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Recruiting NCT07169409

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

Phase I Interventional Opioid Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Telemedicine Buprenorphine Treatment.
Who it may be relevant to
Registry conditions: Opioid Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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.

Primary outcome measures

  • Intervention Acceptability, Appropriateness, Feasibility [Time frame: 48 weeks]
Secondary outcome measures (3)
  • CDC's Health-Related Quality of Life - 4 (CDC HRQOL-4, also called the "Healthy Days Measures") [Time frame: 48 weeks]
  • Brief Addiction Monitor [Time frame: 48 weeks]
  • Visual Analogue Opioid Craving Scale [Time frame: 48 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Boulder Care — Portland

Publications

  • 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. PMID 28851459

Identifiers

NCT: NCT07169409 · 4R44DA061386 · 1R44DA061386-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗