Opioid Use DisorderPhase 1NCT06086275
Oral Buprenorphine as a Novel Low-dose Induction Strategy for Opioid Use Disorder
A Phase 1 study testing Buprenorphine in people with Opioid Use Disorder, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This is a human laboratory-based, randomized, cross-over study in which buprenorphine will be administered to healthy volunteers (n=22) in 3 separate inpatient 2-night visits, at least 1 week apart. At each visit, the participant will receive a single dose buprenorphine, either 0.15mg IV, 8mg PO, or 16mg PO. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Buprenorphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2024to 1 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking adults aged 18 and above.
- In good physical health as determined by routine medical screening consisting of a complete physical exam, safety labs and EKG.
- Baseline vital signs with HR between 60 and 100, SBP between 90 and 160mmHg, and respiratory rate between 12 and 20 breaths per minute.
- Prior personal history of opioid use, therapeutic or non-therapeutic in past the 12 months.
Who cannot join
- DSM-5 diagnosis of any substance use disorder excluding tobacco.
- Presence of any alcohol, cannabis, opioids (including methadone, buprenorphine) or any other illicit substances on urine toxicology at any study visit, including cocaine, amphetamines, and benzodiazepines.
- Receiving treatment with opioid analgesic in last 60 days, or anticipate requiring opioids during the proposed trial, or up to 30 days after the trial completion
- Baseline PHQ-9 or GAD7 > 10 (i.e. moderate depression/anxiety)
- History of chronic pain
- Psychotic disorder, active suicidality or homicidally, or any psychiatric condition that impair ability to provide informed consent.
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- History of hypersensitivity or allergy to buprenorphine or naltrexone
- 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, 02115
About this study
Official title: Oral Buprenorphine as a Novel Low-Dose Induction Strategy for Individuals With Opioid Use Disorder
This is a human laboratory-based, randomized, cross-over study in which buprenorphine will be administered to healthy volunteers (n=22) in 3 separate inpatient 2-night visits, at least 1 week apart. At each visit, the participant will receive a single dose buprenorphine, either 0.15mg IV, 8mg PO, or 16mg PO. The order for the first dose administered will be fixed to the IV dose, and the subsequent doses will be randomized and counterbalanced to 8mg or 16mg PO. Participants will be given naltrexone to produce opioid blockade to eliminate the risk for opioid dependence in individuals without OUD. Timed blood samples will be collected up to 24 hours.
Read the detailed description
The approach is to conduct a randomized, cross-over trial in a controlled human laboratory setting with healthy volunteers (n=22). After obtaining informed consent, eligible participants will be scheduled for 3 separate two-night test days to receive 0.15mg IV, 8mg PO, or 16mg PO of buprenorphine. The first dose administered will be fixed to an open-label IV dose, and the subsequent doses will be randomized and counterbalanced to 8mg or 16mg PO. Visits will be scheduled at least 1 week apart to allow for washout of drug. One hour prior to receipt of the buprenorphine dose, all participants will be fed a standardized light breakfast. The IV dose will be given after establishing IV access, while the PO doses will be swallowed whole. Participants will also receive oral naltrexone 100mg 24 hours prior to each dosing to provide blockade at the mu-receptor, as well as 50mg PO at the study visit itself prior to receipt of buprenorphine. 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, 8, and 24 hours. Samples will be centrifuged and frozen until analysis.
- Conditions
- Opioid Use Disorder
- Being tested
- 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.
BuprenorphineDrug
At each visit, the participant will receive a single dose of buprenorphine, either 0.15mg IV, 8mg PO, or 16mg PO. The order for the first dose administered will be fixed to the IV dose, and the subsequent doses will be randomized and counterbalanced to 8mg or 16mg PO.
| Study group | Role | What they receive |
|---|---|---|
| 8mg PO buprenorphine | Experimental | After the open-label period, the participant will receive 8mg PO, then 16mg PO will be administered in the following visit. Receives: Drug: Buprenorphine |
| 16mg PO buprenorphine | Experimental | After the open-label period, the participant will receive 16mg PO, then 8mg PO will be administered in the following visit. Receives: Drug: Buprenorphine |
| 0.15mg IV Dose | Experimental | The first dose administered will be fixed to an open-label 0.15mg IV dose. Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 heparinized Vacutainer tubes via a catheter in the antecubital vein at baseline, and at 0.5, 1, 2, 4, 8, and 24 hours. Samples will be centrifuged and frozen until analysis.
Measured: Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.
Secondary outcomes (8)
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, 8, 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, 8, and 24 hours after study drug administration.
Volume of Distribution
Plasma data will be used to calculate volume of distribution (Vd) for buprenorphine, norbuprenorphine, and their glucuronides.
Measured: Baseline, 0.5, 1, 2, 4, 8, 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, 8, and 24 hours after study drug administration.
Total Clearance
Plasma data will be used to calculate total clearance (CL) for buprenorphine, norbuprenorphine, and their glucuronides.
Measured: Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.
Pupil Size
Pupil size will be measured through visual inspection both before and after buprenorphine dosing to confirm opioid blockade.
Measured: Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.
The Drug Effects Questionnaire
To confirm opioid blockade, subjective and objective opioid effects will be measured using previously validated Drug Evaluation Questionnaire (DEQ). The DEQ is a 5-item questionnaire where participants answer questions on a sliding scale from 0-100, where 0 indicates lower levels drug effects and 100 indicates higher levels of drug effects.
Measured: Baseline, 0.5, 1, 2, 4, 8, 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.
- First posted17 Oct 2023
- Study start4 Jun 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will first receive the IV arm in fixed order, in an open-label fashion. Subsequently, participants will be randomized to the two PO.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Responsible party
- Principal investigator, Joji Suzuki, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086275
- Sponsor's protocol ID
- 2023P002634
- Status last verified
- Oct 2025
- First submitted
- 3 Oct 2023
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Buprenorphine as a Novel Low-Dose Induction Strategy for Individuals With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06086275
- Acronym / sponsor ID
- 2023P002634
- Conditions
- Opioid Use Disorder
- Keywords
- opioid use disorder, buprenorphine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- University of Utah
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 17 Oct 2023 (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.
This is a human laboratory-based, randomized, cross-over study in which buprenorphine will be administered to healthy volunteers (n=22) in 3 separate inpatient 2-night visits, at least 1 week apart. At each visit, the participant will receive a single dose buprenorphine, either 0.15mg IV, 8mg PO, or 16mg PO. The order for the first dose administered will be fixed to the IV dose, and the subsequent doses will be randomized and counterbalanced to 8mg or 16mg PO. Participants will be given naltrexone to produce opioid blockade to eliminate the risk for opioid dependence in individuals without OUD. Timed blood samples will be collected up to 24 hours.
Detailed description
The approach is to conduct a randomized, cross-over trial in a controlled human laboratory setting with healthy volunteers (n=22). After obtaining informed consent, eligible participants will be scheduled for 3 separate two-night test days to receive 0.15mg IV, 8mg PO, or 16mg PO of buprenorphine. The first dose administered will be fixed to an open-label IV dose, and the subsequent doses will be randomized and counterbalanced to 8mg or 16mg PO. Visits will be scheduled at least 1 week apart to allow for washout of drug. One hour prior to receipt of the buprenorphine dose, all participants will be fed a standardized light breakfast. The IV dose will be given after establishing IV access, while the PO doses will be swallowed whole. Participants will also receive oral naltrexone 100mg 24 hours prior to each dosing to provide blockade at the mu-receptor, as well as 50mg PO at the study visit itself prior to receipt of buprenorphine. 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, 8, and 24 hours. Samples will be centrifuged and frozen until analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All participants will first receive the IV arm in fixed order, in an open-label fashion. Subsequently, participants will be randomized to the two PO.
| Arm | Type | Receives |
|---|---|---|
| 8mg PO buprenorphine | Experimental | Drug: BuprenorphineAfter the open-label period, the participant will receive 8mg PO, then 16mg PO will be administered in the following visit. |
| 16mg PO buprenorphine | Experimental | Drug: BuprenorphineAfter the open-label period, the participant will receive 16mg PO, then 8mg PO will be administered in the following visit. |
| 0.15mg IV Dose | Experimental | Drug: BuprenorphineThe first dose administered will be fixed to an open-label 0.15mg IV dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking adults aged 18 and above.
- In good physical health as determined by routine medical screening consisting of a complete physical exam, safety labs and EKG.
- Baseline vital signs with HR between 60 and 100, SBP between 90 and 160mmHg, and respiratory rate between 12 and 20 breaths per minute.
- Prior personal history of opioid use, therapeutic or non-therapeutic in past the 12 months.
Key exclusion criteria (10 listed)
- DSM-5 diagnosis of any substance use disorder excluding tobacco.
- Presence of any alcohol, cannabis, opioids (including methadone, buprenorphine) or any other illicit substances on urine toxicology at any study visit, including cocaine, amphetamines, and benzodiazepines.
- Receiving treatment with opioid analgesic in last 60 days, or anticipate requiring opioids during the proposed trial, or up to 30 days after the trial completion
- Baseline PHQ-9 or GAD7 > 10 (i.e. moderate depression/anxiety)
- History of chronic pain
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 |
|---|---|---|
| BuprenorphineAt each visit, the participant will receive a single dose of buprenorphine, either 0.15mg IV, 8mg PO, or 16mg PO. The order for the first dose administered will be fixed to the IV dose, and the subsequent doses will be randomized and counterbalanced to 8mg or 16mg PO. | Drug | 0.15mg IV Dose, 16mg PO buprenorphine, 8mg PO buprenorphine |
Primary outcome
Plasma-Concentration Curves (AUC) of Buprenorphine
Time frame: Baseline, 0.5, 1, 2, 4, 8, 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 heparinized Vacutainer tubes via a catheter in the antecubital vein at baseline, and at 0.5, 1, 2, 4, 8, and 24 hours. Samples will be centrifuged and frozen until analysis.
8 secondary outcomes
Maximum Plasma Concentration
Time frame: Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.
Time to Maximum Plasma Concentration
Time frame: Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.
Volume of Distribution
Time frame: Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.
Elimination half-life
Time frame: Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.
Total Clearance
Time frame: Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.
Pupil Size
Time frame: Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.
The Drug Effects Questionnaire
Time frame: Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.
Buccal Swab
Time frame: will be done once at the baseline visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
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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 1 study testing 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 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 23 Oct 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma-Concentration Curves (AUC) of Buprenorphine (time frame: Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.). 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 23 Oct 2025.