Opioid Use DisorderPhase 2NCT06441604

Extended-release Buprenorphine as a Novel Low-dose Induction Strategy

A Phase 2 study testing Extended-release Buprenorphine in people with Opioid Use Disorder, run by Brigham and Women's Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid Use Disorder
What is being tested?: Extended-release Buprenorphine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 27 Oct 2025to 31 Jan 2027
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

English speaking adults aged 18 and above.
diagnosis of opioid use disorder.
Self-reporting use of illicit opioids in >21 days in the prior 30 days.
Provide urine toxicology testing positive for fentanyl at baseline.

Who cannot join

Seeking medication treatment for opioid use disorder with sublingual buprenorphine or methadone.
Received buprenorphine or methadone treatment in prior 30 days.
Current diagnosis of alcohol or sedative/hypnotic use disorder.
Positive urine drug screen for benzodiazepines, alcohol and or methadone.
Physical dependence on alcohol or sedative/hypnotics.
Psychotic disorder, active suicidality or homicidally or any psychiatric condition that impair ability to provide informed consent.

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Have a history or diagnosis of Intracranial mass/bleed, seizure disorder, liver cirrhosis, renal failure, obstructive lung disease, hyperthyroidism, narrow-angle glaucoma, valvular heart disease, cardiac arrhythmias, heart failure.
Recent (within 6 months) head trauma, stroke, or myocardial infarction
Requiring treatment with opioids for acute or chronic pain.
History of hypersensitivity or allergy to buprenorphine or fentanyl.
Pregnant or breastfeeding.
Liver function test greater than 3 times upper normal limit.
Receiving medications that are strong or moderate CYP34A inducers or inhibitors (including but not limited to ketoconazole, itraconazole, clarithromycin, fluconazole, erythromycin), in the past 30 days.

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham and Women's Hospital
Boston, Massachusetts, 02118-5605

Other trials in United States

About this study

This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy. Individuals with a diagnosis of Opioid Use Disorder (OUD) (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 3 days. Participants will receive fentanyl to prevent the emergence of withdrawal. Each participant will then receive a single injection of XR-BUP after which study staff will monitor for any precipitated withdrawal.

Read the detailed description

The approach is to conduct a single ascending dose trial in a controlled human laboratory setting with individuals with a diagnosis of OUD (n=30) actively using illicit fentanyl. After obtaining informed consent and establishing eligibility, 10 participants will be scheduled for an inpatient visit lasting 3 days, 2 nights and receive XR-BUP when not yet experiencing any opioid withdrawal. Participants will receive fentanyl to prevent the emergence of withdrawal, and on the following morning, receive XR-BUP 16mg in single-blind fashion. If at least 90% successfully complete induction (success defined as experiencing no precipitated withdrawal) with the 16mg dose, then we will proceed with 10 more participants to receive the 24mg dose. If at least 90% successfully complete induction the 24mg dose, then we will proceed with 10 more participants to the 32mg dose. Timed blood samples will be collected in heparinized Vacutainer tubes via a catheter in the antecubital vein at baseline, and at 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after the XR-BUP injection.

Conditions: Opioid Use Disorder
Being tested: Extended-release Buprenorphine
Keywords: Opioid Use Disorder, Buprenorphine
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 BuprenorphineDrug
The study is a single-blind, fixed-order, dose-escalation designed trial in an inpatient setting with individuals with a DSM-5 diagnosis of OUD (n=30). The first 10 participants will receive XR-BUP 16mg in single-blind fashion. We will then proceed with 10 more participants to the 24mg dose, and finally proceed with 10 more participants to the 32mg dose. All participants will receive fentanyl to prevent withdrawal symptoms. (Figure 2). Symptomatic treatments will be provided at any sign of worsening withdrawal including evidence of precipitated withdrawal.

Study groups in NCT06441604
Study group	Role	What they receive
16mg Extended-Release Buprenorphine	Experimental	The first 10 participants will receive XR-BUP 16mg in single-blind fashion. Receives: Drug: Extended-release Buprenorphine
24mg Buprenorphine	Experimental	After first 10 participants have been completed, the next 10 participants will receive 24mg in a single-blind fashion. Receives: Drug: Extended-release Buprenorphine
32mg Buprenorphine	Experimental	After the 20 participants have been completed, the next 10 participants will receive 32mg in a single-blind fashion. Receives: Drug: Extended-release Buprenorphine

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and tolerability of XR-Buprenorphine
The primary outcome is the proportion of participants who successfully complete induction, defined as experiencing no BPOW, which will be assessed using the COWS. An increase in the COWS score by 8 or more with the total score exceeding 13, within 4 hours will be considered BPOW.
Measured: For the duration of the inpatient admission, lasting 24 hours after receipt of study drug.
Plasma-concentration curves (AUC) of buprenorphine.
The area under the plasma concentration curves (AUC) of buprenorphine will be determined.
Timed blood samples will be collected in anticoagulant Vacutainer tubes via venipuncture at baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after the XR-BUP injection. Samples will be centrifuged and frozen until analysis.
Measured: Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.

Secondary outcomes (5)

Maximum Plasma Concentration
Plasma data will be used to calculate maximum plasma concentration (Cmax) for buprenorphine, norbuprenorphine, and their glucuronides.
Measured: Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.
Minimum Plasma Concentration (Cmin),
Plasma data will be used to calculate minimum plasma concentration (Cmin) for buprenorphine, norbuprenorphine, and their glucuronides.
Measured: Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.
Time to Maximum Plasma Concentration
Plasma data will be used to calculate time to maximum plasma concentration (Tmax) for buprenorphine, norbuprenorphine, and their glucuronides.
Measured: Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.
Elimination half-life
Plasma data will be used to calculate elimination half-life (t1/2) for buprenorphine, norbuprenorphine, and their glucuronides.
Measured: Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.
Buccal Swab
DNA testing to check 3A4 activity levels.
Measured: will be done once at the baseline visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 202531 Jan 2027

First posted4 Jun 2024
Study start27 Oct 2025
Primary completion11 Jun 2026
Study completion31 Jan 2027 (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.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
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: Other
Allocation: Non-randomised
Intervention model: Sequential
Model description: The study is a single-blind, fixed-order, dose-escalation designed trial in an inpatient setting with individuals with a DSM-5 diagnosis of OUD (n=30). The first 10 participants will receive XR-BUP 16mg in single-blind fashion. We will then proceed with 10 more participants to the 24mg dose, and finally proceed with 10 more participants to the 32mg dose. All participants will receive fentanyl to prevent withdrawal symptoms. (Figure 2). Symptomatic treatments will be provided at any sign of worsening withdrawal including evidence of precipitated withdrawal.
Masking: Single blind
Who is masked: Participant
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06441604
Sponsor's protocol ID: 2024P001078
Status last verified: Jul 2026
First submitted: 8 May 2024
Last updated: 9 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Opioid Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
ClinicalTrials.gov ID: NCT06441604
Acronym / sponsor ID: 2024P001078
Conditions: Opioid Use Disorder
Keywords: Opioid Use Disorder, Buprenorphine
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 8 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: University of Utah
Study start: 27 Oct 2025 (actual)
Primary completion: 11 Jun 2026 (actual)
Study completion: 31 Jan 2027 (estimated)
First posted: 4 Jun 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.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: Single blind (participant)
Number of arms: 3
Model description: The study is a single-blind, fixed-order, dose-escalation designed trial in an inpatient setting with individuals with a DSM-5 diagnosis of OUD (n=30). The first 10 participants will receive XR-BUP 16mg in single-blind fashion. We will then proceed with 10 more participants to the 24mg dose, and finally proceed with 10 more participants to the 32mg dose. All participants will receive fentanyl to prevent withdrawal symptoms. (Figure 2). Symptomatic treatments will be provided at any sign of worsening withdrawal including evidence of precipitated withdrawal.

Arm	Type	Receives
16mg Extended-Release Buprenorphine	Experimental	Drug: Extended-release BuprenorphineThe first 10 participants will receive XR-BUP 16mg in single-blind fashion.
24mg Buprenorphine	Experimental	Drug: Extended-release BuprenorphineAfter first 10 participants have been completed, the next 10 participants will receive 24mg in a single-blind fashion.
32mg Buprenorphine	Experimental	Drug: Extended-release BuprenorphineAfter the 20 participants have been completed, the next 10 participants will receive 32mg in a single-blind fashion.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

English speaking adults aged 18 and above.
diagnosis of opioid use disorder.
Self-reporting use of illicit opioids in >21 days in the prior 30 days.
Provide urine toxicology testing positive for fentanyl at baseline.

Key exclusion criteria (13 listed)

Seeking medication treatment for opioid use disorder with sublingual buprenorphine or methadone.
Received buprenorphine or methadone treatment in prior 30 days.
Current diagnosis of alcohol or sedative/hypnotic use disorder.
Positive urine drug screen for benzodiazepines, alcohol and or methadone.
Physical dependence on alcohol or sedative/hypnotics.

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 BuprenorphineThe study is a single-blind, fixed-order, dose-escalation designed trial in an inpatient setting with individuals with a DSM-5 diagnosis of OUD (n=30). The first 10 participants will receive XR-BUP 16mg in single-blind fashion. We will then proceed with 10 more participants to the 24mg dose, and finally proceed with 10 more participants to the 32mg dose. All participants will receive fentanyl to prevent withdrawal symptoms. (Figure 2). Symptomatic treatments will be provided at any sign of worsening withdrawal including evidence of precipitated withdrawal.	Drug	16mg Extended-Release Buprenorphine, 24mg Buprenorphine, 32mg Buprenorphine

Primary outcome

Safety and tolerability of XR-Buprenorphine
Time frame: For the duration of the inpatient admission, lasting 24 hours after receipt of study drug.
The primary outcome is the proportion of participants who successfully complete induction, defined as experiencing no BPOW, which will be assessed using the COWS. An increase in the COWS score by 8 or more with the total score exceeding 13, within 4 hours will be considered BPOW.
Plasma-concentration curves (AUC) of buprenorphine.
Time frame: Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.
The area under the plasma concentration curves (AUC) of buprenorphine will be determined. Timed blood samples will be collected in anticoagulant Vacutainer tubes via venipuncture at baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after the XR-BUP injection. Samples will be centrifuged and frozen until analysis.

5 secondary outcomes

Maximum Plasma Concentration
Time frame: Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.
Minimum Plasma Concentration (Cmin),
Time frame: Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.
Time to Maximum Plasma Concentration
Time frame: Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.
Elimination half-life
Time frame: Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.
Buccal Swab
Time frame: will be done once at the baseline visit.

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 9 Jul 2026.

Related trials for Opioid Use Disorder

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Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 in people with Opioid Use Disorder, run by Brigham and Women's Hospital 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 4 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 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?

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?

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?

Safety and tolerability of XR-Buprenorphine (time frame: For the duration of the inpatient admission, lasting 24 hours after receipt of study drug.). 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?

On the ClinicalTrials.gov record for NCT06441604.

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 9 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.