Remotely Observed Methadone Evaluation II

Opioid Use Disorder Clinical Trial

— ROME II  

Official title:

Remote Observed Methadone Evaluation Phase II (ROME II): Retention and Costs of Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06338280
• Other study ID #: VDW002
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: March 2024
• Source: Sonara Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willing to participate in a randomized trial

• Able to complete study instruments and interviews

Exclusion criteria:

• 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).

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Other:
• Sonara
Sonara virtual dosing window and engagement platform

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sonara Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	Length of time the patient remains in treatment after study enrollment	24 weeks
Primary	Take homes received over time	The number of take home doses of methadone received at 4-, 12-, and 24-weeks following randomization	24 weeks
Secondary	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	24 weeks
Secondary	Urine toxicology	A qualitative test that detects the presence of commonly used illicit substances or their metabolites in a urine sample	24 weeks
Secondary	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)	24 weeks
Secondary	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	24 weeks
Secondary	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)	24 weeks