Rapid Outpatient Low-dose Initiation of Buprenorphine for OUD With Fentanyl Use

Opioid Use Disorder Clinical Trial

— ROLDI  

Official title:

Rapid Outpatient Low-dose Initiation of Buprenorphine for Individuals With OUD Using Fentanyl

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379984
• Other study ID #: 855013
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: University of Pennsylvania
• Contact: Kyle Kampman, MD
• Phone: 215 746 2764
• Email: kampman[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 0.5 mg, 0.5 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ages 18 or older

• Male, female, transgender, or non-binary

• DSM-5 criteria for opioid use disorder, moderate to severe

• Fentanyl positive on urine drug test

• Able to provide written informed consent in English prior to any study-related procedure

Exclusion Criteria:

• Pregnancy or actively lactating

• Previously documented hypersensitivity or allergy to buprenorphine or naloxone

• DSM-5 criteria for substance use disorder other than opioid use disorder (e.g., cannabis, cocaine, alcohol)

• Current benzodiazepine use

• Urine drug testing at screening positive for buprenorphine and/or methadone

• AST and/or ALT >3x upper limit of normal or total bilirubin >1.5x upper limit of normal

• eGFR <30 mL/min

• Use of CYP3A4-metabolized agents such as azole antifungals, macrolides, and protease inhibitors

• Significant medical symptoms (e.g. severe respiratory insufficiency), psychiatric symptoms, or dementia that, in the opinion of the investigators, would preclude compliance with the protocol, cooperation in the study, obtaining informed consent, or ability to safely participate in the study

• Pending legal action that could prohibit participation and/or compliance in study procedures

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine
Sublingual buprenorphine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful initiation of buprenorphine maintenance	The proportion of subjects who successfully complete buprenorphine initiation. Successful initiation is defined as: reaching total-daily dose buprenorphine 8mg or more without an increase in COWS of 6 or more from baseline (immediately prior to initiation), and without early termination of the initiation process for any reason.	12 hours