Evaluating the Efficacy of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder

NCT05529225 | Completed

• 1 other identifier: 1R44DA050354-02
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 2

Brief Summary

Buprenorphine Evaluation and Telehealth Study (BEaTS) Comparison of retention in care between telehealth-based care and treatment as usual.

Conditions

Opioid Use Disorder

Keywords

Opioid Use Disorder; Telehealth; Retention in Care

Outcome Measures

Primary Outcomes (1)

• 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.

  48 weeks

Secondary Outcomes (4)

• Participant satisfaction

  48 weeks

• Changes in cravings, health perception, and health care utilization

  48 weeks

• Changes in risk factors for substance use and for protective factors that support recovery

  48 weeks

• Changes in demographics i.e., employment, education, housing, etc

  48 weeks

Other Outcomes (1)

• Evaluation of opioid use

  48 weeks

Study Arms (2)

Boulder Care

People seeking buprenorphine for opioid use disorder via telehealth.

OHSU

People seeking buprenorphine for opioid use disorder via treatment as usual.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People seeking buprenorphine treatment for opioid use disorder.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boulder Care: lead
• Oregon Health and Science University: collaborator

Study Sites (2)

Boulder Care

Portland, Oregon, 97204, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Stephanie Strong

  Boulder Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: September 7, 2022
• Study Start: April 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)