Opioid Use DisorderPhase 4NCT06323824
Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment.
A Phase 4 study testing Methadone and Buprenorphine (BUP) in people with Opioid Use Disorder, run by Yale University at 6 sites in United States.
Trial summary
The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Methadone and Buprenorphine (BUP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 6 sitesUnited States
- Study dates
- 4 Jun 2024to Dec 2028
- Phase
- Phase 4
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older;
- Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for OUD;
- Are initiating a new MOUD treatment episode
Who cannot join
- Have been prescribed (and ingested) or been administered more than 72 hours of MOUD in the 7 days prior to randomization as a "bridge" to the new OUD treatment episode. Such MOUD may include prescribed (and ingested) or administered medically managed withdrawal (aka detoxification).
- Known contraindication to methadone or BUP
- Unwilling to pursue or continue pre-natal care or pregnancy counseling if determined pregnant by urine human chorionic gonadotropin (hCG) testing at the screening assessment
- Be actively suicidal or severely cognitively impaired (e.g., dementia, untreated psychosis) precluding informed consent as determined by site clinician
- Current severe comorbid substance use disorder requiring residential or inpatient treatment services as determined by site clinician
- Be unable to provide locator information including one or more contacts in addition to themselves
Show all 11Show fewer
- Be unwilling to follow study procedures (e.g., unwilling to receive treatment from site clinician, use the study pharmacy, unwilling to be randomized to BUP or methadone, or will be unavailable for the follow-up assessments) including allowing the researchers to access their record in the EMR and state's prescription drug monitoring program
- Have previously enrolled in CTN-0131
- Currently enrolled in another research study which will conflict with study procedures
- Are currently in jail, prison or other overnight facility as required by a court of law or have pending legal action that could prevent participation in study activities
- Unable to conduct research assessments in English as determined by Site PI or their designee.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Officed Based Addiction Treatment Program, Boston Medical Center
Boston, Massachusetts, 02118
Emily Oot, 857-283-7620, EMBOSS@bmc.org
Zoe Weinstein, MD
- Recruiting
Rapid Start Clinic, Kaiser Permanente Colorado
Denver, Colorado, 80205
Jennifer Barrow, (303)-739-3666, EMBOSS@kp.org
Ingrid Binswanger, MD
- Recruiting
Marshall University Division of Addiction Sciences P.R.O.A.C.T
Huntington, West Virginia, 25703
Brynn M Taylor, 740-302-0845, taylor975@marshall.edu
Zachary Hansen, MD
- Recruiting
Hennepin Healthcare Addiction Medicine
Minneapolis, Minnesota, 55415
Fiona Giles, (763) 568-2785, EMBOSSstudy@bermancenter.org
Gavin Bart, MD
- Recruiting
Highland Hospital Bridge Clinic at Alameda Health System
Oakland, California, 94602
Jhoselyn Pineda, (510)214-3649, emboss.ctn0131@gmail.com
Monish Ullal, MD
- Recruiting
Outpatient Buprenorphine Induction Clinic, University of California, San Francisco
San Francisco, California, 94103
Kristina Toma, 415-254-0398, EMBOSS@ucsf.edu
Paula Lum, MD
About this study
Official title: Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment - A Pragmatic Hybrid Effectiveness/Implementation Trial
The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone.
Read the detailed description
This study is a randomized, pragmatic hybrid type 1 effectiveness/implementation multisite (approximately 6 sites) trial to determine whether office-based methadone with pharmacy administration and/or dispensing or buprenorphine (BUP) results in greater treatment retention in approximately 600 patients with opioid use disorder (OUD). This trial will also identify implementation barriers, facilitators and acceptability at the patient, provider and health-systems level for office-based methadone with pharmacy administration and/or dispensing.
An ancillary extended study was added to this trial in January of 2026. A sub-set of current participants that were receiving office based methadone as of day 168 of the parent study will continue to be followed for other pre-specified outcomes.
- Conditions
- Opioid Use Disorder
- Being tested
- Methadone, Buprenorphine (BUP)
- Keywords
- Opioid Use Disorder, Methadone, 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.
MethadoneDrug
Drug: Methadone
Possible formulations:
10 and 50 mg tablets
Buprenorphine (BUP)Drug
Drug: Buprenorphine (BUP)
Possible formulations:
- Buprenorphine, 225 mcg to 24 mg, 225 mcg to 32 mg per day,
- Buprenorphine (Extended release), 300 mg q 28 days (Sublocade), 100 mg q 28 days (Sublocade), 8 mg q 7 days (Brixadi), 16 mg q 7 days (Brixadi), 24 mg q 7 days (Brixadi), 32 mg q 7 days (Brixadi), 64 mg q 28 days (Brixadi), 96 mg q 28 days (Brixadi), 128 mg q 28 days (Brixadi),
| Study group | Role | What they receive |
|---|---|---|
| Office-based methadone | Experimental | Under special Drug Enforcement Administration (DEA) exception, Clinician prescribes methadone and oral methadone is administered and/or dispensed at a pharmacy which also has an exception to do so. All randomized controlled trial (RCT) participants are offered additional behavioral treatments (e.g., individual, group, telehealth, phone-based). Receives: Drug: Methadone |
| Office-based buprenorphine (BUP) | Active comparator | Clinician prescribes BUP formulations that are dispensed at a pharmacy or administered in the office (e.g., extended-release formulations). All RCT participants are offered additional behavioral treatments (e.g., individual, group, telehealth, phone-based). Receives: Drug: Buprenorphine (BUP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days of continuous treatment with site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants.
This measure is based on PDMP data for methadone and non-injectable buprenorphine and EMR data for injectable buprenorphine formulations
Measured: up to Day 168
Secondary outcomes (17)
Number of self-reported continuous treatment days in any FDA-approved formulation of MOUD treatment during the 168 days post-randomization.
This measure is assessed using the MOUD Calendar Based Recall Recall Instruments.
Measured: up to Day 168
Number of self-reported continuous treatment days in formal OUD treatment, according to American Society of Addiction Medicine (ASAM) levels of care 1-4, during the 168 days post-randomization.
This measure is assessed using one or more of the following:
The Health Services Utilization instrument, a brief structured interview regarding health care utilization (inpatient and outpatient) collecting information on the type and amount of services received, Timeline Followback Medications, MOUD Calendar Based Recall, and Treatment Dates instruments.
Measured: up to Day 168
Total number of days receiving any FDA-approved MOUD formulation during the 168 days post-randomization.
This measure is assessed using EMR (for injectable MOUD formulations) and PDMP data.
Measured: up to Day 168
The longest duration of continuous treatment episode with MOUD, as randomized, during the 168 days post randomization.
This measure is based on PDMP and/or EMR data.
Measured: up to Day 168
Total number of days receiving methadone or buprenorphine, during the 168 days post-randomization.
This measure is assessed using EMR (for injectable MOUD formulations) and PDMP data.
Measured: up to Day 168
Total number of days of self-reported non-prescribed opioid use during each 28-day assessment period.
This measure is assessed by the Opioid Use Calendar Based Recall instruments.
Measured: up to Day 168
Total number of days of self-reported non-prescribed stimulant use during each 28-day assessment period.
This measure is assessed by the Timeline Followback instrument.
Measured: up to Day 168
Total number of days of self-reported non-prescribed benzodiazepine use during each 28-day assessment period.
This measure is assessed by the Timeline Followback instrument.
Measured: up to Day 168
Urine toxicology
Total number of monthly (28 days) urines negative for non-prescribed opioids during the 168 days post-randomization. Non-prescribed opioids will be determined using the Opioid Use Calendar Based Recall instrument.
Measured: up to Day 168
Participant satisfaction with MOUD
Proportion of RCT participants who report at the assessment scheduled to be collected on day 28 that the medication they received was at least "Somewhat helpful" on the Satisfaction with MOUD Provider Scale instrument.
Measured: up to Day 168
Total number of self-reported overdose events per total number of participant days at risk.
The Overdose Calendar Recall instrument collects overdose events.
Measured: up to Day 168
Total number of self-reported injection drug use related events during each 28-day assessment period.
Assessment of Infectious or Other Complications of Injection Drug Use assess for skin abscesses, ulcers , cellulitis, osteoarticular septic arthritis, osteomyelitis, epidural infection , endovascular, new injection-related viral infections diagnosis of Hepatitis or HIV.
Measured: Up to Day 168
Mean score Pain measured using Pain, Enjoyment of Life and General Activity (PEG) Scale (PEG-3)
Mean scores on the PEG-3 instrument over time. The PEG-3 instrument is collected every 28 days. The mean score is the average of the three 0-10 rated items. Total score range 0-10. Higher scores indicate worse pain.
Measured: Up to Day 168
Total number of self-reported days with acute care utilization (ED or hospitalization) during each 28-day assessment period.
The Health Services Utilization instrument is a brief, structured interview regarding health care utilization (inpatient and outpatient) collecting information on the type and amount of services received. This includes ED visits, hospitalizations, primary medical care visits (excluding those for BUP treatment) and self-help sources of support (e.g., NA). Also assessed are receipt of formal and informal addiction and mental health treatment services RCT participants might have received outside the study interventions.
Measured: Up to Day 168
Total number of behavioral counseling service visits attended per participant during each 28-day assessment period.
Assessed by EMR extraction and the Health Services Utilization.
Measured: Up to Day 168
Total number of planned prescriber visits attended during each 28-day assessment period.
Assessed by EMR extraction.
Measured: Up to Day 168
Pharmacist practice fidelity
Assessed by MOUD Visit Checklist completion over time. The MOUD Visit Checklist collects clinical activities that might be performed by a pharmacist at each pharmacy, such as performing medication reconciliation; conducting safety assessments, adverse effects of methadone, recent overdose events, checking the patient's controlled medications prescription status using the PDMP before dispensing methadone; providing patient education/counseling; communicating with the clinician regarding any concern; and administering one methadone dose at the pharmacy and/or dispensing methadone according to the prescription.
Measured: Up to Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start4 Jun 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (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 Yale UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The comparative effectiveness of two strategies to address retention in medication for opioid use disorder (MOUD) treatment will be tested over a 168-day period. Behavioral treatments offered to patients are designed to be similar across the two medication conditions. Office-based methadone where the clinician prescribes methadone and oral methadone is administered and/or dispensed at a pharmacy. Providers and Randomized Control Trial (RCT) participants will have flexibility to use behavioral and pharmacological services as clinically indicated. Office-based buprenorphine (BUP) where the clinician prescribes BUP formulations that are dispensed at a pharmacy or administered in the office (e.g., extended-release formulations). Providers and RCT participants will have flexibility to use behavioral and pharmacological services as clinically indicated.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), The Emmes Company, LLC, University of California, San Francisco, Boston Medical Center (BMC), Hennepin Healthcare Research Institute, Alameda Health System, Marshall Health, Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- David Fiellin, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323824
- Sponsor's protocol ID
- 2000033271
- Other IDs
- CTN-0131, 5UG1DA015831-21
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The National Institute on Drug Abuse (NIDA) Data Share web site is an electronic environment that allows data from completed clinical trials to be distributed to investigators and the public in order to promote new research, encourage further analyses, and disseminate information to the community. Secondary analyses produced from data sharing multiply the scientific contribution of the original research. NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers to expedite the translation of research results into knowledge, products and procedures to improve human health.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment - A Pragmatic Hybrid Effectiveness/Implementation Trial
- ClinicalTrials.gov ID
- NCT06323824
- Acronym / sponsor ID
- 2000033271
- Conditions
- Opioid Use Disorder
- Keywords
- Opioid Use Disorder, Methadone, Buprenorphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), The Emmes Company, LLC, University of California, San Francisco, Boston Medical Center (BMC), Hennepin Healthcare Research Institute, Alameda Health System, Marshall Health, Kaiser Permanente
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Mar 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 purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone.
Detailed description
This study is a randomized, pragmatic hybrid type 1 effectiveness/implementation multisite (approximately 6 sites) trial to determine whether office-based methadone with pharmacy administration and/or dispensing or buprenorphine (BUP) results in greater treatment retention in approximately 600 patients with opioid use disorder (OUD). This trial will also identify implementation barriers, facilitators and acceptability at the patient, provider and health-systems level for office-based methadone with pharmacy administration and/or dispensing.
An ancillary extended study was added to this trial in January of 2026. A sub-set of current participants that were receiving office based methadone as of day 168 of the parent study will continue to be followed for other pre-specified outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The comparative effectiveness of two strategies to address retention in medication for opioid use disorder (MOUD) treatment will be tested over a 168-day period. Behavioral treatments offered to patients are designed to be similar across the two medication conditions. Office-based methadone where the clinician prescribes methadone and oral methadone is administered and/or dispensed at a pharmacy. Providers and Randomized Control Trial (RCT) participants will have flexibility to use behavioral and pharmacological services as clinically indicated. Office-based buprenorphine (BUP) where the clinician prescribes BUP formulations that are dispensed at a pharmacy or administered in the office (e.g., extended-release formulations). Providers and RCT participants will have flexibility to use behavioral and pharmacological services as clinically indicated.
| Arm | Type | Receives |
|---|---|---|
| Office-based methadone | Experimental | Drug: MethadoneUnder special Drug Enforcement Administration (DEA) exception, Clinician prescribes methadone and oral methadone is administered and/or dispensed at a pharmacy which also has an exception to do so. All randomized controlled trial (RCT) participants are offered additional behavioral treatments (e.g., individual, group, telehealth, phone-based). |
| Office-based buprenorphine (BUP) | Active comparator | Drug: Buprenorphine (BUP)Clinician prescribes BUP formulations that are dispensed at a pharmacy or administered in the office (e.g., extended-release formulations). All RCT participants are offered additional behavioral treatments (e.g., individual, group, telehealth, phone-based). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older;
- Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for OUD;
- Are initiating a new MOUD treatment episode
Key exclusion criteria (11 listed)
- Have been prescribed (and ingested) or been administered more than 72 hours of MOUD in the 7 days prior to randomization as a "bridge" to the new OUD treatment episode. Such MOUD may include prescribed (and ingested) or administered medically managed withdrawal (aka detoxification).
- Known contraindication to methadone or BUP
- Unwilling to pursue or continue pre-natal care or pregnancy counseling if determined pregnant by urine human chorionic gonadotropin (hCG) testing at the screening assessment
- Be actively suicidal or severely cognitively impaired (e.g., dementia, untreated psychosis) precluding informed consent as determined by site clinician
- Current severe comorbid substance use disorder requiring residential or inpatient treatment services as determined by site clinician
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 |
|---|---|---|
| MethadoneDrug: Methadone Possible formulations: 10 and 50 mg tablets | Drug | Office-based methadone |
| Buprenorphine (BUP)Drug: Buprenorphine (BUP) Possible formulations: A. Buprenorphine, 225 mcg to 24 mg, 225 mcg to 32 mg per day, B. Buprenorphine (Extended release), 300 mg q 28 days (Sublocade), 100 mg q 28 days (Sublocade), 8 mg q 7 days (Brixadi), 16 mg q 7 days (Brixadi), 24 mg q 7 days (Brixadi), 32 mg q 7 days (Brixadi), 64 mg q 28 days (Brixadi), 96 mg q 28 days (Brixadi), 128 mg q 28 days (Brixadi), | Drug | Office-based buprenorphine (BUP) |
Primary outcome
Number of days of continuous treatment with site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants.
Time frame: up to Day 168
This measure is based on PDMP data for methadone and non-injectable buprenorphine and EMR data for injectable buprenorphine formulations
17 secondary outcomes
Number of self-reported continuous treatment days in any FDA-approved formulation of MOUD treatment during the 168 days post-randomization.
Time frame: up to Day 168
Number of self-reported continuous treatment days in formal OUD treatment, according to American Society of Addiction Medicine (ASAM) levels of care 1-4, during the 168 days post-randomization.
Time frame: up to Day 168
Total number of days receiving any FDA-approved MOUD formulation during the 168 days post-randomization.
Time frame: up to Day 168
The longest duration of continuous treatment episode with MOUD, as randomized, during the 168 days post randomization.
Time frame: up to Day 168
Total number of days receiving methadone or buprenorphine, during the 168 days post-randomization.
Time frame: up to Day 168
Total number of days of self-reported non-prescribed opioid use during each 28-day assessment period.
Time frame: up to Day 168
Total number of days of self-reported non-prescribed stimulant use during each 28-day assessment period.
Time frame: up to Day 168
Total number of days of self-reported non-prescribed benzodiazepine use during each 28-day assessment period.
Time frame: up to Day 168
Urine toxicology
Time frame: up to Day 168
Participant satisfaction with MOUD
Time frame: up to Day 168
Total number of self-reported overdose events per total number of participant days at risk.
Time frame: up to Day 168
Total number of self-reported injection drug use related events during each 28-day assessment period.
Time frame: Up to Day 168
Mean score Pain measured using Pain, Enjoyment of Life and General Activity (PEG) Scale (PEG-3)
Time frame: Up to Day 168
Total number of self-reported days with acute care utilization (ED or hospitalization) during each 28-day assessment period.
Time frame: Up to Day 168
Total number of behavioral counseling service visits attended per participant during each 28-day assessment period.
Time frame: Up to Day 168
Total number of planned prescriber visits attended during each 28-day assessment period.
Time frame: Up to Day 168
Pharmacist practice fidelity
Time frame: Up to Day 168
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 14 Sep 2026.
- Individual participant dataSharing planned: Yes. The National Institute on Drug Abuse (NIDA) Data Share web site is an electronic environment that allows data from completed clinical trials to be distributed to investigators and the public in order to promote new research, encourage further analyses, and disseminate information to the community. Secondary analyses produced from data sharing multiply the scientific contribution of the original research. NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers to expedite the translation of research results into knowledge, products and procedures to improve human health.
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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.
David Fiellin, MD principal investigator
Yale University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methadone and Buprenorphine (BUP) in people with Opioid Use Disorder, run by Yale University at 6 sites 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 3 inclusion and 11 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Jessica Research Associate (203-785-6821, j.mckenzie@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days of continuous treatment with site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants. (time frame: up to Day 168). 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 14 Sep 2026.