Opioid Use Disorder
Conditions
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.
Interventions
OTHERSonara
Sonara virtual dosing window and engagement platform
Sponsors
Sonara Health
Chestnut Health Systems
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | 24 weeks | Length of time the patient remains in treatment after study enrollment |
| Take homes received over time | 24 weeks | The number of take home doses of methadone received at 4-, 12-, and 24-weeks following randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Urine toxicology | 24 weeks | A qualitative test that detects the presence of commonly used illicit substances or their metabolites in a urine sample |
| 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) |
| 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 |
| 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) |
Countries
United States
Outcome results
None listed