Opioid-Related Disorders
Conditions
Keywords
Buprenorphine, Directly Observed Therapy, mHealth, Opioid Abuse
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.
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.
Interventions
BEHAVIORALVideo-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.
Sponsors
National Institute on Drug Abuse (NIDA)
emocha Mobile Health, Inc.
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Consecutive Weeks Opioid Negative Urine Tests | Baseline to 12 weeks post-randomization | The number of consecutive weeks with urine drug test negative for opioids. |
| 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. |
| 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. |
| 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). |
| 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 |
| 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. |
| Treatment Discharge | Baseline to 24 weeks post-randomization | Time to discharge from treatment, measured by EHR review. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 39 |
| Treatment as Usual (TAU) Office-based buprenorphine treatment | 39 |
| Total | 78 |
Baseline characteristics
| Characteristic | Video-based DOT Application | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 11.9 | 40.7 years STANDARD_DEVIATION 12 | 41.7 years STANDARD_DEVIATION 11.9 |
| Education College degree | 9 Participants | 4 Participants | 13 Participants |
| Education High school diploma/GED | 13 Participants | 20 Participants | 33 Participants |
| Education Less than a high school diploma | 7 Participants | 6 Participants | 13 Participants |
| Education Postgraduate | 1 Participants | 0 Participants | 1 Participants |
| Education Some post-high school | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 30 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Homelessness Homeless | 15 Participants | 16 Participants | 31 Participants |
| Homelessness Not homeless | 24 Participants | 23 Participants | 47 Participants |
| Prior Buprenorphine Treatment No | 15 Participants | 19 Participants | 34 Participants |
| Prior Buprenorphine Treatment Yes | 24 Participants | 20 Participants | 44 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 9 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 23 Participants | 25 Participants | 48 Participants |
| Region of Enrollment United States | 39 participants | 39 participants | 78 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 29 Participants | 29 Participants | 58 Participants |
| Study Site Boston | 20 Participants | 20 Participants | 40 Participants |
| Study Site Seattle | 19 Participants | 19 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 39 | 0 / 39 |
| other Total, other adverse events | 3 / 39 | 1 / 39 |
| serious Total, serious adverse events | 9 / 39 | 3 / 39 |
Outcome results
Primary
Percentage Opioid Negative Urine Tests
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
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Video-based DOT Application | Percentage Opioid Negative Urine Tests | 234 urine drug tests |
| Treatment as Usual (TAU) | Percentage Opioid Negative Urine Tests | 299 urine drug tests |
Comparison: 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.p-value: 0.0795% CI: [0.6, 1.02]Log-linear GEE regression
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.
Time frame: Week 12 post-randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video-based DOT Application | Percentage of Participants Engaged in Treatment at Week 12 | 27 Participants |
| Treatment as Usual (TAU) | Percentage of Participants Engaged in Treatment at Week 12 | 32 Participants |
Comparison: Null hypothesis: no difference between treatment arms in the percentage of patients engaged in treatment at week 12. TAU is the reference group.p-value: 0.295% CI: [0.65, 1.1]Poisson regression with robust SEs
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.
Time frame: Baseline to 12 weeks post-randomization
Population: Missing days are excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video-based DOT Application | Buprenorphine Adherence Self-Report | 5.99 days | Standard Deviation 2.18 |
| Treatment as Usual (TAU) | Buprenorphine Adherence Self-Report | 5.93 days | Standard Deviation 2.1 |
Comparison: Null hypothesis: No difference between arms in the mean number of days adherent to buprenorphine by self-report.p-value: 0.8895% CI: [0.89, 1.15]GEE Poisson regression
Other Pre-specified
Buprenorphine Non-use: One or More UDT Negative for Buprenorphine
Having one or more study urine drug tests negative for buprenorphine
Time frame: Baseline to 12 weeks post-randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video-based DOT Application | Buprenorphine Non-use: One or More UDT Negative for Buprenorphine | 7 Participants |
| Treatment as Usual (TAU) | Buprenorphine Non-use: One or More UDT Negative for Buprenorphine | 6 Participants |
Comparison: Null hypothesis: No difference between arms in number of participants who had one or more urine drug tests negative for buprenorphine.p-value: 0.7795% CI: [0.42, 3.24]Poisson regression with robust SEs
Other Pre-specified
Consecutive Weeks Opioid Negative Urine Tests
The number of consecutive weeks with urine drug test negative for opioids.
Time frame: Baseline to 12 weeks post-randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video-based DOT Application | Consecutive Weeks Opioid Negative Urine Tests | 4.8 weeks | Standard Deviation 4.2 |
| Treatment as Usual (TAU) | Consecutive Weeks Opioid Negative Urine Tests | 5.7 weeks | Standard Deviation 3.7 |
Comparison: Null hypothesis: No difference between arms on the number of consecutive weeks with UDT negative for opioids.p-value: 0.3195% CI: [-0.9, 2.7]t-test, 2 sided
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.
Time frame: Week 12 post-randomization
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video-based DOT Application | Number of Participants With Self-report of Opioid Use | 4 Participants |
| Treatment as Usual (TAU) | Number of Participants With Self-report of Opioid Use | 7 Participants |
Comparison: Null hypothesis: No difference between arms in the number of participants who self-reported illicit opioid use at week 12.p-value: 0.5795% CI: [0.23, 2.26]Poisson regression with robust SEs
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.
Time frame: Week 24 post-randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video-based DOT Application | Percentage of Participants Engaged in Treatment at Week 24 | 16 Participants |
| Treatment as Usual (TAU) | Percentage of Participants Engaged in Treatment at Week 24 | 22 Participants |
Comparison: Null hypothesis: No difference between arms in the percentage of participants engaged in treatment at week 24 post-randomization. TAU is the reference group.p-value: 0.1895% CI: [0.45, 1.16]Poisson regression with robust SEs
Other Pre-specified
Treatment Discharge
Time to discharge from treatment, measured by EHR review.
Time frame: Baseline to 24 weeks post-randomization
Population: Data was not avaiable on video-based DOT application participants. Therefore, data analysis is not possible.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment as Usual (TAU) | Treatment Discharge | NA Days |
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.
Time frame: Week 12 post-randomization
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video-based DOT Application | Treatment Satisfaction | 4.6 score on a scale | Standard Deviation 0.6 |
| Treatment as Usual (TAU) | Treatment Satisfaction | 4.6 score on a scale | Standard Deviation 0.5 |
Comparison: Null hypothesis: No difference between arms in mean treatment satisfaction scoresp-value: 0.9195% CI: [-0.29, 0.32]t-test, 2 sided
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).
Time frame: Week 12 post-randomization
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video-based DOT Application | UDT Positive for Stimulants at Week 12 | 7 Participants |
| Treatment as Usual (TAU) | UDT Positive for Stimulants at Week 12 | 13 Participants |
Comparison: Null hypothesis: No difference between arms in number of participants who tested positive for stimulants at week 12.p-value: 0.395% CI: [0.32, 1.43]Poisson regression with robust SEs