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

September 9, 2025 updated by: Boulder Care
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Receiving Intervention
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Acceptability, Appropriateness, Feasibility
Time Frame: 48 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
CDC's Health-Related Quality of Life - 4 (CDC HRQOL-4, also called the "Healthy Days Measures")
Time Frame: 48 weeks

Items include: self-rated health, physically unhealthy days, mentally unhealthy days, and activity limitation days.

Values:

Self-rated health: 1 = Excellent, 2 = Very good, 3 = Good, 4 = Fair, 5 = Poor → Minimum = 1 (Excellent), Maximum = 5 (Poor)

Unhealthy days (physical/mental): Range 0-30 days in past 30 days

→ Minimum = 0, Maximum = 30

Direction: Higher scores = worse outcomes (more unhealthy days or poorer self-rated health).
48 weeks
Brief Addiction Monitor
Time Frame: 48 weeks

Description: A 17-item multidimensional measure covering three domains:

  1. Risk factors (e.g., substance use, craving, triggers)
  2. Protective factors (e.g., social support, confidence in recovery)
  3. Recovery environment (e.g., housing, employment, stress)

Values:

  • Most items use a 0-30 day timeframe with counts (e.g. "How many days in the past 30 have you used alcohol?" → 0-30).
  • Some items use Likert-type 0-4 response options (e.g. "Not at all" to "Extremely").

Scoring and Direction:

  • Higher scores on "risk" items = worse outcomes (e.g., more days using substances, more craving, more risk exposure).
  • Higher scores on "protective" items = better outcomes (e.g., greater confidence, more supportive contacts).
48 weeks
Visual Analogue Opioid Craving Scale
Time Frame: 48 weeks

Description: A single-item measure where participants rate their current intensity of craving for opioids by marking a point along a straight line (100 mm in length). The left anchor indicates "No craving at all" and the right anchor indicates "Most intense craving imaginable".

Values:

Minimum = 0 mm (no craving at all) Maximum = 100 mm (most intense craving imaginable)

Direction: Higher scores = worse outcome (greater opioid craving)
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boulder Care

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Study Director: Andrea Baron, MPH, Boulder Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 15, 2027

Study Registration Dates

First Submitted

August 28, 2025

First Submitted That Met QC Criteria

September 9, 2025

First Posted (Estimated)

September 11, 2025

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4R44DA061386 (U.S. NIH Grant/Contract)
  • 1R44DA061386-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share individual participant data (IPD) from this study. Only aggregate study results will be reported.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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