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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
100
Sonara virtual dosing window and engagement platform
FGC Wabash
Chicago, Illinois, United States
RECRUITINGRetention
Length of time the patient remains in treatment after study enrollment
Time frame: 24 weeks
Take homes received over time
The number of take home doses of methadone received at 4-, 12-, and 24-weeks following randomization
Time frame: 24 weeks
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
Time frame: 24 weeks
Urine toxicology
A qualitative test that detects the presence of commonly used illicit substances or their metabolites in a urine sample
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 24 weeks
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