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NCT Number: NCT06726200

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

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Substance Treatment and Research Service

New York, 10019, United States

Location status: Recruiting

Location contact

Administrative assistant

CONTACT

[email protected]

646-774-8189

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buprenorphine + naloxone (Suboxone)

Drug

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

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

Primary outcomes

  1. Percentage of Days Abstinent from Opioids

    Time frame: 4 week follow up period

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

  2. Sustained Relapse

    Time frame: 4 week follow up period

    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.

Secondary outcomes

  1. Time to Peak Clinical Opiate Withdrawal Scale (COWS) score

    Time frame: 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.

  2. Peak Clinical Opiate Withdrawal Scale (COWS) score

    Time frame: 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.

  3. Dropout during induction

    Time frame: During the inpatient induction period (approximately 1 overnight stay)

    Dropout during the induction period (binary)

Other outcomes

  1. Exploratory Outcome 1: Craving

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

    Craving as reported on the Opioid Craving Visual Analog Scale OC-VAS (longitudinal; continuous) during induction and follow up. The OC-VAS ranges from 0-100mm with higher ratings indicating more intense/severe craving.

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

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

    Opioid Withdrawal Symptoms as reported on the Clinical Opiate Withdrawal Scale (COWS; longitudinal; continuous) during induction and follow up. The COWS ranges from 0-48 with higher scores indicating more severe opioid withdrawal symptoms.

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

    Time frame: 4-week follow up period

    Time to first use of illicit opioids during the 4-week follow up period (time-to-event/survival)

Study contacts

Contact information is provided by the study sponsor or research team.

John Mariani, MD

CONTACT

[email protected]

212-923-3031

Rachel Luba, PhD

CONTACT

[email protected]

646-774-8189

Sponsors and collaborators

Lead sponsor

Rachel R. Luba

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

A Randomized Controlled Trial Examining Extended-Release Injectable Buprenorphine in Those Who Use High Potency Synthetic Opioids

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 10, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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