Sonara for Opioid Use Disorder

(ROME II Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sonara Health

Must be taking: Methadone

Must not be taking: Buprenorphine

Disqualifiers: Under 18, Pregnant, Criminal justice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called Sonara, designed to assist individuals with severe opioid use disorder (OUD) in using methadone more conveniently. Methadone is effective but often requires daily clinic visits, which can be challenging. Sonara employs video dosing and monitoring, enabling individuals to take methadone at home while ensuring proper use. The trial compares Sonara to the traditional method of taking home methadone to determine if it aids in treatment retention and improves outcomes. Prospective participants should be willing to join a randomized trial and capable of completing study instruments and interviews. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those treated with buprenorphine. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that the Sonara web-application is safe for use in opioid use disorder treatment?

Research has shown that the Sonara web app is generally safe for people with opioid use disorder. It enables patients to take methadone at home while being monitored through video, reducing the need for daily clinic visits. Studies indicate that using Sonara carries a lower risk of breathing problems compared to some other treatments, suggesting it is a well-tolerated option for those needing methadone.

As this is a Phase 2 trial, Sonara has already passed some safety checks in earlier studies. While ongoing research will provide more information, current evidence supports its safety for use in opioid treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Sonara is unique because it leverages digital technology to enhance treatment for opioid use disorder. Unlike traditional options like methadone, buprenorphine, or naltrexone, which are medication-based, Sonara integrates a tech-enabled approach to support patient adherence and engagement. Researchers are excited about Sonara because it could improve the effectiveness of existing treatments by ensuring patients stick to their prescribed regimens. This innovative method might lead to better outcomes for individuals struggling with opioid addiction by providing real-time support and monitoring.

What evidence suggests that Sonara is effective for opioid use disorder?

Research has shown that methadone effectively treats severe opioid use disorder (OUD). However, the usual approach requires daily clinic visits, which can be inconvenient. In this trial, participants in the Sonara-enabled arm will use the Sonara app to take methadone at home while monitored through video. Early results suggest that this method could help patients maintain their treatment and reduce opioid use. Additionally, participants report greater satisfaction with Sonara's remote dosing, as it better fits their daily routines compared to clinic visits. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with severe opioid use disorder who can complete study tasks and are willing to participate in a randomized trial. It aims to help those who face challenges accessing daily methadone doses at treatment programs.

Inclusion Criteria

I can complete study questionnaires and interviews.

I am willing to be randomly assigned to a treatment group in a study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive methadone treatment with Sonara-enabled or usual take-home methods, monitored via video dosing and OC-VAS

24 weeks

Regular virtual check-ins using the Sonara application

Follow-up

Participants are monitored for retention, opioid use, and patient outcomes after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sonara

Trial Overview The trial is testing Sonara, a HIPAA-compliant web-app designed by Sonara Health, which allows patients to take methadone at home. It includes video dosing, tamper-evident seals, and tracks patient outcomes using the OC-VAS framework.

How Is the Trial Designed?

Group I: Sonara-enabled Experimental Treatment 1 Intervention

Group II: Treatment as usual Active Control 1 Intervention

Who Is Running the Clinical Trial?

Sonara Health

Lead Sponsor

Trials

2

Recruited

120+

Chestnut Health Systems

Collaborator

Trials

27

Recruited

24,500+

Published Research Related to This Trial

In a study of 533 participants over 18 months after stopping extended-release buprenorphine injection (BUP-XR), 47% reported sustained opioid abstinence, with higher rates of abstinence linked to longer treatment durations.

More than 60% of participants showed stable or improved outcomes in health-related quality of life and mental health scores, indicating that BUP-XR has a long-term positive impact on recovery from opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continued Posttrial Benefits of Buprenorphine Extended Release: RECOVER Study Findings. Boyett, B., Nadipelli, VR., Solem, CT., et al.[2023]

A 52-week randomized controlled trial involving 952 veterans is comparing the effectiveness of long-acting injectable buprenorphine (INJ-BUP) to standard sublingual buprenorphine/naloxone (SL-BUP/NLX) for treating opioid use disorder (OUD).

The study aims to determine if INJ-BUP improves retention in medication treatment and reduces opioid use, which could lead to better health outcomes and potentially save lives among veterans struggling with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale, design and methods of VA-BRAVE: a randomized comparative effectiveness trial of two formulations of buprenorphine for treatment of opioid use disorder in veterans. Petrakis, I., Springer, SA., Davis, C., et al.[2022]

In a study involving 137 participants, the adapted START NOW psychotherapy was found to be as effective as standard treatment-as-usual (TAU) for opioid use disorder, with similar attendance and drug use outcomes over 32 weeks.

START NOW psychotherapy is freely available and could be particularly beneficial in low-resource settings, making it a valuable option for treating opioid use disorder alongside medications like buprenorphine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninferiority Clinical Trial of Adapted START NOW Psychotherapy for Outpatient Opioid Treatment. Truong, A., Kablinger, A., Hartman, C., et al.[2023]

The pilot study involving 21 pregnant women with opioid dependence showed that a patient navigation (PN) intervention significantly improved abstinence from illicit opioids and reduced depression, indicating its potential effectiveness in this population.

Participants also demonstrated increased engagement with substance use treatment services and achieved adequate prenatal care, suggesting that the PN model could enhance overall health outcomes for pregnant women with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Pregnancy Treatment Interventions for Moms (OPTI-Mom): A Pilot Study. Cochran, GT., Hruschak, V., Abdullah, W., et al.[2023]

Buprenorphine is a safe and effective treatment for opioid use disorder (OUD) in emergency departments, acting as a partial mu-opioid receptor agonist with a long half-life and a ceiling effect that reduces the risk of overdose and withdrawal symptoms.

Implementing a buprenorphine program in the ED requires a comprehensive approach that includes medication-assisted treatment, counseling, and addressing the stigma associated with opioid replacement therapies to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approach to buprenorphine use for opioid withdrawal treatment in the emergency setting. Cisewski, DH., Santos, C., Koyfman, A., et al.[2019]

Medication-assisted treatment with buprenorphine via telehealth is effective in improving access to care for adults with opioid use disorder (OUD), as highlighted by a study involving 15 participants who shared their positive experiences.

Despite the benefits of telehealth, participants reported feelings of isolation, indicating the need for healthcare providers to find ways to enhance patient engagement and support to mitigate this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Opioid Use Disorder Patients Receiving Buprenorphine Through a Telehealth Program. Moore, DJ., Goyal, D., Rodriguez, L.[2021]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10774067

Remotely Observed Methadone Evaluation (ROME) Sonara is an innovative solution that reduces friction for OTPs providing life-saving methadone treatment for opioid use disorder. It works by combining a ...

2. withpower.com withpower.com/trial/sonara-for-opioid-use-disorder-99697

Sonara for Opioid Use Disorder (ROME II Trial) In a study involving 137 participants, the adapted START NOW psychotherapy was found to be as effective as standard treatment-as-usual (TAU) for opioid use ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06338280

NCT06338280 | Remotely Observed Methadone Evaluation II 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10932827/

Usability and feasibility of a take-home methadone web ... Satisfaction ratings of clinic dosing, usual take-home dosing, and the web-app dosing rated clinic dosing as interfering more with daily living than either take ...

5. jamanetwork.com jamanetwork.com/journals/jama-health-forum/fullarticle/2806516

State- and County-Level Geographic Variation in Opioid ... Studies using the National Survey on Drug Use and Health reported OUD medication treatment rates in the range of 11% to 15% for the same period.

6. techpoint.org techpoint.org/digital-innovation/boomerang-ventures-invests-1m-in-sonara-health-to-scale-hybrid-methadone-care-nationwide/

Boomerang Ventures Invests $1M in Sonara Health to Scale ... Sonara Health is transforming methadone treatment through a hybrid care platform that makes it easier for people with opioid use disorder (OUD) ...

7. researchgate.net researchgate.net/publication/382229080_A_Digital_Health_App_for_Opioid_Treatment_Programs_The_Sonara_Health_Platform_for_Video_Observed_Methadone_Take-Homes

A Digital Health App for Opioid Treatment Programs A Digital Health App for Opioid Treatment Programs: The Sonara Health Platform for Video Observed Methadone Take-Homes.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2949875923002321

Usability and feasibility of a take-home methadone web ... The baseline assessment included ratings of methadone “clinic dosing,” “unsupervised take-home dosing,” and dosing with the take-home app” to assess dosing ...