New method to start buprenorphine treatment for people using fentanyl
Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl
This study is testing a new way to start buprenorphine treatment for people using fentanyl to see if using naloxone can make the process easier and safer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06089707 on ClinicalTrials.gov |
What this trial studies
This project evaluates a novel approach to initiate buprenorphine treatment for individuals with opioid use disorder who have recently used fentanyl. It focuses on using naloxone to facilitate a quicker and safer transition to buprenorphine, addressing the challenges posed by prolonged and uncomfortable inductions. Participants will undergo a brief screening process followed by a residential stay at a clinical research unit to assess the feasibility and acceptability of this method. The study aims to improve treatment retention and reduce the risk of withdrawal symptoms during the induction phase.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with moderate to severe opioid use disorder who have recently tested positive for fentanyl.
Not a fit: Patients currently taking medications for opioid use disorder or those with significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the initiation of buprenorphine treatment for patients struggling with fentanyl use, leading to better treatment outcomes.
How similar studies have performed: While the use of naloxone in this context is innovative, similar studies have shown promise in improving treatment transitions for opioid use disorder.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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).
Where this trial is running
Baltimore, Maryland
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Cecilia Bergeria, PhD — Johns Hopkins School of Medicine
- Study coordinator: Cecilia Bergeria, PhD
- Email: cberge21@jhmi.edu
- Phone: 410-550-1979
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.