Actively Recruiting
A Randomized Controlled Trial Examining Extended-Release Injectable Buprenorphine in Those Who Use High Potency Synthetic Opioids
Led by Rachel R. Luba · Updated on 2026-06-02
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rachel R. Luba
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two forms of buprenorphine—sublingual tablets versus a long-acting injectable—to treat opioid use disorder in adults who use fentanyl or other strong synthetic opioids. The study aims to compare how often participants use drugs and experience relapse after starting either treatment. It also explores how factors like body fat, weight, fentanyl use before treatment, blood levels of buprenorphine, cravings, and withdrawal symptoms affect treatment outcomes. Participants will begin treatment during a brief overnight hospital stay, where they receive either a single dose of sublingual buprenorphine/naloxone followed by the injectable or standard sublingual buprenorphine/naloxone titration. Blood and urine samples will be collected during the hospital stay and follow-up visits. These visits occur at 1, 2, 3, and 4 weeks after leaving the hospital to monitor drug use, cravings, withdrawal, quality of life, and physical health. Throughout the study, participants will provide samples and attend in-person follow-ups to assess their progress and treatment effects. Researchers will measure the percentage of days participants remain abstinent from opioids and rates of sustained relapse during the 4-week follow-up. They will also evaluate withdrawal severity and dropout rates during the initial inpatient period. The total participation time includes the inpatient stay plus 4 weeks of follow-up visits.
CONDITIONS
Brief Title
A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65
- Voluntarily seeking treatment for opioid use disorder
- Consistent use of fentanyl or other high potency synthetic opioids
- Meets DSM-5 criteria for opioid use disorder with at least moderate severity
- Able to provide written informed consent in English and willing to comply with study procedures
You will not qualify if you...
- Meets DSM-5 criteria for another substance use disorder as the primary diagnosis
- Has an active, unmanaged psychiatric condition that would make participation hazardous (e.g., acute psychosis, current suicidality, current manic episode)
- Has an active, unmanaged medical condition that would make participation hazardous or preclude use of buprenorphine or ancillary medications for withdrawal (e.g., unmanaged hypertension, unmanaged diabetes, clinically significant abnormality on ECG, acute hepatitis)
- Buprenorphine or methadone treatment in the past 30 days
- Known allergy, hypersensitivity or intolerance to buprenorphine
- Pregnancy, lactation, or unwillingness to use adequate contraceptive methods
- Current physiological dependence on sedative-hypnotics or alcohol that would require medically supervised detoxification
- Liver function tests greater than 2 times the upper limit of normal
- Use of medications or herbal products with known CYP3A4 inhibition or induction properties in the past 30 days
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 overnight stay for inpatient induction followed by 4 weeks of treatment
Participants receive either long-acting injectable buprenorphine after tolerating a single sublingual dose, or titration onto sublingual buprenorphine/naloxone following clinical guidelines.
1 inpatient induction visit (approximately 1 overnight stay) and weekly visits for up to 4 weeks
Duration - 4 weeks
Participants are monitored for opioid abstinence and relapse during the 4-week follow-up period after treatment.
Weekly visits for 4 weeks
Trial Site Locations
Total: 1 location
1
Substance Treatment and Research Service
New York, New York, United States, 10019
Actively Recruiting
Research Team
R
Rachel Luba, PhD
J
John Mariani, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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