Status:
RECRUITING
Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Cure Addiction Now
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 tr...
Detailed Description
Emergent data suggest that individuals with fentanyl use experience prolonged, uncomfortable buprenorphine inductions that can commonly result in instances of unintended precipitated withdrawal. Bupre...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Significant cognitive impairment resulting in inability to provide informed consent (e.g., severe dementia or intellectual disability)
- Unable to read or understand study questions with assistance from the research staff
- Medical symptoms interfering with their ability to answer study questions
- Psychiatric symptoms interfering with their ability to answer survey questions
- Currently enrolled and taking medications for OUD
- Pregnant or Breastfeeding
- Taking medication contraindicated with study medication
- Deemed by the principal investigator or medical team to not be a good fit for the study protocol.
- Current or history of hypo/hypertension (i.e., no less than 90/60, no greater than 140/90) or adverse cardiovascular event in the past three years (e.g. significant cardiac arrhythmia, myocardiac infarction, endocarditis).
Key Trial Info
Start Date :
January 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06089707
Start Date
January 9 2024
End Date
January 1 2026
Last Update
January 17 2025
Active Locations (1)
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1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21224