Substance-Related DisordersBENZORTNCT04622995
Benzodiazepines in Opiate Replacement Therapy
An observational study of Substance-Related Disorders, run by University of Stirling at 1 site in United Kingdom.
Trial summary
Drug-related deaths (DRD) are a significant and increasing public health problem in Scotland. Benzodiazepines and BZD-type substances (BZD) are increasingly implicated in DRD. In 2018, BZDs were implicated in 67% of DRD, often in combination with other illicit and prescribable substances including Opiate Replacement… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Benzodiazepine
- How many people
- 46,899 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2021to 31 Dec 2022
- Phase
- Observational
- 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
Study population: The study population includes people who received medication assisted treatment for the management of opiate / opioid addiction from community settings (e.g. community-based specialist addiction services and primary care physicians 'General Practitioners').
The cohort will consist of people who were prescribed ORT between 01/01/2010 and 31/12/2020. The definition of ORT is based on the following medications and associated British National Formulary (BNF) codes:
Chemical (BNF code): Buprenorphine Hydrochloride/Naloxone Hydrochloride (0410030B0); Buprenorphine Hydrochloride (0410030A0); Methadone Hydrochloride (0410030C0)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Utility and Safety of Benzodiazepine Prescribing Among People Receiving Opiate Replacement Therapy in Scotland (the BENZORT Study).
Drug-related deaths (DRD) are a significant and increasing public health problem in Scotland. Benzodiazepines and BZD-type substances (BZD) are increasingly implicated in DRD. In 2018, BZDs were implicated in 67% of DRD, often in combination with other illicit and prescribable substances including Opiate Replacement Therapies (ORT) such as methadone and buprenorphine.
Illicit BZD use and dependence is higher among people with other substance use disorders. 29% of patients presenting to Scottish addiction services report current illicit BZD use. There is widespread variance in approaches to the clinical management of BZD dependence among people with opioid use disorder in Scotland. Some addiction clinicians are reluctant to prescribe BZD to people on ORT, some will prescribe BZD with the primary aim of dose reduction and detoxification, others will consider longer-term maintenance prescribing whilst patients stabilise on ORT.
Read more
Previous research has identified increased risks of mortality among people taking BZD and ORT. Other work suggests that co-prescribing BZD and ORT increases patient engagement and retention in addiction treatment.
This retrospective cohort study will analyse anonymised, linked data on people who received ORT between 01/01/2010 and 31/12/2020 to explore any relationships between exposure (co-prescribing of BZD and ORT) and harms including: mortality (all-cause and DRD), hospitalisation, illicit drug use during ORT, and reduced retention in addiction care.
Read the detailed description
Scotland is experiencing a 'public health emergency' of escalating drug-related deaths (DRD) in which benzodiazepine (BZD) are increasingly implicated, often in combination with other substances (National Records of Scotland, 2019; Scottish Government, 2019).
In 2008 BZD were implicated in 26% (n=149) of DRD and were exclusively prescribable drugs such as diazepam, although the source is not known. By 2018 BZD and BZD-type drugs were implicated in 67% (792) of DRD, predominately substances not available on prescription in the United Kingdom (UK) such as etizolam and alprazolam (Xanax). We refer to these as illicit BZD.
People who use illicit BZD, of unknown constituents and potency, can inadvertently or deliberately consume megadoses of BZD many times in excess of safe therapeutic doses, often with alcohol and other drugs, which combine to increase the risk of harm and death. Rights, Respect and Recovery, the current drug and alcohol strategy, expressed Scottish Government concern regarding the increased prevalence and potency of BZD-type drugs.
People presenting to addiction services for initial assessment frequently report illicit BZD use in the month prior to assessment, an average of 2,561 (29%) per year in the past five years for which data are available. The prevalence of illicit BZD use is known to be higher among people with other substance use disorders, especially problematic opiate and/or alcohol dependence. A systematic review identified a high prevalence (typically >40%) among people on Opiate Replacement Therapy (ORT).
The picture of BZD prescribing among people on ORT is complex and evolving. Previous work shows that BZD prescribing among ORT patients is associated with increased harms including mortality, but conversely protective factors such as increased engagement in care. Scottish addiction specialists have confirmed that some addiction services are exploring maintenance prescribing to reduce the risks associated with illicit BZD use among ORT patients. However clinical guidance does not currently provide a framework for this. Evidence of patient safety and other outcomes from BZD prescribing in the context of ORT is sparse and conflicting. A 2018 Cochrane review concluded "it is not possible to draw firm conclusions regarding pharmacological interventions to facilitate BZD discontinuation in chronic BZD users". Recent UK public health alerts have highlighted the need for caution and additional monitoring when co-prescribing BZD and ORT, and the need for improved harm reduction advice regarding the risk of illicit BZD. Addiction clinicians have indicated there has been disagreement among certifying pathologists regarding the role of benzodiazepines in DRD.
There is a need to understand patterns of, and outcomes from, BZD prescribing among ORT patients in Scotland to inform safe and effective clinical practice, address problematic BZD use in the content of poly-drug use, and reduce the risk of harms including mortality among people who use drugs (PWUD).
- Conditions
- Substance-Related Disorders
- Being tested
- Benzodiazepine
- Keywords
- Benzodiazepine, Opiate Replacement Treatment, Drug-Related Death, Overdose
- Medical subject headings
- Substance-Related Disorders, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenzodiazepineDrug
Also called Valium, Diazepam
Benzodiazepine prescribing
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Patients prescribed opiate replacement therapy plus a benzodiazepine. Receives: Drug: Benzodiazepine | |
| Unexposed | Patients prescribed opiate replacement therapy with no benzodiazepine prescribing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Death from any cause
Measured: From enrollment to end December 2020
Secondary outcomes (5)
Drug-related death
Fatal drug overdose
Measured: From enrollment to end December 2020
Drug overdose (non-fatal)
Non-fatal drug overdose
Measured: From enrollment to end December 2020
Hospitalisation
Admission to hospital from any cause
Measured: From enrollment to end December 2020
Evidence of illicit drug use during Opiate Substitution Therapy
Evidence of illicit drug use during Opiate Substitution Therapy
Measured: From enrollment to end December 2020
Retention in care
Retention in specialist addiction care for substance use disorder(s)
Measured: From enrollment to end December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Aug 2021
- Primary completion31 Mar 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 46,899 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stirling
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Research Scotland
- Responsible party
- Principal investigator, Joe Schofield, University of Stirling
- Investigators
- Joe Schofield, MPH, Principal investigator, University of Stirling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622995
- Sponsor's protocol ID
- BENZORT
- Acronym
- BENZORT
- Status last verified
- Mar 2023
- First submitted
- 3 Nov 2020
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baandrup L, Ebdrup BH, Rasmussen JO, Lindschou J, Gluud C, Glenthoj BY. Pharmacological interventions for benzodiazepine discontinuation in chronic benzodiazepine users. Cochrane Database Syst Rev. 2018 Mar 15;3(3):CD011481. doi: 10.1002/14651858.CD011481.pub2.
PubMed 29543325Bakker A, Streel E. Benzodiazepine maintenance in opiate substitution treatment: Good or bad? A retrospective primary care case-note review. J Psychopharmacol. 2017 Jan;31(1):62-66. doi: 10.1177/0269881116675508. Epub 2016 Dec 14.
PubMed 28072037Chen KW, Berger CC, Forde DP, D'Adamo C, Weintraub E, Gandhi D. Benzodiazepine use and misuse among patients in a methadone program. BMC Psychiatry. 2011 May 19;11:90. doi: 10.1186/1471-244X-11-90.
PubMed 21595945Cornish R, Macleod J, Strang J, Vickerman P, Hickman M. Risk of death during and after opiate substitution treatment in primary care: prospective observational study in UK General Practice Research Database. BMJ. 2010 Oct 26;341:c5475. doi: 10.1136/bmj.c5475.
PubMed 20978062Macleod J, Steer C, Tilling K, Cornish R, Marsden J, Millar T, Strang J, Hickman M. Prescription of benzodiazepines, z-drugs, and gabapentinoids and mortality risk in people receiving opioid agonist treatment: Observational study based on the UK Clinical Practice Research Datalink and Office for National Statistics death records. PLoS Med. 2019 Nov 26;16(11):e1002965. doi: 10.1371/journal.pmed.1002965. eCollection 2019 Nov.
PubMed 31770388McCowan C, Kidd B, Fahey T. Factors associated with mortality in Scottish patients receiving methadone in primary care: retrospective cohort study. BMJ. 2009 Jun 16;338:b2225. doi: 10.1136/bmj.b2225.
PubMed 19535400Park TW, Larochelle MR, Saitz R, Wang N, Bernson D, Walley AY. Associations between prescribed benzodiazepines, overdose death and buprenorphine discontinuation among people receiving buprenorphine. Addiction. 2020 May;115(5):924-932. doi: 10.1111/add.14886. Epub 2020 Jan 20.
PubMed 31916306Votaw VR, Geyer R, Rieselbach MM, McHugh RK. The epidemiology of benzodiazepine misuse: A systematic review. Drug Alcohol Depend. 2019 Jul 1;200:95-114. doi: 10.1016/j.drugalcdep.2019.02.033. Epub 2019 May 7.
PubMed 31121495Scottish Government. (2019). Statistics show highest ever level of drug deaths. Scottish Government. Edinburgh. Retrieved from https://news.gov.scot/news/statistics-show-highest-ever-level-of-drug-deaths
Scottish Government. (2018). Rights, Respect and Recovery. Edinburgh. Retrieved from https://www.gov.scot/binaries/content/documents/govscot/publications/strategy-plan/2018/11/rights-respect-recovery/documents/00543437-pdf/00543437-pdf/govscot%3Adocument/00543437.pdf
Public Health England; (2020, July 24). Evidence of harm from illicit or fake benzodiazepines. Retrieved October 16, 2020, from https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103075
National Records of Scotland. (2019). Drug-related Deaths in Scotland in 2018. Edinburgh: National Records of Scotland. Retrieved from https://www.nrscotland.gov.uk/statistics-and-data/statistics/statistics-by-theme/vital-events/deaths/drug-related-deaths-in-scotland/2018
Medicines and Healthcare products Regulatory Agency. (2020, March 18). Benzodiazepines and opioids: reminder of risk of potentially fatal respiratory depression. Retrieved October 16, 2020, from https://www.gov.uk/drug-safety-update/benzodiazepines-and-opioids-reminder-of-risk-of-potentially-fatal-respiratory-depression
Johnson, C. F., Barnsdale, L. R., & McAuley, A. (2016). Investigating the role of benzodiazepines in drug-related mortality: a systematic review undertaken on behalf of the Scottish National Forum on Drug-Related Deaths. Retrieved from https://www.scotpho.org.uk/media/1159/scotpho160209-investigating-the-role-of-benzodiazepines-in-drug-related-mortality.pdf
Information Services Division. (2020). Scottish Drug Misuse Database: Overview of Initial Assessments for Specialist Drug Treatment 2018/19. Edinburgh. Retrieved from https://beta.isdscotland.org/find-publications-and-data/lifestyle-and-behaviours/substance-use/scottish-drug-misuse-database/3-march-2020/
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Utility and Safety of Benzodiazepine Prescribing Among People Receiving Opiate Replacement Therapy in Scotland (the BENZORT Study).
- ClinicalTrials.gov ID
- NCT04622995
- Acronym / sponsor ID
- BENZORT / BENZORT
- Conditions
- Substance-Related Disorders
- Keywords
- Benzodiazepine, Opiate Replacement Treatment, Drug-Related Death, Overdose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46,899 participants (actual)
- Lead sponsor
- University of StirlingUniversity, hospital or other
- Collaborators
- NHS Research Scotland
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Nov 2020 (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.
Drug-related deaths (DRD) are a significant and increasing public health problem in Scotland. Benzodiazepines and BZD-type substances (BZD) are increasingly implicated in DRD. In 2018, BZDs were implicated in 67% of DRD, often in combination with other illicit and prescribable substances including Opiate Replacement Therapies (ORT) such as methadone and buprenorphine.
Illicit BZD use and dependence is higher among people with other substance use disorders. 29% of patients presenting to Scottish addiction services report current illicit BZD use. There is widespread variance in approaches to the clinical management of BZD dependence among people with opioid use disorder in Scotland. Some addiction clinicians are reluctant to prescribe BZD to people on ORT, some will prescribe BZD with the primary aim of dose reduction and detoxification, others will consider longer-term maintenance prescribing whilst patients stabilise on ORT.
Previous research has identified increased risks of mortality among people taking BZD and ORT. Other work suggests that co-prescribing BZD and ORT increases patient engagement and retention in addiction treatment.
This retrospective cohort study will analyse anonymised, linked data on people who received ORT between 01/01/2010 and 31/12/2020 to explore any relationships between exposure (co-prescribing of BZD and ORT) and harms including: mortality (all-cause and DRD), hospitalisation, illicit drug use during ORT, and reduced retention in addiction care.
Detailed description
Scotland is experiencing a 'public health emergency' of escalating drug-related deaths (DRD) in which benzodiazepine (BZD) are increasingly implicated, often in combination with other substances (National Records of Scotland, 2019; Scottish Government, 2019).
In 2008 BZD were implicated in 26% (n=149) of DRD and were exclusively prescribable drugs such as diazepam, although the source is not known. By 2018 BZD and BZD-type drugs were implicated in 67% (792) of DRD, predominately substances not available on prescription in the United Kingdom (UK) such as etizolam and alprazolam (Xanax). We refer to these as illicit BZD.
People who use illicit BZD, of unknown constituents and potency, can inadvertently or deliberately consume megadoses of BZD many times in excess of safe therapeutic doses, often with alcohol and other drugs, which combine to increase the risk of harm and death. Rights, Respect and Recovery, the current drug and alcohol strategy, expressed Scottish Government concern regarding the increased prevalence and potency of BZD-type drugs.
People presenting to addiction services for initial assessment frequently report illicit BZD use in the month prior to assessment, an average of 2,561 (29%) per year in the past five years for which data are available. The prevalence of illicit BZD use is known to be higher among people with other substance use disorders, especially problematic opiate and/or alcohol dependence. A systematic review identified a high prevalence (typically >40%) among people on Opiate Replacement Therapy (ORT).
The picture of BZD prescribing among people on ORT is complex and evolving. Previous work shows that BZD prescribing among ORT patients is associated with increased harms including mortality, but conversely protective factors such as increased engagement in care. Scottish addiction specialists have confirmed that some addiction services are exploring maintenance prescribing to reduce the risks associated with illicit BZD use among ORT patients. However clinical guidance does not currently provide a framework for this. Evidence of patient safety and other outcomes from BZD prescribing in the context of ORT is sparse and conflicting. A 2018 Cochrane review concluded "it is not possible to draw firm conclusions regarding pharmacological interventions to facilitate BZD discontinuation in chronic BZD users". Recent UK public health alerts have highlighted the need for caution and additional monitoring when co-prescribing BZD and ORT, and the need for improved harm reduction advice regarding the risk of illicit BZD. Addiction clinicians have indicated there has been disagreement among certifying pathologists regarding the role of benzodiazepines in DRD.
There is a need to understand patterns of, and outcomes from, BZD prescribing among ORT patients in Scotland to inform safe and effective clinical practice, address problematic BZD use in the content of poly-drug use, and reduce the risk of harms including mortality among people who use drugs (PWUD).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Drug: BenzodiazepinePatients prescribed opiate replacement therapy plus a benzodiazepine. |
| Unexposed | – | –Patients prescribed opiate replacement therapy with no benzodiazepine prescribing. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes people who received medication assisted treatment for the management of opiate / opioid addiction from community settings (e.g. community-based specialist addiction services and primary care physicians 'General Practitioners').
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 |
|---|---|---|
| BenzodiazepineAlso: Valium, DiazepamBenzodiazepine prescribing | Drug | Exposed |
Primary outcome
All-cause mortality
Time frame: From enrollment to end December 2020
Death from any cause
5 secondary outcomes
Drug-related death
Time frame: From enrollment to end December 2020
Drug overdose (non-fatal)
Time frame: From enrollment to end December 2020
Hospitalisation
Time frame: From enrollment to end December 2020
Evidence of illicit drug use during Opiate Substitution Therapy
Time frame: From enrollment to end December 2020
Retention in care
Time frame: From enrollment to end December 2020
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 9 Mar 2023.
- Background: PubMed 29543325Baandrup L, Ebdrup BH, Rasmussen JO, Lindschou J, Gluud C, Glenthoj BY. Pharmacological interventions for benzodiazepine discontinuation in chronic benzodiazepine users. Cochrane Database Syst Rev. 2018 Mar 15;3(3):CD011481. doi: 10.1002/14651858.CD011481.pub2.
- Background: PubMed 28072037Bakker A, Streel E. Benzodiazepine maintenance in opiate substitution treatment: Good or bad? A retrospective primary care case-note review. J Psychopharmacol. 2017 Jan;31(1):62-66. doi: 10.1177/0269881116675508. Epub 2016 Dec 14.
- Background: PubMed 21595945Chen KW, Berger CC, Forde DP, D'Adamo C, Weintraub E, Gandhi D. Benzodiazepine use and misuse among patients in a methadone program. BMC Psychiatry. 2011 May 19;11:90. doi: 10.1186/1471-244X-11-90.
- Background: PubMed 20978062Cornish R, Macleod J, Strang J, Vickerman P, Hickman M. Risk of death during and after opiate substitution treatment in primary care: prospective observational study in UK General Practice Research Database. BMJ. 2010 Oct 26;341:c5475. doi: 10.1136/bmj.c5475.
- Background: PubMed 31770388Macleod J, Steer C, Tilling K, Cornish R, Marsden J, Millar T, Strang J, Hickman M. Prescription of benzodiazepines, z-drugs, and gabapentinoids and mortality risk in people receiving opioid agonist treatment: Observational study based on the UK Clinical Practice Research Datalink and Office for National Statistics death records. PLoS Med. 2019 Nov 26;16(11):e1002965. doi: 10.1371/journal.pmed.1002965. eCollection 2019 Nov.
- Background: PubMed 19535400McCowan C, Kidd B, Fahey T. Factors associated with mortality in Scottish patients receiving methadone in primary care: retrospective cohort study. BMJ. 2009 Jun 16;338:b2225. doi: 10.1136/bmj.b2225.
- Background: PubMed 31916306Park TW, Larochelle MR, Saitz R, Wang N, Bernson D, Walley AY. Associations between prescribed benzodiazepines, overdose death and buprenorphine discontinuation among people receiving buprenorphine. Addiction. 2020 May;115(5):924-932. doi: 10.1111/add.14886. Epub 2020 Jan 20.
- Background: PubMed 31121495Votaw VR, Geyer R, Rieselbach MM, McHugh RK. The epidemiology of benzodiazepine misuse: A systematic review. Drug Alcohol Depend. 2019 Jul 1;200:95-114. doi: 10.1016/j.drugalcdep.2019.02.033. Epub 2019 May 7.
- BackgroundScottish Government. (2019). Statistics show highest ever level of drug deaths. Scottish Government. Edinburgh. Retrieved from https://news.gov.scot/news/statistics-show-highest-ever-level-of-drug-deaths
- BackgroundScottish Government. (2018). Rights, Respect and Recovery. Edinburgh. Retrieved from https://www.gov.scot/binaries/content/documents/govscot/publications/strategy-plan/2018/11/rights-respect-recovery/documents/00543437-pdf/00543437-pdf/govscot%3Adocument/00543437.pdf
- BackgroundPublic Health England; (2020, July 24). Evidence of harm from illicit or fake benzodiazepines. Retrieved October 16, 2020, from https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103075
- BackgroundNational Records of Scotland. (2019). Drug-related Deaths in Scotland in 2018. Edinburgh: National Records of Scotland. Retrieved from https://www.nrscotland.gov.uk/statistics-and-data/statistics/statistics-by-theme/vital-events/deaths/drug-related-deaths-in-scotland/2018
- 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.
Joe Schofield, MPH principal investigator
University of Stirling
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance-Related Disorders, run by University of Stirling at 1 site in United Kingdom.
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 9 Mar 2023. 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 Kingdom. 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?
All-cause mortality (time frame: From enrollment to end December 2020). 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 NCT04622995, which also lists 17 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 9 Mar 2023; AzTrials last refreshed its copy on 29 Oct 2026.