Clinical trial NCT05529225: Evaluating the Efficacy of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder
Official title: Evaluating the Usability, Efficacy and Commercial Utility of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use Disorder
Keywords: Opioid Use Disorder
Telehealth
Retention in Care
Lead sponsor: Boulder Care
Sponsor class: INDUSTRY
Collaborators: name: Oregon Health and Science University
First posted: 2022-09-07
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People seeking buprenorphine treatment for opioid use disorder.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Retention in treatment
timeFrame: 48 weeks
Secondary outcomes:
measure: Participant satisfaction
timeFrame: 48 weeks
measure: Changes in cravings, health perception, and health care utilization
timeFrame: 48 weeks
measure: Changes in risk factors for substance use and for protective factors that support recovery
timeFrame: 48 weeks
measure: Changes in demographics i.e., employment, education, housing, etc
timeFrame: 48 weeks
Other outcomes:
measure: Evaluation of opioid use
timeFrame: 48 weeks
Locations:
city: Portland
country: United States
facility: Boulder Care
state: Oregon
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
Study officials:
affiliation: Boulder Care
name: Stephanie Strong
role: PRINCIPAL_INVESTIGATOR
References: