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Comparing Buprenorphine Formulations for Opioid Use Disorder

This study is comparing two forms of buprenorphine for treating opioid use disorder (OUD), especially for people who use fentanyl or other strong synthetic opioids. Researchers want to see if there are differences in how often people use drugs and if they have a relapse when using either buprenorphine + naloxone (Suboxone), which is taken under the tongue, or a buprenorphine injection. You might be able to join if you are 18-65 years old, are seeking OUD treatment, consistently use fentanyl or similar opioids, and meet specific diagnostic criteria. The study aims to enroll 60 participants. The current recruitment status is unclear.

Study design
This is an interventional study comparing two different buprenorphine treatments. It plans to enroll 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 4 weeks to measure days abstinent from opioids and sustained relapse.

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NCT06726200

A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use

Recruiting
EARLY_PHASE1Ages 18–65InterventionalTreatment
Rachel R. Luba
~60 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Buprenorphine + naloxone (Suboxone)Buprenorphine Injection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Days Abstinent from Opioids
Measured over 4 week follow up period
+1 more outcome measured

Conditions

Opioid Use Disorder

Explore related trials

Opioid Use Disorder

Where it's being run

1 sites across 1 states
New York1

Who to contact

Rachel Luba, PhD
[email protected]
646-774-8189
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percentage of Days Abstinent from Opioids4 week follow up period

    Abstinence from Opioids (% days abstinent; continuous; longitudinal) during each week of the 4 week follow up period measured via the timeline follow back.

  • Sustained Relapse4 week follow up period

    Sustained relapse during the 4 week follow up period (binary), defined as 5 consecutive days of illicit opioid use reported on the timeline follow back at any point during the 4 week follow up period.