Status:

RECRUITING

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

Lead Sponsor:

Rachel R. Luba

Collaborating Sponsors:

National Institute on Drug Abuse (NIDA)

Conditions:

Opioid Use Disorder

Eligibility:

All Genders

18-65 years

Phase:

EARLY_PHASE1

Brief Summary

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 u...

Eligibility Criteria

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

Key Trial Info

Start Date :

August 1 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 15 2029

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06726200

Start Date

August 1 2026

End Date

January 15 2029

Last Update

March 4 2026

Active Locations (1)

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1

Substance Treatment and Research Service

New York, New York, United States, 10019