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OpenTrials
Recruiting

NCT Number: NCT07169409

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. Brief Addiction Monitor

    Time frame: 48 weeks

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

    • Risk factors (e.g., substance use, craving, triggers)
    • Protective factors (e.g., social support, confidence in recovery)
    • 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).
  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Baron, MPH

CONTACT

[email protected]

408-483-2766

Laura Monico, PhD

CONTACT

[email protected]

855-605-8816

Sponsors and collaborators

Lead sponsor

Boulder Care

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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