Opioid Use DisorderPhase 2ROME IINCT06338280
Remotely Observed Methadone Evaluation II
A Phase 2 study testing Sonara in people with Opioid Use Disorder, run by Sonara Health at 1 site in United States.
Trial summary
Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Sonara
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Dec 2024to 30 Apr 2027
- Phase
- Phase 2
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Willing to participate in a randomized trial
- Able to complete study instruments and interviews
Who cannot join
- Less than 18 years of age
- Pregnant or planning to be pregnant
- Currently involved in the criminal justice system
- Serious mental health problems
- Treated with buprenorphine
- Please note: The enrollment target (2.5 randomizations per week over 50 weeks) includes oversampling women and under-represented racial/ethnicity groups (i.e., at least 10 or more individuals per group who identify as Black, Hispanic, and American Indian/Alaskan Native).
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
FGC Wabash
Chicago, Illinois, 75220
Michael Dennis, PhD, 888-924-3786, mdennis@chestnut.org
About this study
Official title: Remote Observed Methadone Evaluation Phase II (ROME II): Retention and Costs of Care
Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs). Sonara Health designed a HIPAA-compliant web-application called Sonara that features integrated video dosing recording, a tamper-evident seal, and an innovative measurement-based care (MBC) framework called the Opioid Craving Visual Analogue Scale (OC-VAS) to facilitate methadone take-homes while providing evidence of appropriate use and monitoring patient outcomes. Phase II of this SBIR aims to compare Sonara against usual take-homes to assess its impact on retention in care, opioid use, patient outcomes, and costs of care.
- 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.
SonaraOther
Sonara virtual dosing window and engagement platform
| Study group | Role | What they receive |
|---|---|---|
| Sonara-enabled | Experimental | Not described Receives: Other: Sonara |
| Treatment as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Length of time the patient remains in treatment after study enrollment
Measured: 24 weeks
Take homes received over time
The number of take home doses of methadone received at 4-, 12-, and 24-weeks following randomization
Measured: 24 weeks
Secondary outcomes (5)
Opioid cravings
Opioid craving visual analog scale (OC-VAS), a single-item, patient-reported outcome measure that captures the severity of cravings, reported on a 0-100 scale
Measured: 24 weeks
Urine toxicology
A qualitative test that detects the presence of commonly used illicit substances or their metabolites in a urine sample
Measured: 24 weeks
Opioid withdrawal severity
Subjective Opioid Withdrawal Scale (SOWS) - a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely)
Measured: 24 weeks
Health-related quality of life
CDC (Health-related quality of life) HRQOL-14 "Healthy Days Measure" - 14-item questionnaire that assesses an individual's perceived physical and mental health status over the past 30 days, including self-rated health, recent days of poor physical or mental health, and activity limitations
Measured: 24 weeks
Drug Abuse Treatment Costs Analysis
A standardized method for estimating the economic costs of substance abuse treatment programs, including both direct costs (such as personnel, supplies, and facilities) and indirect costs (such as overhead and administrative expenses)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start24 Dec 2024
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonara Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chestnut Health Systems
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338280
- Sponsor's protocol ID
- VDW002
- Acronym
- ROME II
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Observed Methadone Evaluation Phase II (ROME II): Retention and Costs of Care
- ClinicalTrials.gov ID
- NCT06338280
- Acronym / sponsor ID
- ROME II / VDW002
- Conditions
- Opioid Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sonara HealthIndustry (pharma, biotech, devices)
- Collaborators
- Chestnut Health Systems
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 29 Mar 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.
Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs). Sonara Health designed a HIPAA-compliant web-application called Sonara that features integrated video dosing recording, a tamper-evident seal, and an innovative measurement-based care (MBC) framework called the Opioid Craving Visual Analogue Scale (OC-VAS) to facilitate methadone take-homes while providing evidence of appropriate use and monitoring patient outcomes. Phase II of this SBIR aims to compare Sonara against usual take-homes to assess its impact on retention in care, opioid use, patient outcomes, and costs of care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonara-enabled | Experimental | Other: Sonara |
| Treatment as usual | No intervention | – |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Willing to participate in a randomized trial
- Able to complete study instruments and interviews
Key exclusion criteria (6 listed)
- Less than 18 years of age
- Pregnant or planning to be pregnant
- Currently involved in the criminal justice system
- Serious mental health problems
- Treated with buprenorphine
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 |
|---|---|---|
| SonaraSonara virtual dosing window and engagement platform | Other | Sonara-enabled |
Primary outcome
Retention
Time frame: 24 weeks
Length of time the patient remains in treatment after study enrollment
Take homes received over time
Time frame: 24 weeks
The number of take home doses of methadone received at 4-, 12-, and 24-weeks following randomization
5 secondary outcomes
Opioid cravings
Time frame: 24 weeks
Urine toxicology
Time frame: 24 weeks
Opioid withdrawal severity
Time frame: 24 weeks
Health-related quality of life
Time frame: 24 weeks
Drug Abuse Treatment Costs Analysis
Time frame: 24 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 27 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 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 2 inclusion and 6 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 27 Mar 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 27 Mar 2026.