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

NCT ID: NCT06726200

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2029-01-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Injectable Buprenorphine

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

Group Type: EXPERIMENTAL

Buprenorphine Injection

Intervention Type: DRUG

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

Sublingual Buprenorphine/Naloxone

Titration onto sublingual buprenorphine/naloxone (standard of care)

Group Type: ACTIVE_COMPARATOR

Buprenorphine + naloxone (Suboxone)

Intervention Type: DRUG

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

Interventions

Buprenorphine + naloxone (Suboxone)

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

Intervention Type: DRUG

Buprenorphine Injection

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Rachel R. Luba

OTHER

Sponsor Role: lead

Responsible Party

Rachel R. Luba

Associate Research Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Substance Treatment and Research Service

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Luba, PhD

Role: CONTACT

RRL2117@CUMC.Columbia.edu

646-774-8189

John Mariani, MD

Role: CONTACT

Jmm2330@cumc.columbia.edu

212-923-3031

Facility Contacts

Administrative assistant

Role: primary

RRL2117@cumc.columbia.edu

646-774-8189

Other Identifiers

K23DA057392-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAV2503

Identifier Type: -

Identifier Source: org_study_id