Actively Recruiting
Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl
Led by Johns Hopkins University · Updated on 2025-01-17
25
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
C
Cure Addiction Now
Collaborating Sponsor
AI-Summary
What this Trial Is About
The opioid overdose epidemic has persisted for several decades and is now further complicated by the permeation of fentanyl into the illicit opioid supply. While the effectiveness of medications to treat opioid use disorder (MOUD) have been well documented in the literature, the addition of fentanyl to the drug supply has complicated the initiation of MOUD, especially buprenorphine. Naloxone, an opioid antagonist, is currently utilized to reverse opioid overdose by displacing less-competitive ligands which bind at the mu-opioid receptor. Because induction to buprenorphine in the age of fentanyl is uncomfortable and can take several days to stabilize a patient on a therapeutic dose, the use of naloxone prior to buprenorphine can aid in a safe and rapid transition to buprenorphine treatment, without the effect of unintended prolonged precipitated withdrawal which can occur following the displacement of fentanyl by buprenorphine on the mu-opioid receptor. Therefore, this project will assess feasibility and acceptability of naloxone-facilitated buprenorphine initiation using a single-ascending dose design. The investigators will examine whether a single dose of buprenorphine is tolerated following administration of naloxone among a small group of individuals. If the dose is tolerated, the investigators will administer a larger dose among another small group of individuals. The investigators will examine the tolerability of up to 4 doses of buprenorphine following naloxone. This buprenorphine induction method has been characterized in case studies but it has not been evaluated in an empirical, systematic way in a controlled setting. This study will take place within an residential facility at Johns Hopkins Bayview Medical Campus, and will have immediate, real-world applicability in establishing a rapid, safe, and effective option to transition people with chronic fentanyl use to buprenorphine treatment.
CONDITIONS
Official Title
Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Speak fluent English
- Medically cleared to take study medication
- Willing to comply with the study protocol
- Provides urine sample that tests positive for fentanyl
- Current moderate to severe opioid use disorder
You will not qualify if you...
- Significant cognitive impairment preventing informed consent
- Unable to understand study questions even with staff help
- Medical symptoms that interfere with answering questions
- Psychiatric symptoms that interfere with answering questions
- Currently taking medications for opioid use disorder
- Pregnant or breastfeeding
- Taking medication that conflicts with study medication
- Deemed unsuitable for the study by the investigator or medical team
- Current or past hypo/hypertension outside 90/60 to 140/90 range or adverse heart event in past 3 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
C
Cecilia Bergeria, PhD
CONTACT
A
Anjalee Sharma, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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