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

Phase

Condition

Opioid Use Disorder

Treatment

Buprenorphine + naloxone (Suboxone)

Buprenorphine Injection

Clinical Study ID

NCT06726200

AAAV2503

K23DA057392-01A1

Ages 18-65
All Genders

Study 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 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.

Eligibility Criteria

Inclusion

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 studyprocedures

Exclusion

Exclusion Criteria:

Meets DSM-5 criteria for another substance use disorder as the primary diagnosis
Has an active, unmanaged psychiatric condition that would make participationhazardous (e.g., acute, psychosis, current suicidality, current manic episode)
Has an active, unmanaged medical condition that would make participation hazardousor preclude use of buprenorphine or ancillary medications for withdrawal (e.g.,unmanaged hypertension, unmanaged diabetes, clinically significant abnormality onECG, 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 requiremedically supervised detoxification
Liver function tests > 2x the upper limit of normal
Use of medications or herbal products with known CYP3A4 inhibition or inductionproperties in the past 30 days

Study Design