Right Tools, Right Time, Right Place: Telehealth for Opioid Use Disorder in Vulnerable Settings

NCT07169409 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 4R44DA0613861R44DA061386-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Our primary objective is to evaluate the ability of Boulder Care's telehealth-platform to create the necessary paradigmatic shift in Opioid Use Disorder (OUD) treatment to reach vulnerable populations, with targets that support both equitable and culturally-specific OUD treatment as well as business profitability.

Conditions

Opioid Use Disorder

Keywords

telehealth

Outcome Measures

Primary Outcomes (1)

• Intervention Acceptability, Appropriateness, Feasibility

  To measure the participant intervention experience, the study team will utilize qualitative interview data with study participants. These data will be organized into the implementation science categories: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). The study team will determine whether each participant found the intervention to be feasible, acceptable, and/or appropriate. These findings will then be aggregated to better understand how participants experience the implementation of a telemedicine Opioid Use Disorder treatment organization, and will inform a future scaled-up implementation.

  48 weeks

Secondary Outcomes (3)

• CDC's Health-Related Quality of Life - 4 (CDC HRQOL-4, also called the "Healthy Days Measures")

  48 weeks

• Brief Addiction Monitor

  48 weeks

• Visual Analogue Opioid Craving Scale

  48 weeks

Study Arms (1)

Receiving Intervention

EXPERIMENTAL

Drug: Telemedicine Buprenorphine Treatment

Interventions

Telemedicine Buprenorphine Treatment DRUG

With this NIDA-funded grant, the study team will identify app-based treatment workflows that are demonstrably effective in low-resource settings: namely, telehealth services that are accessible without high-speed internet and deliberately helping patients transition into OUD care from relevant health and community system settings. An intentional focus on rural areas and Black and Hispanic demographics will help enhance health equity, and support solutions for payors.

Receiving Intervention

Eligibility Criteria

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

You may qualify if:

• History of Opioid Use Disorder (OUD)
• Starting OUD treatment with buprenorphine, or within 45 days of starting or restarting this medication
• Speak and understand English

You may not qualify if:

• History of allergic reaction to buprenorphine
• Plans to move out of a Boulder Care-affiliated state site in the next 12 months (precluding continuation of care)
• Untreated mental or medical health conditions that, in the opinion of the participant, would preclude study participation

Sponsors & Collaborators

• Boulder Care: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Boulder Care

Portland, Oregon, 97204, United States

RECRUITING

Related Publications (1)

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrea Baron, MPH

  Boulder Care

  STUDY DIRECTOR

Central Study Contacts

Andrea Baron, MPH

CONTACT

408-483-2766; andrea.baron@boulder.care

Laura Monico, PhD

CONTACT

855-605-8816; laura.monico@boulder.care

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 11, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)