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

NCT ID: NCT07169409

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-10

Study Completion Date

2027-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Receiving Intervention

Group Type EXPERIMENTAL

Telemedicine Buprenorphine Treatment

Intervention Type 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.

Interventions

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Telemedicine Buprenorphine Treatment

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Boulder Care

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Baron, MPH

Role: STUDY_DIRECTOR

Boulder Care

Locations

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Boulder Care

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrea Baron, MPH

Role: CONTACT

408-483-2766

Laura Monico, PhD

Role: CONTACT

855-605-8816

Facility Contacts

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Andrea Baron, MPH

Role: primary

4084832766

Laura Monico, PhD

Role: backup

855-605-8816

References

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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.

Reference Type BACKGROUND
PMID: 28851459 (View on PubMed)

Other Identifiers

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1R44DA061386-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4R44DA061386

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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