Opioid-use DisorderPhase 2NCT04352166
Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder
A Phase 2 study testing extended-release buprenorphine (BXR) and sublingual buprenorphine (BSL) in people with Opioid-use Disorder, run by Frances R Levin at 1 site in United States.
Trial summary
The study is 12-week, randomized, open-label study comparing injectable extended-release buprenorphine (Sublocade) to standard therapy (sublingual buprenorphine), to see if Sublocade will be more helpful in treating opiate use for individuals testing positive for fentanyl and related high potency drugs (HPSO). 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?
- extended-release buprenorphine (BXR) and sublingual buprenorphine (BSL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 8 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Individuals between the age of 18-65
- Voluntarily seeking treatment for opioid use
- Meets current DSM-5 criteria for Opioid Use Disorder as a primary diagnosis, with at least moderate severity
- Test positive for high potent synthetic opioids (HPSO) use
- Able to provide informed consent and comply with study procedures
Who cannot join
- Meets DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis
- Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as an active psychotic disorder or current suicide risk
- Methadone maintenance treatment within the past 30 days
- Buprenorphine maintenance treatment within the past 30 days
- Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine)
- Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients; male participants are required to use adequate forms of birth control as the exposure to sublocade on sperm and subsequent fetal development are not known
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- Unstable medical conditions, which might make participation hazardous such as uncontrolled hypertension (blood pressure >150/100), acute hepatitis, uncontrolled diabetes, or elevated liver function tests (AST and ALT >3 times the upper limit of normal
- Legally mandated to substance use disorder treatment
- Current physiological dependence on alcohol or sedative-hypnotics that would require a medically supervised detoxification-other substance use diagnoses are not exclusionary
- Individuals, who in the clinicians judgment, have a history of failed trial of buprenorphine or sublocade (e.g., history of severe opioid intoxication or overdoses despite adequate adherence to buprenorphine or sublocade), or other features of the history strongly suggest the patient is not a good candidate for outpatient treatment with buprenorphine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder Patients Using Fentanyl
The study is 12-week, randomized, open-label study comparing injectable extended-release buprenorphine (Sublocade) to standard therapy (sublingual buprenorphine), to see if Sublocade will be more helpful in treating opiate use for individuals testing positive for fentanyl and related high potency drugs (HPSO). Those receiving Sublocade will have it administered monthly and dosing will be according to the FDA prescribing instructions of 300mg for the first and second dose and 100mg for the third. Individuals receiving sublingual buprenorphine will receive standard dosing for the entire treatment trial. Participants will be asked to attend the clinic for the first 4 days during week 1 and twice weekly for the remainder of the trial.
Read the detailed description
Outpatients seeking treatment for Opioid Use Disorder (OUD) will be screened, and those eligible and consenting will be randomized (n=40) to either buprenorphine extended-release (BXR, Sublocade) or sublingual buprenorphine (BSL). Randomization will occur in a 1:1 ratio immediately prior to starting the induction process. The primary hypothesis is that BXR treatment will significantly reduce opioid use as compared to BSL. This is a 12 week outpatient trial during which participants will be asked to come into the clinic for the first 4 days of week 1 and then twice weekly there after.
For buprenorphine to be safely administered, participants must be in withdrawal from opioids. Individuals will be instructed to abstain from opioids starting at consent and will usually begin buprenorphine medication within 24 hours of consent. Because HPSO use may lead to a delayed onset of opioid withdrawal syndrome, the first day that buprenorphine is administered may not be up to three days after a participants last opioid use. Whichever day the first dose of BSL is administered will be considered the first day of the induction.
BXR Injection group. There are two dosing schemes for the BXR induction as outlined below:
- If on any day of the buprenorphine induction a participant demonstrates a high tolerance to buprenorphine by tolerating 24 mg buprenorphine SL in one day, BXR 300 mg may be administered on that study day. This includes participants who on the first day of SL buprenorphine administration tolerate 24 mg. b) If a patient is able to tolerate 16 mg of buprenorphine SL for 2 consecutive days of the induction, BXR 300 mg will be given on the second consecutive day of receiving buprenorphine SL 16 mg. The second injection of BXR 300 mg will be administered approximately 28 days later. The third BXR injection will occur approximately 28 days subsequent to the second injection at a dose of 100 mg.
Maintenance BSL treatment group: Once a participant is able to be stabilized on 16 mg to 24 mg per day during induction they will continue to receive buprenorphine in doses up to 24 mg administered once daily. Dose adjustments for craving/withdrawal/adverse effects will be made by the research psychiatrist. Medication will be dispensed on a weekly basis.
For both study arms participants will be given comfort medications to help manage their withdrawal for the first two weeks of the treatment study as needed. Comfort medications prescribed will be clonidine, clonazepam, prochlorperazine, and zolpidem.
If a participant is not in adequate withdrawal to be able to start sublingual buprenorphine (i.e., they continue to use once enrolled), they will have up to 10 days to initiate the induction for either arm of the study. If a participant is unable to start sublingual buprenorphine within 10 days of signing consent they will be considered an induction fail and will be provided referrals for other treatment options noted in the discontinuation section of the protocol.
At each visit, patients will be seen by the Research Nurse and Research Assistant for assessment of vital signs, side effects and adverse events, collection of urine for toxicology, and research assessments. The research psychiatrist will conduct weekly assessments of the psychiatric and medical status of the study participants. All participants will have a manual-guided supportive behavioral treatment session with the research psychiatrist each week. This psychosocial intervention facilitates compliance with study medication and other study procedures, promotes abstinence from opioids and other substances.
Post-study Assessments and Clinical Follow up: At week 12 (or earlier if the patient is discontinued from the study for clinical reasons or drops out) participants will be provided with clinical referrals for continuation of treatment. Post-study participants will be seen weekly for up to 4 weeks while continuing treatment with buprenorphine. Referrals will be arranged during this period for patients to continue buprenorphine or other appropriate treatment at community-based treatment programs.
This study was subject to an NIH and OHRP-mandated human subjects research suspension that included a pause of human subjects research as of June 23, 2023.
Study received a best interest continuation for participants enrolled and the last participant completed on 08/08/2023 IO removed pause on 02/18/2026 Received IRB approval to lift suspension 03/10/2026 NYSPI institutional approval to proceed with research and data analysis was granted on 03/19/2026
- Conditions
- Opioid-use Disorder
- Being tested
- extended-release buprenorphine (BXR), sublingual buprenorphine (BSL)
- Keywords
- opioid use disorder, fentanyl, treatment, Sublocade
- 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.
extended-release buprenorphine (BXR)Drug
Also called Sublocade
Three monthly injections will be provided during the course of the 12 week trial.
sublingual buprenorphine (BSL)Drug
Also called buprenorphine
On a weekly basis patients will be provided with sublingual buprenorphine to take up to 24 mg daily.
| Study group | Role | What they receive |
|---|---|---|
| extended-release buprenorphine (BXR) | Experimental | Three extended-release buprenorphine (BXR) injections to be administered roughly 28 days apart. The first and second injection will be 300 mg and the third will be 100 mg. Receives: Drug: extended-release buprenorphine (BXR) |
| sublingual buprenorphine (BSL) | Active comparator | sublingual buprenorphine (BSL) up to 24 mg will be administered once daily for 12 weeks or length of study participation. Receives: Drug: sublingual buprenorphine (BSL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Days of Opioid Use Per Week Over Time
Change was calculated as the number of days of opioid use per week over time.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start15 Dec 2020
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm, randomized (1:1 allotment), open-label trial
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frances R Levin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Frances R Levin, New York State Psychiatric Institute
- Investigators
- frances r levin, md, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352166
- Sponsor's protocol ID
- 7963
- Other IDs
- R21DA049037
- Status last verified
- Aug 2026
- First submitted
- 16 Apr 2020
- Last updated
- 27 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder Patients Using Fentanyl
- ClinicalTrials.gov ID
- NCT04352166
- Acronym / sponsor ID
- 7963
- Conditions
- Opioid-use Disorder
- Keywords
- opioid use disorder, fentanyl, treatment, Sublocade
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Frances R LevinUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Posted 27 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is 12-week, randomized, open-label study comparing injectable extended-release buprenorphine (Sublocade) to standard therapy (sublingual buprenorphine), to see if Sublocade will be more helpful in treating opiate use for individuals testing positive for fentanyl and related high potency drugs (HPSO). Those receiving Sublocade will have it administered monthly and dosing will be according to the FDA prescribing instructions of 300mg for the first and second dose and 100mg for the third. Individuals receiving sublingual buprenorphine will receive standard dosing for the entire treatment trial. Participants will be asked to attend the clinic for the first 4 days during week 1 and twice weekly for the remainder of the trial.
Detailed description
Outpatients seeking treatment for Opioid Use Disorder (OUD) will be screened, and those eligible and consenting will be randomized (n=40) to either buprenorphine extended-release (BXR, Sublocade) or sublingual buprenorphine (BSL). Randomization will occur in a 1:1 ratio immediately prior to starting the induction process. The primary hypothesis is that BXR treatment will significantly reduce opioid use as compared to BSL. This is a 12 week outpatient trial during which participants will be asked to come into the clinic for the first 4 days of week 1 and then twice weekly there after.
For buprenorphine to be safely administered, participants must be in withdrawal from opioids. Individuals will be instructed to abstain from opioids starting at consent and will usually begin buprenorphine medication within 24 hours of consent. Because HPSO use may lead to a delayed onset of opioid withdrawal syndrome, the first day that buprenorphine is administered may not be up to three days after a participants last opioid use. Whichever day the first dose of BSL is administered will be considered the first day of the induction.
BXR Injection group. There are two dosing schemes for the BXR induction as outlined below:
- If on any day of the buprenorphine induction a participant demonstrates a high tolerance to buprenorphine by tolerating 24 mg buprenorphine SL in one day, BXR 300 mg may be administered on that study day. This includes participants who on the first day of SL buprenorphine administration tolerate 24 mg. b) If a patient is able to tolerate 16 mg of buprenorphine SL for 2 consecutive days of the induction, BXR 300 mg will be given on the second consecutive day of receiving buprenorphine SL 16 mg. The second injection of BXR 300 mg will be administered approximately 28 days later. The third BXR injection will occur approximately 28 days subsequent to the second injection at a dose of 100 mg.
Maintenance BSL treatment group: Once a participant is able to be stabilized on 16 mg to 24 mg per day during induction they will continue to receive buprenorphine in doses up to 24 mg administered once daily. Dose adjustments for craving/withdrawal/adverse effects will be made by the research psychiatrist. Medication will be dispensed on a weekly basis.
For both study arms participants will be given comfort medications to help manage their withdrawal for the first two weeks of the treatment study as needed. Comfort medications prescribed will be clonidine, clonazepam, prochlorperazine, and zolpidem.
If a participant is not in adequate withdrawal to be able to start sublingual buprenorphine (i.e., they continue to use once enrolled), they will have up to 10 days to initiate the induction for either arm of the study. If a participant is unable to start sublingual buprenorphine within 10 days of signing consent they will be considered an induction fail and will be provided referrals for other treatment options noted in the discontinuation section of the protocol.
At each visit, patients will be seen by the Research Nurse and Research Assistant for assessment of vital signs, side effects and adverse events, collection of urine for toxicology, and research assessments. The research psychiatrist will conduct weekly assessments of the psychiatric and medical status of the study participants. All participants will have a manual-guided supportive behavioral treatment session with the research psychiatrist each week. This psychosocial intervention facilitates compliance with study medication and other study procedures, promotes abstinence from opioids and other substances.
Post-study Assessments and Clinical Follow up: At week 12 (or earlier if the patient is discontinued from the study for clinical reasons or drops out) participants will be provided with clinical referrals for continuation of treatment. Post-study participants will be seen weekly for up to 4 weeks while continuing treatment with buprenorphine. Referrals will be arranged during this period for patients to continue buprenorphine or other appropriate treatment at community-based treatment programs.
This study was subject to an NIH and OHRP-mandated human subjects research suspension that included a pause of human subjects research as of June 23, 2023.
Study received a best interest continuation for participants enrolled and the last participant completed on 08/08/2023 IO removed pause on 02/18/2026 Received IRB approval to lift suspension 03/10/2026 NYSPI institutional approval to proceed with research and data analysis was granted on 03/19/2026
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arm, randomized (1:1 allotment), open-label trial
| Arm | Type | Receives |
|---|---|---|
| extended-release buprenorphine (BXR) | Experimental | Drug: extended-release buprenorphine (BXR)Three extended-release buprenorphine (BXR) injections to be administered roughly 28 days apart. The first and second injection will be 300 mg and the third will be 100 mg. |
| sublingual buprenorphine (BSL) | Active comparator | Drug: sublingual buprenorphine (BSL)sublingual buprenorphine (BSL) up to 24 mg will be administered once daily for 12 weeks or length of study participation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals between the age of 18-65
- Voluntarily seeking treatment for opioid use
- Meets current DSM-5 criteria for Opioid Use Disorder as a primary diagnosis, with at least moderate severity
- Test positive for high potent synthetic opioids (HPSO) use
- Able to provide informed consent and comply with study procedures
Key exclusion criteria (10 listed)
- Meets DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis
- Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as an active psychotic disorder or current suicide risk
- Methadone maintenance treatment within the past 30 days
- Buprenorphine maintenance treatment within the past 30 days
- Known history of allergy, intolerance, or hypersensitivity to candidate medication (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 |
|---|---|---|
| extended-release buprenorphine (BXR)Also: SublocadeThree monthly injections will be provided during the course of the 12 week trial. | Drug | extended-release buprenorphine (BXR) |
| sublingual buprenorphine (BSL)Also: buprenorphineOn a weekly basis patients will be provided with sublingual buprenorphine to take up to 24 mg daily. | Drug | sublingual buprenorphine (BSL) |
Primary outcome
Change in Days of Opioid Use Per Week Over Time
Time frame: up to 12 weeks
Change was calculated as the number of days of opioid use per week over time.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)
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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. This study is not recruiting at the moment.
frances r levin, md principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing extended-release buprenorphine (BXR) and sublingual buprenorphine (BSL) in people with Opioid-use Disorder, run by Frances R Levin 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 10 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: finished, as of the sponsor's last update on 27 Aug 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Days of Opioid Use Per Week Over Time (time frame: up to 12 weeks). 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 27 Aug 2026.