RECRUITING

Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl

Quick Facts

Study Start:2024-01-09
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06089707

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older
  2. * Speak fluent English
  3. * Medically cleared to take study medication
  4. * Willing to comply with the study protocol
  5. * Provides urine sample that tests positive for fentanyl
  6. * Current moderate to severe opioid use disorder
  1. * Significant cognitive impairment resulting in inability to provide informed consent (e.g., severe dementia or intellectual disability)
  2. * Unable to read or understand study questions with assistance from the research staff
  3. * Medical symptoms interfering with their ability to answer study questions
  4. * Psychiatric symptoms interfering with their ability to answer survey questions
  5. * Currently enrolled and taking medications for OUD
  6. * Pregnant or Breastfeeding
  7. * Taking medication contraindicated with study medication
  8. * Deemed by the principal investigator or medical team to not be a good fit for the study protocol.
  9. * 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).

Contacts and Locations

Study Contact

Cecilia Bergeria, PhD
CONTACT
410-550-1979
cberge21@jhmi.edu
Anjalee Sharma, PhD
CONTACT
asharm58@jh.edu

Principal Investigator

Cecilia Bergeria, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine

Study Locations (Sites)

Johns Hopkins School of Medicine
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Cecilia Bergeria, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-09
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2024-01-09
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • buprenorphine
  • fentanyl
  • initiation to treatment

Additional Relevant MeSH Terms

  • Opioid Use Disorder