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

Trial Summary

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 data supports the effectiveness of the treatment Sonara for opioid use disorder?

The START NOW psychotherapy, which is a skills-based group therapy, has been adapted for opioid use disorder and shown to be effective in reducing risks and improving outcomes in a similar setting. This suggests that Sonara, if it includes similar components, might also be effective. ^{1 2 3 4 5}

Is Sonara safe for treating opioid use disorder?

The safety of buprenorphine, which may be similar to Sonara, has been studied in various forms like implants and injections. It is generally considered safe with a lower risk of respiratory depression (breathing problems) compared to other treatments like methadone, but it requires careful administration to avoid misuse and ensure adherence. ^{6 7 8 9 10}

How is the drug Sonara different from other opioid use disorder treatments?

Sonara appears to be related to buprenorphine, which is a partial agonist at the μ-opioid receptor, offering a lower risk of misuse and respiratory depression compared to other treatments like methadone. Novel delivery systems for buprenorphine, such as implants and extended-release injections, provide consistent medication exposure and reduce the risk of nonadherence and diversion, making them unique compared to traditional self-administered forms. ^{7 10 11 12 13}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Noninferiority Clinical Trial of Adapted START NOW Psychotherapy for Outpatient Opioid Treatment. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an opioid and addiction treatment tele-education program for healthcare providers in a rural and frontier state. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Are patients' goals in treatment associated with expected treatment outcomes? Findings from a mixed-methods study on outpatient pharmacological treatment for opioid use disorder. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Optimizing Pregnancy Treatment Interventions for Moms (OPTI-Mom): A Pilot Study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators to the Use of Medications for Opioid Use Disorder: a Rapid Review. [2021]

6. England 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. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Patient-centered Outcomes in Participants of a Buprenorphine Monthly Depot (BUP-XR) Double-blind, Placebo-controlled, Multicenter, Phase 3 Study. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of monthly buprenorphine extended-release injections on patient-centered outcomes: A long-term study. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Continued Posttrial Benefits of Buprenorphine Extended Release: RECOVER Study Findings. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Buprenorphine implants in medical treatment of opioid addiction. [2017]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Advances in the delivery of buprenorphine for opioid dependence. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Approach to buprenorphine use for opioid withdrawal treatment in the emergency setting. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Experiences of Opioid Use Disorder Patients Receiving Buprenorphine Through a Telehealth Program. [2021]