Opioid Use DisorderBEaTSNCT05529225
Evaluating the Efficacy of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder
An observational study of Opioid Use Disorder, run by Boulder Care at 2 sites in United States.
Trial summary
Buprenorphine Evaluation and Telehealth Study (BEaTS) Comparison of retention in care between telehealth-based care and treatment as usual. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- How many people
- 159 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2021to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People seeking buprenorphine treatment for opioid use disorder.
Who may be able to join
- 18 years of age or older with a diagnosis of OUD
- Within 45 days of seeking buprenorphine prescription
- Have a working smartphone
- Speaks and understands English
Who cannot join
- Untreated mental or medical health conditions that, in the opinion of the patient, would preclude study participation
- History of allergic reaction to buprenorphine
- Impending incarceration
- Plans to move out of Oregon in next 12 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boulder Care
Portland, Oregon, 97204
Oregon Health Sciences University
Portland, Oregon, 97239-3098
About this study
Official title: Evaluating the Usability, Efficacy and Commercial Utility of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder
Buprenorphine Evaluation and Telehealth Study (BEaTS)
Comparison of retention in care between telehealth-based care and treatment as usual.
Read the detailed description
Evaluating the Usability, Efficacy and Commercial Utility of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder
Phase I, Aim I: Completed (R44 DA050354). Advance Boulder Care's mobile platform development and obtain usability feedback from individuals with prior OUD treatment. Aim 1 was successfully completed during Phase I, meeting milestones for improving product usability and satisfaction while reducing treatment barriers.
Phase II, Aim 2: Compare study participants who enroll in Boulder Care (n = 100) to participants who enroll in treatment as usual (i.e., office-based buprenorphine) (n = 100) and assess buprenorphine retention at 48 weeks (primary outcome) and monitor a) transition from referral to treatment, b) care continuity, c) engagement in care, and d) satisfaction with care (secondary outcomes).
Phase II, Aim 3: Compare study participants who enroll in Boulder Care (n = 100) to participants who enroll in treatment as usual (i.e., office-based buprenorphine) (n = 100) and assess at baseline, 4, 12, 24, 36, and 48 weeks post treatment initiation opioid use (primary outcome) and monitor employment, housing stability, and criminal justice involvement (secondary outcomes).
Phase II Approach.
The COVID-19 pandemic has altered treatment and research for OUD. Phase II of the Small Business Innovation Research (SBIR) award "Evaluating the usability, feasibility and commercial utility of a digital platform to deliver comprehensive treatment for opioid use disorder" (R44 DA050354) takes advantage of further development of the Boulder Care platform and expands the testing of our digitally-delivered treatment.
To assure the quality and success of the Phase II award, a partnership with experienced National Institute on Drug Abuse (NIDA) investigators under the leadership of Todd Korthuis, MD, MPH, strengthens the application. The application is modified to take advantage of Dr. Korthuis' and his team's experience and access to the Oregon Health \& Science University (OHSU) Harm Reduction and Bridges to Recovery clinic (HRBR - pronounced "harbor") and buprenorphine prescribing at OHSU primary care clinics. The HRBR clinic offers low-barrier buprenorphine initiation and stabilization, linking patients to community providers for ongoing care. The clinic can provide referrals to facilitate recruitment to Boulder Care services and participation in the Phase II study.
- Conditions
- Opioid Use Disorder
- Keywords
- Opioid Use Disorder, Telehealth, Retention in Care
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Boulder Care | People seeking buprenorphine for opioid use disorder via telehealth. | |
| OHSU | People seeking buprenorphine for opioid use disorder via treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in treatment
The primary Goal of the Phase II project is to compare participant retention in buprenorphine treatment for opioid use disorder (OUD) at 48 weeks for participants enrolled in Boulder Care (n=l00) to participants enrolled in treatment-as-usual (TAU) from OHSU (Oregon Health \& Science University) clinics (n=100).
Retention in treatment will be assessed through the Electronic Medical Record for each patient and whether there is an active buprenorphine prescription for the patient at 48 weeks of care. Because of the protocols for each clinic, such a prescription will indicate that treatment is active for a given participant.
This is the most direct way to assess ongoing buprenorphine treatment as Oregon law prohibits use of its Prescription Drug Monitoring Program for research.
Measured: 48 weeks
Secondary outcomes (4)
Participant satisfaction
Participant satisfaction with telehealth comparing Boulder Care's fully digital integrated platform to OHSU's TAU approach which uses in-person treatment as well as ad-hoc telehealth due to the COVID-19 pandemic.
Assessment at baseline and weeks 4, 12, 24, 36 and 48 after enrollment in the study.
Patient satisfaction with treatment is assessed via a single-item: "How satisfied are you with your buprenorphine treatment?" with 5-point Likert scale (very dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, very satisfied) adapted from treatment satisfaction measures used in the National Drug Abuse Treatment Clinical Trials Network studies.
Measured: 48 weeks
Changes in cravings, health perception, and health care utilization
Changes in cravings, health perception, and health care utilization.
Assessment at baseline and weeks 4, 12, 24, 36 and 48 after enrollment in the study.
Degree of craving will be assessed with the 17-item Brief Addiction Monitor (BAM) and the 4-item Treatment Effectiveness Assessment (TEA). Health perception will be assessed with the CDC's health-related quality of life (HRQoL) instrument. Health care utilization will be assessed from the medical record and patient report.
Measured: 48 weeks
Changes in risk factors for substance use and for protective factors that support recovery
Changes in risk factors for substance use and for protective factors that support recovery.
Assessment at baseline and weeks 4, 12, 24, 36 and 48 after enrollment in the study.
The 17-item Brief Addiction Monitor (BAM) and the 4-item Treatment Effectiveness Assessment (TEA) will be used to evaluate these risk and protective factors.
Measured: 48 weeks
Changes in demographics i.e., employment, education, housing, etc
Changes in demographics i.e., employment, education, housing, etc.
Assessment at baseline and weeks 4, 12, 24, 36 and 48 after enrollment in the study.
We assess functional outcome measures using the 17-item Brief Addiction Monitor (BAM), and the 4-item Treatment Effectiveness Assessment (TEA). These instruments incorporate patient-centered functional measures of recovery such as relationships, employment, spiritual comfort, and achievement of self-identified treatment goals in addition to assessments of drug use.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Apr 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boulder Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Stephanie Strong, Principal investigator, Boulder Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529225
- Sponsor's protocol ID
- 1R44DA050354-02
- Acronym
- BEaTS
- Status last verified
- Feb 2023
- First submitted
- 28 Jun 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Usability, Efficacy and Commercial Utility of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05529225
- Acronym / sponsor ID
- BEaTS / 1R44DA050354-02
- Conditions
- Opioid Use Disorder
- Keywords
- Opioid Use Disorder, Telehealth, Retention in Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Boulder CareIndustry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Buprenorphine Evaluation and Telehealth Study (BEaTS)
Comparison of retention in care between telehealth-based care and treatment as usual.
Detailed description
Evaluating the Usability, Efficacy and Commercial Utility of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder
Phase I, Aim I: Completed (R44 DA050354). Advance Boulder Care's mobile platform development and obtain usability feedback from individuals with prior OUD treatment. Aim 1 was successfully completed during Phase I, meeting milestones for improving product usability and satisfaction while reducing treatment barriers.
Phase II, Aim 2: Compare study participants who enroll in Boulder Care (n = 100) to participants who enroll in treatment as usual (i.e., office-based buprenorphine) (n = 100) and assess buprenorphine retention at 48 weeks (primary outcome) and monitor a) transition from referral to treatment, b) care continuity, c) engagement in care, and d) satisfaction with care (secondary outcomes).
Phase II, Aim 3: Compare study participants who enroll in Boulder Care (n = 100) to participants who enroll in treatment as usual (i.e., office-based buprenorphine) (n = 100) and assess at baseline, 4, 12, 24, 36, and 48 weeks post treatment initiation opioid use (primary outcome) and monitor employment, housing stability, and criminal justice involvement (secondary outcomes).
Phase II Approach.
The COVID-19 pandemic has altered treatment and research for OUD. Phase II of the Small Business Innovation Research (SBIR) award "Evaluating the usability, feasibility and commercial utility of a digital platform to deliver comprehensive treatment for opioid use disorder" (R44 DA050354) takes advantage of further development of the Boulder Care platform and expands the testing of our digitally-delivered treatment.
To assure the quality and success of the Phase II award, a partnership with experienced National Institute on Drug Abuse (NIDA) investigators under the leadership of Todd Korthuis, MD, MPH, strengthens the application. The application is modified to take advantage of Dr. Korthuis' and his team's experience and access to the Oregon Health \& Science University (OHSU) Harm Reduction and Bridges to Recovery clinic (HRBR - pronounced "harbor") and buprenorphine prescribing at OHSU primary care clinics. The HRBR clinic offers low-barrier buprenorphine initiation and stabilization, linking patients to community providers for ongoing care. The clinic can provide referrals to facilitate recruitment to Boulder Care services and participation in the Phase II study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boulder Care | – | –People seeking buprenorphine for opioid use disorder via telehealth. |
| OHSU | – | –People seeking buprenorphine for opioid use disorder via treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People seeking buprenorphine treatment for opioid use disorder.
Key inclusion criteria (4 listed)
- 18 years of age or older with a diagnosis of OUD
- Within 45 days of seeking buprenorphine prescription
- Have a working smartphone
- Speaks and understands English
Key exclusion criteria (4 listed)
- Untreated mental or medical health conditions that, in the opinion of the patient, would preclude study participation
- History of allergic reaction to buprenorphine
- Impending incarceration
- Plans to move out of Oregon in next 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retention in treatment
Time frame: 48 weeks
The primary Goal of the Phase II project is to compare participant retention in buprenorphine treatment for opioid use disorder (OUD) at 48 weeks for participants enrolled in Boulder Care (n=l00) to participants enrolled in treatment-as-usual (TAU) from OHSU (Oregon Health \& Science University) clinics (n=100). Retention in treatment will be assessed through the Electronic Medical Record for each patient and whether there is an active buprenorphine prescription for the patient at 48 weeks of care. Because of the protocols for each clinic, such a prescription will indicate that treatment is active for a given participant. This is the most direct way to assess ongoing buprenorphine treatment as Oregon law prohibits use of its Prescription Drug Monitoring Program for research.
4 secondary outcomes
Participant satisfaction
Time frame: 48 weeks
Changes in cravings, health perception, and health care utilization
Time frame: 48 weeks
Changes in risk factors for substance use and for protective factors that support recovery
Time frame: 48 weeks
Changes in demographics i.e., employment, education, housing, etc
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Strong principal investigator
Boulder Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder, run by Boulder Care at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in treatment (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.