Adherence App for Buprenorphine Treatment (TAAB) Study

Completed NA Results posted Last updated 6 October 2021

What this trial tests

NA trial testing Video-based DOT Application in Opioid-Related Disorders in 78 participants. Completed in 29 July 2020.

Timeline

15 February 2019

Primary endpoint
15 May 2020

29 July 2020

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	78
Start date	15 February 2019
Primary completion	15 May 2020
Estimated completion	29 July 2020
Sites	2 locations across United States

Drugs / interventions tested

• Video-based DOT Application

Conditions studied

• Opioid-Related Disorders — all drugs for Opioid-Related Disorders →

Sponsor

University of Washington

Who can join

18 and older, any sex, with Opioid-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage Opioid Negative Urine Tests Primary · Baseline to 12 weeks post-randomization

Percentage of weekly study urine drug tests that are negative for opioids, missing assumed to be positive.

Group	Value	95% CI
Video-based DOT Application	234
Treatment as Usual (TAU)	299

Percentage of Participants Engaged in Treatment at Week 12 Secondary · 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.

Group	Value	95% CI
Video-based DOT Application	27
Treatment as Usual (TAU)	32

Percentage of Participants Engaged in Treatment at Week 24 Secondary · Week 24 post-randomization

The percentage of participants engaged in treatment at 24 weeks post-randomization, measured by EHR review.

Group	Value	95% CI
Video-based DOT Application	16
Treatment as Usual (TAU)	22

Consecutive Weeks Opioid Negative Urine Tests Secondary · Baseline to 12 weeks post-randomization

The number of consecutive weeks with urine drug test negative for opioids.

Group	Value	95% CI
Video-based DOT Application	4.8	± 4.2
Treatment as Usual (TAU)	5.7	± 3.7

Number of Participants With Self-report of Opioid Use Secondary · Week 12 post-randomization

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

Group	Value	95% CI
Video-based DOT Application	4
Treatment as Usual (TAU)	7

Buprenorphine Adherence Self-Report Secondary · 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.

Group	Value	95% CI
Video-based DOT Application	5.99	± 2.18
Treatment as Usual (TAU)	5.93	± 2.10

Treatment Discharge Secondary · Baseline to 24 weeks post-randomization

Time to discharge from treatment, measured by EHR review.

Group	Value	95% CI
Treatment as Usual (TAU)	NA	± NA

Buprenorphine Non-use: One or More UDT Negative for Buprenorphine Secondary · Baseline to 12 weeks post-randomization

Having one or more study urine drug tests negative for buprenorphine

Group	Value	95% CI
Video-based DOT Application	7
Treatment as Usual (TAU)	6

UDT Positive for Stimulants at Week 12 Secondary · Week 12 post-randomization

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

Group	Value	95% CI
Video-based DOT Application	7
Treatment as Usual (TAU)	13

Treatment Satisfaction Secondary · 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.

Group	Value	95% CI
Video-based DOT Application	4.6	± 0.6
Treatment as Usual (TAU)	4.6	± 0.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 24 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Video-based DOT Application

Serious: 9/39 (23%)

Deaths: 1/39

Treatment as Usual (TAU)

Serious: 3/39 (8%)

Deaths: 0/39

Serious adverse events (6 terms)

Reaction	System	Video-based DOT Application	Treatment as Usual (TAU)
In-patient hospitalization	Psychiatric disorders	—	—
In-patient hospitalization	Skin and subcutaneous tissue disorders	—	—
In-patient hospitalization	Infections and infestations	—	—
In-patient hospitalization	Cardiac disorders	—	—
In-patient hospitalization	Injury, poisoning and procedural complications	—	—
In-patient hospitalization	General disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Video-based DOT Application	Treatment as Usual (TAU)
Generall Illness	General disorders	—	—
Nausea from medicine	Gastrointestinal disorders	—	—
Pain - lower extremities	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: In-patient hospitalization, In-patient hospitalization, In-patient hospitalization, In-patient hospitalization, In-patient hospitalization, In-patient hospitalization.

Data from ClinicalTrials.gov NCT03779997 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Video directly observed therapy for patients receiving office-based buprenorphine - A pilot randomized controlled trial.
   Tsui JI, Leroux BG, Radick AC, Schramm ZA, et al · · 2021 · cited 15× · PMID 34399136 · DOI 10.1016/j.drugalcdep.2021.108917
2. 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.
   Schramm ZA, Leroux BG, Radick AC, Ventura AS, et al · · 2020 · cited 14× · PMID 32736660 · DOI 10.1186/s13722-020-00203-9
3. Use of Video Directly Observed Therapy and Characteristics Associated With Use Among Patients Treated With Buprenorphine in an Office-based Setting.
   Radick AC, James J, Leroux BG, Kim TW, et al · · 2023 · PMID 37267172 · DOI 10.1097/adm.0000000000001103