Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-08
Brief Title:
Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine XR-BUP as a novel low-dose buprenorphine induction strategy Individuals with a DSM-5 diagnosis of OUD n30 will be admitted to an inpatient unit to complete study procedures over the course of 5 days Participants will receive fentanyl to prevent the emergence of withdrawal Each participant will then receive a single injection of XR-BUP after which study staff will monitor for any precipitated withdrawal
Detailed Description:
The approach is to conduct a single ascending dose trial in a controlled human laboratory setting with individuals with a DSM-5 diagnosis of OUD n30 actively using illicit fentanyl After obtaining informed consent and establishing eligibility 10 participants will be scheduled for an inpatient visit lasting 5 days-4 nights and receive XR-BUP when not yet experiencing any opioid withdrawal Participants will receive fentanyl to prevent the emergence of withdrawal and on the following morning receive XR-BUP 16mg in single-blind fashion If at least 90 successfully complete induction success defined as experiencing no precipitated withdrawal with the 16mg dose then we will proceed with 10 more participants to receive the 24mg dose If at least 90 successfully complete induction the 24mg dose then we will proceed with 10 more participants to the 32mg dose Timed blood samples will be collected in heparinized Vacutainer tubes via a catheter in the antecubital vein at baseline and at 05 1 2 4 6 8 12 24 48 and 72 hours after the XR-BUP injection
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