Opioid Use DisorderROMENCT06200740
Remotely Observed Methadone Evaluation
A study testing Sonara in people with Opioid Use Disorder, run by Sonara Health at 1 site in United States.
Trial summary
Opioid addiction, which affects 16 million individuals worldwide, can be treated using methadone, a proven and effective opioid medication for treating OUD that extends retention in care, reduces mortality, and inhibits illicit drug use. 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?
- Sonara
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2022to 2 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Receiving methadone for the treatment of opioid use disorder
Who cannot join
- Patients with >13 take-homes
- Patients with positive toxicology results in last 30-60 days
- Patients involved with drug court ineligible for take-homes
- Patients without adequate access to technology
- Patients with <30 days in treatment
- Patients with mental health instability
Show all 9Show fewer
- Patients with recent diversion attempts
- Patients using buprenorphine for agonist therapy
- Patients guest dosing at another clinic during trial period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remotely Observed Methadone Evaluation (ROME)
Opioid addiction, which affects 16 million individuals worldwide, can be treated using methadone, a proven and effective opioid medication for treating OUD that extends retention in care, reduces mortality, and inhibits illicit drug use. However, methadone treatment is limited to federally certified Opioid Treatment Programs (OTPs), which must meet complex regulatory requirements, and require new patients to take their dose in person six days per week, presenting significant barriers to treatment. To address these barriers, Sonara Heath has developed the Sonara software platform, which will enable OTPs to offer accelerated take-home methadone regimens while maintaining safety and diversion prevention.
- Conditions
- Opioid Use Disorder
- Being tested
- Sonara
- 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.
SonaraDevice
Also called Elpida, Virtual dosing window
web application facilitating asynchronous observation of methadone dosing
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale (SUS)
The SUS, a 10-item scale with each item rated on a 5-point scale (scored 0 to 4) with five negative statements (e.g., system is unnecessarily complex) (reverse scored) and five positive statements (e.g., system functions are well integrated), evaluated user perceptions of the system's usability. We summed scores and multiplied them by 2.5 for the total score with a range from 0 to 100 (Lewis, 2018).
Measured: two weeks
Secondary outcomes (1)
Acceptability, Appropriateness and Feasibility of Implementation Measures
Acceptability Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) are single factor 4-item scales scored 1 to 5 and summed with test-retest reliabilities of 0.73 to 0.88 (Weiner et al., 2017). Scores for each of the three dimensions have a potential range of 4 to 20 with higher scores suggesting better implementation potential.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start25 Sep 2022
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonara Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University, Stanford University, Adapt Oregon
- Responsible party
- Principal investigator, Michael Giles, Sonara Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200740
- Sponsor's protocol ID
- VDW001
- Other IDs
- R43DA056259
- Acronym
- ROME
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Observed Methadone Evaluation (ROME)
- ClinicalTrials.gov ID
- NCT06200740
- Acronym / sponsor ID
- ROME / VDW001
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sonara HealthIndustry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University, Stanford University, Adapt Oregon
- Study start
- 25 Sep 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 11 Jan 2024 (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.
Opioid addiction, which affects 16 million individuals worldwide, can be treated using methadone, a proven and effective opioid medication for treating OUD that extends retention in care, reduces mortality, and inhibits illicit drug use. However, methadone treatment is limited to federally certified Opioid Treatment Programs (OTPs), which must meet complex regulatory requirements, and require new patients to take their dose in person six days per week, presenting significant barriers to treatment. To address these barriers, Sonara Heath has developed the Sonara software platform, which will enable OTPs to offer accelerated take-home methadone regimens while maintaining safety and diversion prevention.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Receiving methadone for the treatment of opioid use disorder
Key exclusion criteria (9 listed)
- Patients with >13 take-homes
- Patients with positive toxicology results in last 30-60 days
- Patients involved with drug court ineligible for take-homes
- Patients without adequate access to technology
- Patients with <30 days in treatment
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 |
|---|---|---|
| SonaraAlso: Elpida, Virtual dosing windowweb application facilitating asynchronous observation of methadone dosing | Device | – |
Primary outcome
System Usability Scale (SUS)
Time frame: two weeks
The SUS, a 10-item scale with each item rated on a 5-point scale (scored 0 to 4) with five negative statements (e.g., system is unnecessarily complex) (reverse scored) and five positive statements (e.g., system functions are well integrated), evaluated user perceptions of the system's usability. We summed scores and multiplied them by 2.5 for the total score with a range from 0 to 100 (Lewis, 2018).
1 secondary outcome
Acceptability, Appropriateness and Feasibility of Implementation Measures
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonara in people with Opioid Use Disorder, run by Sonara Health 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 11 Jan 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2024.