Opioid Use DisorderPhase 1NCT07169409
Right Tools, Right Time, Right Place: Telehealth for Opioid Use Disorder in Vulnerable Settings
A Phase 1 study testing Telemedicine Buprenorphine Treatment in people with Opioid Use Disorder, run by Boulder Care at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Telemedicine Buprenorphine Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2025to 15 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boulder Care
Portland, Oregon, 97204
Andrea Baron, MPH, 4084832766, andrea.baron@boulder.care
Laura Monico, PhD, 855-605-8816, laura.monico@boulder.care
About this study
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.
- Conditions
- Opioid Use Disorder
- Being tested
- Telemedicine Buprenorphine Treatment
- Keywords
- telehealth
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine Buprenorphine TreatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Receiving Intervention | Experimental | Not described Receives: Drug: Telemedicine Buprenorphine Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability, Appropriateness, Feasibility
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.
Measured: 48 weeks
Secondary outcomes (3)
CDC's Health-Related Quality of Life - 4 (CDC HRQOL-4, also called the "Healthy Days Measures")
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).
Measured: 48 weeks
Brief Addiction Monitor
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).
Measured: 48 weeks
Visual Analogue Opioid Craving Scale
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)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start10 Jun 2025
- Primary completionAug 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boulder Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Andrea Baron, MPH, Study director, Boulder Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169409
- Sponsor's protocol ID
- 4R44DA061386
- Other IDs
- 1R44DA061386-01
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data (IPD) from this study. Only aggregate study results will be reported.
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.
PubMed 28851459
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Tools, Right Time, Right Place: Telehealth for Opioid Use Disorder in Vulnerable Settings
- ClinicalTrials.gov ID
- NCT07169409
- Acronym / sponsor ID
- 4R44DA061386
- Conditions
- Opioid Use Disorder
- Keywords
- telehealth
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Boulder CareIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiving Intervention | Experimental | Drug: Telemedicine Buprenorphine Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine Buprenorphine TreatmentWith 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. | Drug | Receiving Intervention |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Background: PubMed 28851459Weiner 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.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data (IPD) from this study. Only aggregate study results will be reported.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Baron, MPH study director
Boulder Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telemedicine Buprenorphine Treatment in people with Opioid Use Disorder, run by Boulder Care at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Baron, MPH (408-483-2766, andrea.baron@boulder.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Acceptability, Appropriateness, Feasibility (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07169409, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.