Opioid Use DisorderEarly Phase 1NCT06726200
A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use
A Early Phase 1 study testing Buprenorphine + naloxone (Suboxone) and Buprenorphine Injection in people with Opioid Use Disorder, run by Rachel R. Luba at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Buprenorphine + naloxone (Suboxone) and Buprenorphine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2026to 15 Jan 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Substance Treatment and Research Service
New York, New York, 10019
Administrative assistant, 646-774-8189, RRL2117@cumc.columbia.edu
About this study
Official title: A Randomized Controlled Trial Examining Extended-Release Injectable Buprenorphine in Those Who Use High Potency Synthetic Opioids
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?
Read more
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
- Being tested
- Buprenorphine + naloxone (Suboxone), Buprenorphine Injection
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine + naloxone (Suboxone)Drug
Participants randomized to sublingual buprenorphine naloxone will initiate treatment based on clinical guidelines/standard of care
Buprenorphine InjectionDrug
Participants randomized to injectable buprenorphine naloxone will receive a 300mg injection after receiving/tolerating a single 4/1 mg sublingual buprenorphine/naloxone dose
| Study group | Role | What they receive |
|---|---|---|
| Injectable Buprenorphine | Experimental | Long-Acting Injectable Buprenorphine administered after participants receive and tolerate a single 4/1 mg sublingual buprenorphine/naloxone dose Receives: Drug: Buprenorphine Injection |
| Sublingual Buprenorphine/Naloxone | Active comparator | Titration onto sublingual buprenorphine/naloxone (standard of care) Receives: Drug: Buprenorphine + naloxone (Suboxone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 week follow up period
Secondary outcomes (3)
Time to Peak Clinical Opiate Withdrawal Scale (COWS) score
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.
Measured: During the inpatient induction period (approximately 1 overnight stay)
Peak Clinical Opiate Withdrawal Scale (COWS) score
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.
Measured: During the inpatient induction period (approximately 1 overnight stay)
Dropout during induction
Dropout during the induction period (binary)
Measured: During the inpatient induction period (approximately 1 overnight stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start25 Feb 2026
- Primary completion15 Jan 2029 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rachel R. Luba
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Rachel R. Luba, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726200
- Sponsor's protocol ID
- AAAV2503
- Other IDs
- K23DA057392-01A1
- Status last verified
- May 2026
- First submitted
- 3 Dec 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to NIDA's policy for data management and sharing, de-identified data will be deposited into the NAHDAP repository.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Examining Extended-Release Injectable Buprenorphine in Those Who Use High Potency Synthetic Opioids
- ClinicalTrials.gov ID
- NCT06726200
- Acronym / sponsor ID
- AAAV2503
- Conditions
- Opioid Use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rachel R. LubaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 15 Jan 2029 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injectable Buprenorphine | Experimental | Drug: Buprenorphine InjectionLong-Acting Injectable Buprenorphine administered after participants receive and tolerate a single 4/1 mg sublingual buprenorphine/naloxone dose |
| Sublingual Buprenorphine/Naloxone | Active comparator | Drug: Buprenorphine + naloxone (Suboxone)Titration onto sublingual buprenorphine/naloxone (standard of care) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buprenorphine + naloxone (Suboxone)Participants randomized to sublingual buprenorphine naloxone will initiate treatment based on clinical guidelines/standard of care | Drug | Sublingual Buprenorphine/Naloxone |
| Buprenorphine InjectionParticipants randomized to injectable buprenorphine naloxone will receive a 300mg injection after receiving/tolerating a single 4/1 mg sublingual buprenorphine/naloxone dose | Drug | Injectable Buprenorphine |
Primary outcome
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.
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.
3 secondary outcomes
Time to Peak Clinical Opiate Withdrawal Scale (COWS) score
Time frame: During the inpatient induction period (approximately 1 overnight stay)
Peak Clinical Opiate Withdrawal Scale (COWS) score
Time frame: During the inpatient induction period (approximately 1 overnight stay)
Dropout during induction
Time frame: During the inpatient induction period (approximately 1 overnight stay)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes. According to NIDA's policy for data management and sharing, de-identified data will be deposited into the NAHDAP repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Buprenorphine + naloxone (Suboxone) and Buprenorphine Injection in people with Opioid Use Disorder, run by Rachel R. Luba at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Luba, PhD (646-774-8189, RRL2117@CUMC.Columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Days Abstinent from Opioids (time frame: 4 week follow up period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.