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

NCT07169409
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
250
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Lead sponsor
Boulder Care
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Start date
2025-06-10
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Number of sites
1
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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.
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Short title
Right Tools, Right Time, Right Place: Telehealth for Opioid Use Disorder in Vulnerable Settings
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Official title
Right Tools, Right Time, Right Place: Telehealth for Opioid Use Disorder in Vulnerable Settings
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-09-15
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First posted
2025-09-11
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Registry last updated
2025-09-11
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Primary completion date
2027-08-01
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Start date
2025-06-10
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Participants
250
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Participant count basis
Estimated
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Planned participants
250
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Boulder Care
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07169409
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ClinicalTrials.gov ID
NCT07169409
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Intervention Acceptability, Appropriateness, Feasibility

    Timeframe: 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.

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

    Timeframe: 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

    Timeframe: 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).

  3. Visual Analogue Opioid Craving Scale

    Timeframe: 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)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
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  • Boulder CarePortland, United StatesRecruiting
Sources for sites
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Other registry identifiers

  • 1R44DA061386-01
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Targets (2)