Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338280
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-22
Brief Title:
Remotely Observed Methadone Evaluation II
Sponsor:
Sonara Health
Organization:
Sonara Health
Study Overview
Official Title:
Remote Observed Methadone Evaluation Phase II ROME II Retention and Costs of Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROME II
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None