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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07169409
Enrollment
250
Registered
2025-09-11
Start date
2025-06-10
Completion date
2027-09-15
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use Disorder

Keywords

telehealth

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.

Interventions

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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Boulder Care
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intervention Acceptability, Appropriateness, Feasibility48 weeksTo 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

MeasureTime frameDescription
CDC's Health-Related Quality of Life - 4 (CDC HRQOL-4, also called the Healthy Days Measures)48 weeksItems 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).
Brief Addiction Monitor48 weeksDescription: 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).
Visual Analogue Opioid Craving Scale48 weeksDescription: 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)

Countries

United States

Contacts

Primary ContactAndrea Baron, MPH
andrea.baron@boulder.care408-483-2766
Backup ContactLaura Monico, PhD
laura.monico@boulder.care855-605-8816

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026