OverdoseSOONERNCT03821649
SOONER Feasibility Study Protocol
A study testing SOONER Training and Naloxone Kit Kit and Community or Hospital-Based Training in people with Overdose, run by Unity Health Toronto at 4 sites in Canada.
Trial summary
Opioid Overdose Education and Naloxone Distribution programs (OEND) involve training and equipping people who are likely to be bystanders to opioid overdose to recognize and respond to opioid-related emergencies by activating emergency services, delivering basic life support and administering naloxone. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overdose
- What is being tested?
- SOONER Training and Naloxone Kit Kit and Community or Hospital-Based Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesCanada
- Study dates
- 23 Jan 2019to 10 Dec 2020
- Phase
- Interventional
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Participants are eligible by meeting any one or more of the following:
- Have a history of taking opioids at recognized 'high doses' (whether by prescription or otherwise, defined as >100mg morphine equivalent per day).
- Live with or is in frequent contact with others who use opioids or heroin.
- Have required emergency care for opioid overdose previously.
- Are enrolled in opioid agonist treatment programs (or has been in the last 6 months), including methadone or buprenorphine maintenance programs, particularly at high risk periods such as induction or discharge.
- Are being released from prison, and have a history of non-medical opioid use.
- Are receiving prescription opioid therapy with risk factors for adverse effects, including relevant comorbidities, co-prescriptions of benzodiazepines or other sedatives, concomitant ongoing alcohol use, or high dose prescription opioid therapy.
- Uses non-medical opioids, injects opioids, or acquires opioids from sources other than a pharmacy or healthcare setting.
Exclusion Criteria: Participants are ineligible by meeting any one or more of the following:
- Have a community do not resuscitate order.
- Have a terminal illness, end-of-life care, or illness likely to result in death within the study period.
- Have no mode of contact or follow-up.
- Plan to move away from Toronto during the study period.
- Have insufficient English language skills to participate in the study.
- Are an active or previously practicing healthcare professional or professional first responder (e.g.: firefighter, police officer, lifeguard, industrial first responder).
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Inner City Family Health Team
Toronto, Ontario
St Michael's Hospital Emergency Department
Toronto, Ontario
St Micheal's Health Centre at 410
Toronto, Ontario
St Micheal's Hospital Rapid Access Addictions Medicine Clinic
Toronto
About this study
Official title: Protocol for a Mixed Methods Feasibility Study for the Surviving Opioid Overdose With Naloxone Education and Resuscitation (SOONER) Trial
Opioid Overdose Education and Naloxone Distribution programs (OEND) involve training and equipping people who are likely to be bystanders to opioid overdose to recognize and respond to opioid-related emergencies by activating emergency services, delivering basic life support and administering naloxone. The goal of the Surviving Opioid Overdose with Naloxone Education and Resuscitation (SOONER) trial is to identify if point-of-care OEND increases rates of satisfactory bystander resuscitative performance to simulated opioid overdose in comparison with the existing standard of care. Recruitment and retention of participants at risk of overdose, and the acceptability of the simulated overdose outcome may challenge the feasibility of the SOONER trial. The primary objective is to identify if an integrated participant recruitment and retention strategy can recruit approximately 28 eligible participants within 4 weeks and maintain less than 50% attrition in the context of a randomized trial on point-of-care OEND and simulated overdose resuscitation performance in family practice, emergency department, and addictions settings in Toronto, Ontario. After the initial 28 participants, we are continuing to recruit up to 50 more participants in a bridging phase that leads into the full trial.
Read the detailed description
Deaths from opioid overdose represent an important and expanding global public health epidemic. Opioid Overdose Education and Naloxone Distribution programs (OEND) involve training and equipping people who are likely to witness overdose to recognize these emergencies and administer essential first aid interventions including naloxone, a widely known and effective competitive opioid antagonist. Policymakers and practitioners have called for expanded access to OEND programs in clinical settings such as emergency departments, family practice, and addiction medicine clinics, or "point-of-care OEND". Point-of-care OEND would improve access to this potentially life-saving intervention. Simple and effective point-of-care OEND tools are a prerequisite for the successful translation of this intervention into general ambulatory settings, including family practice, addiction medicine and psychiatry clinics, and emergency departments. The investigators plan to conduct a randomized trial to evaluate the educational effectiveness of a novel point-of-care OEND kit in a simulated opioid overdose, in comparison with existing community- and hospital-based OEND programs.
Conducting trials among people who use drugs or who are likely to witness overdose involves several well-documented scientific, logistical, and bioethical challenges. These challenges contribute to the persistent under-evaluation of interventions to enhance the health of this marginalized population, and threats to study validity when retention rates are low.
Recruitment, retention and attrition rates could alter the study timelines, logistics and costs for the proposed trial. A feasibility study is needed to evaluate and refine an integrated participant recruitment and retention strategy, develop expected retention rates, establish the local acceptability of study procedures in recruitment sites, and reconsider study design and analysis if required. A feasibility study will also permit the evaluation of basic randomization and data collection procedures.
The primary objective of this feasibility study is to identify if an integrated participant recruitment and retention strategy can recruit approximately 28 eligible participants within 4 weeks and maintain less than 50% attrition in the context of a randomized trial on point-of-care OEND and simulated overdose resuscitation performance in family practice, emergency department, and addiction medicine settings at St. Michael's Hospital, and in family practice at the Inner City Family Health Team.
- Conditions
- Overdose
- Being tested
- SOONER Training and Naloxone Kit Kit, Community or Hospital-Based Training
- Keywords
- Education, Naloxone, Opioid, Overdose, Resuscitation
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOONER Training and Naloxone Kit KitBehavioural
Participants are shown our unique overdose response education video and given the associated kit to take home.
Community or Hospital-Based TrainingBehavioural
Referral to standard of care for Naloxone training
| Study group | Role | What they receive |
|---|---|---|
| SOONER Training and Naloxone Kit | Experimental | Participants in this arm will be shown the SOONER overdose response training video at the time of recruitment and given the SOONER Naloxone kit to take home. Receives: Behavioral: SOONER Training and Naloxone Kit Kit |
| Community or Hospital-Based Training | Active comparator | Control arm - participants in this arm will be referred to the standard of care for Naloxone training. This standard of care includes community-based OEND programs and/or an existing hospital-based OEND program.. Receives: Behavioral: Community or Hospital-Based Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant recruitment rate (participants recruited in 4 weeks)
Approximately 28 participants are recruited within 4 weeks.
The recruitment and retention strategy will be deemed "feasible" if BOTH of the following conditions are met:
(A) approximately 28 participants are recruited within 4 weeks, AND (B) there is less than 50% attrition at the underlying study's outcome simulation.
Measured: 4 weeks
Participant attrition at the underlying study's outcome simulation
less than 50% attrition at the underlying study's outcome simulation.
Primary outcome description: The recruitment and retention strategy will be deemed "feasible" if BOTH of the following conditions are met:
(A) approximately 28 participants are recruited within 4 weeks, AND (B) there is less than 50% attrition at the underlying study's outcome simulation.
Measured: 4-6 weeks
Secondary outcomes (3)
Site recruitment rates
Rate of participant recruitment in each of the family practice, emergency department, and addiction medicine sites associated with a single academic health care centre.
Measured: 28 days
Participant retention rates
Comparison of retention rate between intervention and control arms
Measured: 4-6 weeks
Descriptions of study process problems
Semi-structured interviews with study participants and unstructured verbal and written feedback from study and recruitment site staff concerning challenges and opportunities for improving any study processes (including participant recruitment, randomization, implementation of the intervention and control, retention, follow-up, outcome assessment and data collection).
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start23 Jan 2019
- Primary completion1 Mar 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for OverdoseStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- OCAD University, Toronto Public Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821649
- Sponsor's protocol ID
- 1
- Acronym
- SOONER
- Status last verified
- May 2022
- First submitted
- 17 Jan 2019
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
United Nations Office on Drugs and Crime, World Health Organization. Discussion paper UNODC/WHO 2013: Opioid overdose: preventing and reducing opioid overdose mortality. 2013; Available at: http://www.unodc.org/docs/treatment/overdose.pdf. Accessed 04/23, 2014. Archived by WebCite© at http://www.webcitation.org/6U3qbjl2E)
Clark AK, Wilder CM, Winstanley EL. A systematic review of community opioid overdose prevention and naloxone distribution programs. J Addict Med. 2014 May-Jun;8(3):153-63. doi: 10.1097/ADM.0000000000000034.
PubMed 24874759Doyon S, Aks SE, Schaeffer S. Expanding access to naloxone in the United States. J Med Toxicol. 2014 Dec;10(4):431-4. doi: 10.1007/s13181-014-0432-1. No abstract available.
PubMed 25316516Beletsky L, Ruthazer R, Macalino GE, Rich JD, Tan L, Burris S. Physicians' knowledge of and willingness to prescribe naloxone to reverse accidental opiate overdose: challenges and opportunities. J Urban Health. 2007 Jan;84(1):126-36. doi: 10.1007/s11524-006-9120-z.
PubMed 17146712Coffin PO, Fuller C, Vadnai L, Blaney S, Galea S, Vlahov D. Preliminary evidence of health care provider support for naloxone prescription as overdose fatality prevention strategy in New York City. J Urban Health. 2003 Jun;80(2):288-90. doi: 10.1093/jurban/jtg031.
PubMed 12791804Meyers K, Webb A, Frantz J, Randall M. What does it take to retain substance-abusing adolescents in research protocols? Delineation of effort required, strategies undertaken, costs incurred, and 6-month post-treatment differences by retention difficulty. Drug Alcohol Depend. 2003 Jan 24;69(1):73-85. doi: 10.1016/s0376-8716(02)00252-1.
PubMed 12536068Parsons JA, Markowitz B, Thomas R, Norris K, Charles M, King C, Sellen K, Campbell DM, Leece P, Klaiman M, Chapman L, Hopkins S, Shahin R, Handford C, Stergiopoulos V, Morrison LJ, Strike C, Orkin AM; SOONER investigators. The opportunity to save a life: A qualitative study of a point-of-care overdose education and naloxone distribution intervention. PLoS One. 2025 Jun 25;20(6):e0326495. doi: 10.1371/journal.pone.0326495. eCollection 2025.
PubMed 40560908Orkin AM, Charles M, Norris K, Thomas R, Chapman L, Wright A, Campbell DM, Handford C, Klaiman M, Hopkins S, Shahin R, Thorpe K, Juni P, Parsons J, Sellen K, Goso N, Hunt R, Leece P, Morrison LJ, Stergiopoulos V, Turner S, Strike C. Mixed methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) trial. Resusc Plus. 2021 May 14;6:100131. doi: 10.1016/j.resplu.2021.100131. eCollection 2021 Jun.
PubMed 34223388Orkin A, Campbell D, Handford C, Hopkins S, Klaiman M, Leece P, Parsons JA, Shahin R, Strike C, Thorpe K, Sellen K, Milos G, Wright A, Charles M, Sniderman R, Morrison L; SOONER Investigators. Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial. BMJ Open. 2019 Nov 12;9(11):e029436. doi: 10.1136/bmjopen-2019-029436.
PubMed 31722937
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Mixed Methods Feasibility Study for the Surviving Opioid Overdose With Naloxone Education and Resuscitation (SOONER) Trial
- ClinicalTrials.gov ID
- NCT03821649
- Acronym / sponsor ID
- SOONER / 1
- Conditions
- Overdose
- Keywords
- Education, Naloxone, Opioid, Overdose, Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- OCAD University, Toronto Public Health
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 30 Jan 2019 (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.
Opioid Overdose Education and Naloxone Distribution programs (OEND) involve training and equipping people who are likely to be bystanders to opioid overdose to recognize and respond to opioid-related emergencies by activating emergency services, delivering basic life support and administering naloxone. The goal of the Surviving Opioid Overdose with Naloxone Education and Resuscitation (SOONER) trial is to identify if point-of-care OEND increases rates of satisfactory bystander resuscitative performance to simulated opioid overdose in comparison with the existing standard of care. Recruitment and retention of participants at risk of overdose, and the acceptability of the simulated overdose outcome may challenge the feasibility of the SOONER trial. The primary objective is to identify if an integrated participant recruitment and retention strategy can recruit approximately 28 eligible participants within 4 weeks and maintain less than 50% attrition in the context of a randomized trial on point-of-care OEND and simulated overdose resuscitation performance in family practice, emergency department, and addictions settings in Toronto, Ontario. After the initial 28 participants, we are continuing to recruit up to 50 more participants in a bridging phase that leads into the full trial.
Detailed description
Deaths from opioid overdose represent an important and expanding global public health epidemic. Opioid Overdose Education and Naloxone Distribution programs (OEND) involve training and equipping people who are likely to witness overdose to recognize these emergencies and administer essential first aid interventions including naloxone, a widely known and effective competitive opioid antagonist. Policymakers and practitioners have called for expanded access to OEND programs in clinical settings such as emergency departments, family practice, and addiction medicine clinics, or "point-of-care OEND". Point-of-care OEND would improve access to this potentially life-saving intervention. Simple and effective point-of-care OEND tools are a prerequisite for the successful translation of this intervention into general ambulatory settings, including family practice, addiction medicine and psychiatry clinics, and emergency departments. The investigators plan to conduct a randomized trial to evaluate the educational effectiveness of a novel point-of-care OEND kit in a simulated opioid overdose, in comparison with existing community- and hospital-based OEND programs.
Conducting trials among people who use drugs or who are likely to witness overdose involves several well-documented scientific, logistical, and bioethical challenges. These challenges contribute to the persistent under-evaluation of interventions to enhance the health of this marginalized population, and threats to study validity when retention rates are low.
Recruitment, retention and attrition rates could alter the study timelines, logistics and costs for the proposed trial. A feasibility study is needed to evaluate and refine an integrated participant recruitment and retention strategy, develop expected retention rates, establish the local acceptability of study procedures in recruitment sites, and reconsider study design and analysis if required. A feasibility study will also permit the evaluation of basic randomization and data collection procedures.
The primary objective of this feasibility study is to identify if an integrated participant recruitment and retention strategy can recruit approximately 28 eligible participants within 4 weeks and maintain less than 50% attrition in the context of a randomized trial on point-of-care OEND and simulated overdose resuscitation performance in family practice, emergency department, and addiction medicine settings at St. Michael's Hospital, and in family practice at the Inner City Family Health Team.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOONER Training and Naloxone Kit | Experimental | Behavioral: SOONER Training and Naloxone Kit KitParticipants in this arm will be shown the SOONER overdose response training video at the time of recruitment and given the SOONER Naloxone kit to take home. |
| Community or Hospital-Based Training | Active comparator | Behavioral: Community or Hospital-Based TrainingControl arm - participants in this arm will be referred to the standard of care for Naloxone training. This standard of care includes community-based OEND programs and/or an existing hospital-based OEND program.. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| SOONER Training and Naloxone Kit KitParticipants are shown our unique overdose response education video and given the associated kit to take home. | Behavioural | SOONER Training and Naloxone Kit |
| Community or Hospital-Based TrainingReferral to standard of care for Naloxone training | Behavioural | Community or Hospital-Based Training |
Primary outcome
Participant recruitment rate (participants recruited in 4 weeks)
Time frame: 4 weeks
Approximately 28 participants are recruited within 4 weeks. The recruitment and retention strategy will be deemed "feasible" if BOTH of the following conditions are met: (A) approximately 28 participants are recruited within 4 weeks, AND (B) there is less than 50% attrition at the underlying study's outcome simulation.
Participant attrition at the underlying study's outcome simulation
Time frame: 4-6 weeks
less than 50% attrition at the underlying study's outcome simulation. Primary outcome description: The recruitment and retention strategy will be deemed "feasible" if BOTH of the following conditions are met: (A) approximately 28 participants are recruited within 4 weeks, AND (B) there is less than 50% attrition at the underlying study's outcome simulation.
3 secondary outcomes
Site recruitment rates
Time frame: 28 days
Participant retention rates
Time frame: 4-6 weeks
Descriptions of study process problems
Time frame: 4-6 weeks
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 May 2022.
- BackgroundUnited Nations Office on Drugs and Crime, World Health Organization. Discussion paper UNODC/WHO 2013: Opioid overdose: preventing and reducing opioid overdose mortality. 2013; Available at: http://www.unodc.org/docs/treatment/overdose.pdf. Accessed 04/23, 2014. Archived by WebCite© at http://www.webcitation.org/6U3qbjl2E)
- Background: PubMed 24874759Clark AK, Wilder CM, Winstanley EL. A systematic review of community opioid overdose prevention and naloxone distribution programs. J Addict Med. 2014 May-Jun;8(3):153-63. doi: 10.1097/ADM.0000000000000034.
- Background: PubMed 25316516Doyon S, Aks SE, Schaeffer S. Expanding access to naloxone in the United States. J Med Toxicol. 2014 Dec;10(4):431-4. doi: 10.1007/s13181-014-0432-1. No abstract available.
- Background: PubMed 17146712Beletsky L, Ruthazer R, Macalino GE, Rich JD, Tan L, Burris S. Physicians' knowledge of and willingness to prescribe naloxone to reverse accidental opiate overdose: challenges and opportunities. J Urban Health. 2007 Jan;84(1):126-36. doi: 10.1007/s11524-006-9120-z.
- Background: PubMed 12791804Coffin PO, Fuller C, Vadnai L, Blaney S, Galea S, Vlahov D. Preliminary evidence of health care provider support for naloxone prescription as overdose fatality prevention strategy in New York City. J Urban Health. 2003 Jun;80(2):288-90. doi: 10.1093/jurban/jtg031.
- Background: PubMed 12536068Meyers K, Webb A, Frantz J, Randall M. What does it take to retain substance-abusing adolescents in research protocols? Delineation of effort required, strategies undertaken, costs incurred, and 6-month post-treatment differences by retention difficulty. Drug Alcohol Depend. 2003 Jan 24;69(1):73-85. doi: 10.1016/s0376-8716(02)00252-1.
- Derived from this study: PubMed 40560908Parsons JA, Markowitz B, Thomas R, Norris K, Charles M, King C, Sellen K, Campbell DM, Leece P, Klaiman M, Chapman L, Hopkins S, Shahin R, Handford C, Stergiopoulos V, Morrison LJ, Strike C, Orkin AM; SOONER investigators. The opportunity to save a life: A qualitative study of a point-of-care overdose education and naloxone distribution intervention. PLoS One. 2025 Jun 25;20(6):e0326495. doi: 10.1371/journal.pone.0326495. eCollection 2025.
- Derived from this study: PubMed 34223388Orkin AM, Charles M, Norris K, Thomas R, Chapman L, Wright A, Campbell DM, Handford C, Klaiman M, Hopkins S, Shahin R, Thorpe K, Juni P, Parsons J, Sellen K, Goso N, Hunt R, Leece P, Morrison LJ, Stergiopoulos V, Turner S, Strike C. Mixed methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) trial. Resusc Plus. 2021 May 14;6:100131. doi: 10.1016/j.resplu.2021.100131. eCollection 2021 Jun.
- Derived from this study: PubMed 31722937Orkin A, Campbell D, Handford C, Hopkins S, Klaiman M, Leece P, Parsons JA, Shahin R, Strike C, Thorpe K, Sellen K, Milos G, Wright A, Charles M, Sniderman R, Morrison L; SOONER Investigators. Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial. BMJ Open. 2019 Nov 12;9(11):e029436. doi: 10.1136/bmjopen-2019-029436.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOONER Training and Naloxone Kit Kit and Community or Hospital-Based Training in people with Overdose, run by Unity Health Toronto at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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.
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?
Participant recruitment rate (participants recruited in 4 weeks) (time frame: 4 weeks). 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 NCT03821649, which also lists 9 linked publications.
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 May 2022; AzTrials last refreshed its copy on 27 Oct 2026.