Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Standard Versus High Dose ED-Initiated Buprenorphine Induction
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Standard Versus High Dose ED-Initiated Buprenorphine Induction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
ED-ENVISION
Brief Summary:
This study is a multisite double-blind double-dummy randomized clinical trial enrolling ED patients with untreated moderate to severe opioid use disorder OUD to compare Standard Dose Induction SDI and High Dose Induction HDI on rates of participation in OUD treatment within 10 days post randomization and opioid withdrawal symptoms opioid craving and use of illicit and non-prescribed drugs
Detailed Description:
This study will recruit train and provide resources to approximately 4 ED systems throughout the US to recruit ED patients presenting with OUD not receiving medications for opioid use disorder MOUD as part of an RCT to compare SDI Zubsolv 5714 mg buprenorphinenaloxone plus 2 placebo tablets with HDI three Zubsolv 5714 mg buprenorphinenaloxone tablets to evaluate rate of participation in OUD treatment within 10 days post-randomization and differences in outcomes of tolerability opioid withdrawal symptoms craving and use of illicit drugs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| UG1DA015831 | NIH | None | None |