Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06200740
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2023-12-08
Brief Title:
Remotely Observed Methadone Evaluation
Sponsor:
Sonara Health
Organization:
Sonara Health
Study Overview
Official Title:
Remotely Observed Methadone Evaluation ROME
Status:
COMPLETED
Status Verified Date:
2023-12
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
Brief Summary:
Opioid addiction which affects 16 million individuals worldwide can be treated using methadone a proven and effective opioid medication for treating OUD that extends retention in care reduces mortality and inhibits illicit drug use However methadone treatment is limited to federally certified Opioid Treatment Programs OTPs which must meet complex regulatory requirements and require new patients to take their dose in person six days per week presenting significant barriers to treatment To address these barriers Sonara Heath has developed the Sonara software platform which will enable OTPs to offer accelerated take-home methadone regimens while maintaining safety and diversion prevention
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R43DA056259 | NIH | None | httpsreporternihgovquickSearchR43DA056259 |