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

Early Phase 1

Not yet recruiting

• Conditions: Opioid Use Disorder
• Interventions: Drug: Buprenorphine Injection; Drug: Buprenorphine + naloxone (Suboxone)

• Registration Number: NCT06726200
• Lead Sponsor: Rachel R. Luba

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 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-,4-, 8- and 12-weeks after leaving the hospital to measure drug use, craving, withdrawal, quality of life, and physical health.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Study Start: 2025-04-15
• Primary Completion: 2029-01-15
• Study Completion: 2029-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injectable Buprenorphine	Buprenorphine Injection	Long-Acting Injectable Buprenorphine administered after participants receive and tolerate a single 4/1 mg sublingual buprenorphine/naloxone dose
Sublingual Buprenorphine/Naloxone	Buprenorphine + naloxone (Suboxone)	Titration onto sublingual buprenorphine/naloxone (standard of care)

Primary Outcome Measures

Name	Time	Method
Percentage of Days Abstinent from Opioids	12 week follow up period	Abstinence from Opioids (% days abstinent; continuous; longitudinal) during each week of the 12 week follow up period measured via the timeline follow back.
Sustained Relapse	12 week follow up period	Sustained relapse during the 12 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 12 week follow up period.

Secondary Outcome Measures

Name	Time	Method
Time to Peak Clinical Opiate Withdrawal Scale (COWS) score	During the inpatient induction period (approximately 1 overnight stay)	The time to peak Clinical Opiate Withdrawal Scale (COWS) score during the induction period (time-to-event/survival). The COWS ranges from 0-48 with higher scores indicating more severe opioid withdrawal symptoms.
Peak Clinical Opiate Withdrawal Scale (COWS) score	During the inpatient induction period (approximately 1 overnight stay)	The peak Clinical Opiate Withdrawal Scale (COWS) score during the induction period (continuous). The COWS ranges from 0-48 with higher scores indicating more severe opioid withdrawal symptoms.
Dropout during induction	During the inpatient induction period (approximately 1 overnight stay)	Dropout during the induction period (binary)

Trial Locations

Locations (1)

Substance Treatment and Research Service; 🇺🇸 New York, New York, United States