NCT06726200 · Rachel R. Luba
A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use
What this study is about
The goal of this clinical trial is to compare buprenorphine formulations (sublingual buprenorphine versus long-acting injectable buprenorphine) for treating opioid use disorder among individuals who use fentanyl and/or other high potency synthetic opioids. Individuals aged 18-65 will be eligible for enrollment.
View original scientific description
The goal of this clinical trial is to compare buprenorphine formulations (sublingual buprenorphine versus long-acting injectable buprenorphine) for treating opioid use disorder among individuals who use fentanyl and/or other high potency synthetic opioids. Individuals aged 18-65 will be eligible for enrollment. The main questions it aims to answer are: Are there differences in frequency of drug use after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine? Are there differences in rates of sustained relapse after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine? Investigators also seek to understand and explore: How factors like body fat, body weight, and quantity of fentanyl use before treatment influence treatment outcomes. How blood levels of buprenorphine and its metabolite norbuprenorphine early on in treatment may influence treatment outcomes. How factors like craving and opioid withdrawal symptoms influence treatment outcomes. Participants will: Complete a brief overnight hospital stay in an inpatient research unit. This hospital stay will enable participants to start treatment with either sublingual buprenorphine or injectable buprenorphine. Provide blood and urine samples while on the inpatient unit and at follow up. Complete in-person follow up visits at 1-, 2-, 3- and 4-weeks after leaving the hospital to measure drug use, craving, withdrawal, quality of life, and physical health.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Aged 18 to 65
- Voluntarily seeking treatment for opioid use disorder (OUD)
- Consistent use of fentanyl or other high potency synthetic opioids
- Meets DSM-5 criteria for OUD with at least moderate severity
- Able to provide written informed consent in English and willing to comply with study procedures
Exclusion criteria
- 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 \> 2x the upper limit of normal
- Use of medications or herbal products with known CYP3A4 inhibition or induction properties in the past 30 days
Where
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations