Recruiting
Early Phase 1

Buprenorphine vs. Buprenorphine

Sponsor:

Rachel R. Luba

Code:

NCT06726200

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Buprenorphine + naloxone (Suboxone)

Buprenorphine Injection

Study Details

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 ID

NCT06726200

Start date

Feb 25, 2026

Status verified date

May, 2026

Completion date

Jan 15, 2029

Anticipated

Primary completion date

Jan 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Injectable Buprenorphine

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

active comparator: Sublingual Buprenorphine/Naloxone

Titration onto sublingual buprenorphine/naloxone (standard of care)

Interventions

Buprenorphine + naloxone (Suboxone)

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

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

Primary outcome measure

  • Percentage of Days Abstinent from Opioids [ Time Frame: 4 week follow up period ]
  • Sustained Relapse [ Time Frame: 4 week follow up period ]

Central Contacts and Locations

Central contacts

Rachel Luba, PhD

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

John Mariani, MD

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

Locations

Substance Treatment and Research Service

Recruiting

New York, New York, United States, 10019

Contacts

Administrative assistant

646-774-8189RRL2117@cumc.columbia.edu

More Information

Sponsor

Rachel R. Luba

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rachel R. Luba on 2026-06-02.