Remotely Observed Methadone Evaluation II

Phase 2

Recruiting

• Conditions: Opioid Use Disorder
• Interventions: Other: Sonara

• Registration Number: NCT06338280
• Lead Sponsor: Sonara Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-03-29
• Study Start: 2024-12-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-26
• Primary Completion: 2027-02-28
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sonara-enabled	Sonara	-

Primary Outcome Measures

Name	Time	Method
Take homes received over time	24 weeks	The number of take home doses of methadone received at 4-, 12-, and 24-weeks following randomization
Retention	24 weeks	Length of time the patient remains in treatment after study enrollment

Secondary Outcome Measures

Name	Time	Method
Urine toxicology	24 weeks	A qualitative test that detects the presence of commonly used illicit substances or their metabolites in a urine sample
Opioid cravings	24 weeks	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
Health-related quality of life	24 weeks	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
Opioid withdrawal severity	24 weeks	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)
Drug Abuse Treatment Costs Analysis	24 weeks	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)

Trial Locations

Locations (1)

FGC Wabash; 🇺🇸 Chicago, Illinois, United States