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

NCT06726200 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: AAAV2503K23DA057392-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

• Percentage of Days Abstinent from Opioids

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

  4 week follow up period

• Sustained Relapse

  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.

  4 week follow up period

Secondary Outcomes (3)

• Time to Peak Clinical Opiate Withdrawal Scale (COWS) score

  During the inpatient induction period (approximately 1 overnight stay)

• Peak Clinical Opiate Withdrawal Scale (COWS) score

  During the inpatient induction period (approximately 1 overnight stay)

• Dropout during induction

  During the inpatient induction period (approximately 1 overnight stay)

Other Outcomes (3)

• Exploratory Outcome 1: Craving

  Induction Period (Overnight Inpatient Stay) and 4-week follow up period

• Exploratory Outcome 2: Clinical Opiate Withdrawal Scale (COWS) Score

  Induction Period (Overnight Inpatient Stay) and 4-week follow up period

• Exploratory Outcome 3: Time to first use of illicit opioids

  4-week follow up period

Study Arms (2)

Injectable Buprenorphine

EXPERIMENTAL

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

Drug: Buprenorphine Injection

Sublingual Buprenorphine/Naloxone

ACTIVE COMPARATOR

Titration onto sublingual buprenorphine/naloxone (standard of care)

Drug: Buprenorphine + naloxone (Suboxone)

Interventions

Buprenorphine + naloxone (Suboxone) DRUG

Participants randomized to sublingual buprenorphine naloxone will initiate treatment based on clinical guidelines/standard of care

Sublingual Buprenorphine/Naloxone

Buprenorphine Injection DRUG

Participants randomized to injectable buprenorphine naloxone will receive a 300mg injection after receiving/tolerating a single 4/1 mg sublingual buprenorphine/naloxone dose

Injectable Buprenorphine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rachel R. Luba: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Substance Treatment and Research Service

New York, New York, 10019, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine; Naloxone; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Central Study Contacts

Rachel Luba, PhD

CONTACT

646-774-8189; RRL2117@CUMC.Columbia.edu

John Mariani, MD

CONTACT

212-923-3031; jm2330@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Research Scientist

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 10, 2024
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 15, 2029
• Study Completion (Estimated): January 15, 2029
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified data will be made available no later than when the primary outcome paper is published or when the award ends. The data will be stored in the repository for at least 10 years after the funding period ends.
• Access Criteria: Once released to the repository, the investigator will not control data access.

Locations

US (1)