Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379984
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-04-18
Brief Title:
Rapid Outpatient Low-dose Initiation of Buprenorphine for OUD with Fentanyl Use
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Rapid Outpatient Low-dose Initiation of Buprenorphine for Individuals with OUD Using Fentanyl
Status:
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:
ROLDI
Brief Summary:
The goal of this clinical trial is to learn if buprenorphine can be started for opioid use disorder with fentanyl use without requiring or precipitating opioid withdrawal To be eligible participants must have moderate or severe opioid use disorder and must have fentanyl detected on a urine drug test
Participants will be admitted to a monitored research unit for the trial They will be randomized to start buprenorphine with either standard initiation or with a new approach called rapid outpatient low-dose initiation ROLDI
For standard initiation participants will be instructed to arrive to the unit with at least 8 hours since last fentanyl use Once they have at least moderately severe opioid withdrawal Clinical Opiate Withdrawal Scale COWS 11 or higher participants will receive 2 mg 2 mg 4 mg and then 8 mg sublingual buprenorphine with doses every 2 hours They will then continue 8-12 mg twice daily This is the current standard of care
For ROLDI participants will not be required to have a period abstinence they will have no or minimal withdrawal COWS 4 or less when starting buprenorphine and participants will take 05 mg 05 mg 1 mg 1 mg 1 mg and then 4 mg sublingual buprenorphine with dosing every two hours They will then continue 8-12 mg twice daily
The main aim of this clinical trial is to assess whether ROLDI is safe feasible acceptable to patients and worthwhile to study in a larger trial The secondary aim is to describe fentanyl and norfentanyl pharmacokinetics that is to say fentanyl and norfentanyl concentration in blood and urine during early abstinence to understand why some people using fentanyl develop precipitated withdrawal with standard initiation
Participants will be admitted to a monitored research unit for the trial They will be randomized to start buprenorphine with either standard initiation or with a new approach called rapid outpatient low-dose initiation ROLDI
For standard initiation participants will be instructed to arrive to the unit with at least 8 hours since last fentanyl use Once they have at least moderately severe opioid withdrawal Clinical Opiate Withdrawal Scale COWS 11 or higher participants will receive 2 mg 2 mg 4 mg and then 8 mg sublingual buprenorphine with doses every 2 hours They will then continue 8-12 mg twice daily This is the current standard of care
For ROLDI participants will not be required to have a period abstinence they will have no or minimal withdrawal COWS 4 or less when starting buprenorphine and participants will take 05 mg 05 mg 1 mg 1 mg 1 mg and then 4 mg sublingual buprenorphine with dosing every two hours They will then continue 8-12 mg twice daily
The main aim of this clinical trial is to assess whether ROLDI is safe feasible acceptable to patients and worthwhile to study in a larger trial The secondary aim is to describe fentanyl and norfentanyl pharmacokinetics that is to say fentanyl and norfentanyl concentration in blood and urine during early abstinence to understand why some people using fentanyl develop precipitated withdrawal with standard initiation
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None