Actively Recruiting
Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
Led by Brigham and Women's Hospital · Updated on 2026-03-25
30
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
U
University of Utah
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy. Individuals with a diagnosis of Opioid Use Disorder (OUD) (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 3 days. Participants will receive fentanyl to prevent the emergence of withdrawal. Each participant will then receive a single injection of XR-BUP after which study staff will monitor for any precipitated withdrawal.
CONDITIONS
Official Title
Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English speaking adults aged 18 and above
- Diagnosis of opioid use disorder
- Self-reported use of illicit opioids on more than 21 days in the prior 30 days
- Urine toxicology test positive for fentanyl at baseline
You will not qualify if you...
- Currently seeking medication treatment for opioid use disorder with sublingual buprenorphine or methadone
- Received buprenorphine or methadone treatment in the prior 30 days
- Current diagnosis of alcohol or sedative/hypnotic use disorder
- Positive urine drug screen for benzodiazepines, alcohol, or methadone
- Physical dependence on alcohol or sedative/hypnotics
- Psychotic disorder, active suicidality or homicidality, or other psychiatric condition impairing ability to consent
- History or diagnosis of intracranial mass/bleed, seizure disorder, liver cirrhosis, renal failure, obstructive lung disease, hyperthyroidism, narrow-angle glaucoma, valvular heart disease, cardiac arrhythmias, or heart failure
- Recent (within 6 months) head trauma, stroke, or myocardial infarction
- Requiring opioids for acute or chronic pain
- History of allergy or hypersensitivity to buprenorphine or fentanyl
- Pregnant or breastfeeding
- Liver function test greater than 3 times the upper normal limit
- Use of strong or moderate CYP3A4 inducers or inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, fluconazole, erythromycin) in the past 30 days
AI-Screening
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Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02118-5605
Actively Recruiting
Research Team
J
Joji Suzuki
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
3
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