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

Rachel R. Luba

Status and phase: Enrolling; Early Phase 1

Conditions: Opioid Use Disorder

Treatments: Drug: Buprenorphine Injection; Drug: Buprenorphine + naloxone (Suboxone)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06726200

AAAV2503

K23DA057392-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

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. 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Injectable Buprenorphine

Experimental group

Description:

Long-Acting Injectable Buprenorphine administered after participants receive and tolerate a single 4/1 mg sublingual buprenorphine/naloxone dose

Treatment:

Drug: Buprenorphine Injection

Sublingual Buprenorphine/Naloxone

Active Comparator group

Description:

Titration onto sublingual buprenorphine/naloxone (standard of care)

Treatment:

Drug: Buprenorphine + naloxone (Suboxone)