Opioid UseNCT03684681
The Navigator Trial
A study testing Peer Navigator Intervention and Social Work Intervention in people with Opioid Use and Opioid Dependence, run by Rhode Island Hospital at 1 site in United States.
Trial summary
In this study, the investigators will investigate if there is a better intervention for patients who present to the emergency department with an overdose or with symptoms consistent with drug use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Opioid Dependence, Opioid Abuse
- What is being tested?
- Peer Navigator Intervention and Social Work Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2018to 30 Nov 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- 18 years of age or older
- Treatment for an opioid overdose or identified as having had an opioid overdose in the past 12 months or are being treated for a visit related to illicit opioid use (e.g., abscess, opioid withdrawal)
- Able to provide informed consent.
Who cannot join
- Less than 18 years of age
- Previously enrolled in the study
- In police custody
- Incarcerated
- Live outside of Rhode Island
- Pregnant
- Critically ill or injured
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02905
About this study
In this study, the investigators will investigate if there is a better intervention for patients who present to the emergency department with an overdose or with symptoms consistent with drug use. There are currently two interventions that are routinely used when a patient comes to the Emergency Department with these criteria, and the investigators will compare the two. The first is when hospital social workers uses their own previous training to help people meet their goals. The second is when a person called a peer navigator, who is someone that has been in long-term drug recovery for over two years and has completed a lot of training to work with current drug users, delivers an intervention to current drug users and uses their own training and real- life experiences to help people meet their goals. The investigators hope to determine if patients have better outcomes if they work with one of these two groups.
If a patient agrees to be in the study, the research staff will randomize them (like flipping a coin) to see if they will work with a social worker or a peer navigator. The research staff will distribute a survey in RedCap and the following information will be collected: age, sex, race, type of opioid used, and history of chronic pain, depression or post-traumatic stress disorder. Once the patient is assigned to a group, they will work with their assigned interventionist for the duration of the study. After this, the research team will track the patient to see if they joined an addiction-treatment program within 30 days of when the joined the study. The study team will also track patients to see if they had additional emergency department visits, additional overdoses, and if they successfully completed a treatment program over an 18-month period.
650 patients will be enrolled into the study.
Read the detailed description
Opioid overdoses are a leading cause of death for Americans under 50 years old, with recent years recording the most opioid overdose deaths on record. US Emergency Departments (EDs) have seen a parallel increase in opioid-related visits (a 100% increase from 2005 - 2014). ED patients presenting for an overdose are at greatly elevated risk for a repeat overdose and death. Thus, an overdose-related ED visit is both a critical and opportune time to prevent recurrent opioid overdose and overdose death through increased uptake in addiction treatment. The most effective means to promote engagement in treatment following an ED visit for opioid overdose remains unknown. To address this critical evidence gap, the investigators will compare the effectiveness of two ED-based behavioral interventions to increase treatment uptake and reduce the risk of future overdose among ED patients who are at greatest risk of accidental drug-related death.
In response to RI's overdose crisis, in 2014, the state's largest ED (Rhode Island Hospital) began a proactive campaign to improve the care of overdose patients. The program includes an ED-based behavioral intervention either by in-house clinical social work staff or peer recovery support specialists ("peer navigators"). Following the introduction of these interventions in the ED, there was 10-fold increase in the proportion of patients engaging in addiction treatment within 30 days of the initial ED visit. While this preliminary data is promising, the effectiveness of the peer navigators versus the social work intervention is not known.
The investigators propose a randomized controlled trial of early ED behavioral interventions following an opioid overdose. The investigators hypothesize that peer navigation will result in greater early treatment engagement and reduction in recurrent opioid overdose compared to a standard intervention delivered by a clinical social worker.
The investigators will determine the effectiveness of peer navigation versus a standard behavioral intervention delivered in the ED to overdose patients and those at risk of recurrent opioid overdose. A total of 650 ED patients will be recruited (n=325 per arm) and followed for 18 months. Effectiveness will be measured objectively through linkage to administrative statewide databases, with two primary endpoints: (1) engagement in formal addiction treatment (e.g., inpatient services, outpatient services, medication assisted treatment (MAT)) from a licensed substance abuse treatment provider within 30 days following the ED visit, and (2) reduction in 18-month recurrent ED visits for an opioid overdose. Exploratory outcomes of interest are: overdose fatality, repeat ED visits related to opioids, and successful completion of an addiction treatment program and/or long-term retention in MAT.
The investigators will explore if there is heterogeneity of treatment effect related to patient characteristics. The investigators anticipate that there will be individuals within each treatment arm who will vary in their response to the intervention. Specifically, the investigators will examine if the effects of the interventions are modified by baseline characteristics such as age, sex, race, type of opioid used, and history of comorbid chronic pain, depression or PTSD. Understanding these factors will allow us to further optimize subsequent interventions.
- Conditions
- Opioid Use, Opioid Dependence, Opioid Abuse, Opioid-Related Disorders
- Being tested
- Peer Navigator Intervention, Social Work Intervention
- 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.
Peer Navigator InterventionBehavioural
A peer navigator delivers an intervention to current drug users and uses their own training and real- life experiences to help people meet their goals.
Social Work InterventionBehavioural
A hospital social workers uses their own previous training to help people meet their goals.
| Study group | Role | What they receive |
|---|---|---|
| Peer Navigator | Other | Current standard of care Receives: Behavioral: Peer Navigator Intervention |
| Social Worker | Other | Current standard of care Receives: Behavioral: Social Work Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants who are admitted to a formal addiction treatment program within thirty days following the initial ED visit.
Engagement in addiction treatment will be defined as the proportion who are admitted to a formal addiction treatment program within thirty days following the initial ED visit. The research team will be using BHDDH and Prescription Drug Monitoring Program (PDMP) records. The BHDDH database contains information on all admissions to publicly funded substance abuse treatment programs in the state. The RI PDMP manages a database that contains information on all prescriptions for schedule II-IV substances filled in the state. The database is updated daily; all pharmacies are required to report prescriptions within 48-hours of the fill date. All records will be linked deterministically to participant data using identifiable information (e.g., name, social security number) within the Stronghold computing environment, a HIPAA-compliant server maintained by the team at Brown University.
Measured: 30 days
The proportion of participants who are treated in any Rhode Island ED for an opioid overdose at any time during the 18-month follow-up period following the initial ED visit.
The proportion of participants who are treated in any Rhode Island ED for an opioid overdose at any time during the 18-month follow-up period following the initial ED visit, will be assessed by first accessing the electronic medical records (EMRs) of the 12 EDs in Rhode Island (RI) through the Rhode Island Quality Institute Statewide Health Information Exchange. This unified data system provides access to EMR data from all major health systems in RI, capturing repeat visits for an opioid overdose that occur in all 12 EDs in RI. Secondly the research team will query the RI Department of Health (RIDOH) Opioid 48-Hour Overdose Surveillance System which mandates all suspected opioid overdose cases presenting to an RI hospital be reported to the department within 48 hours. This data source will capture recurrent overdoses not identified by ICD codes in the unified EMR data system, and also contains additional fields of interest (e.g., pre-existing risk factors for overdose).
Measured: 18 months
Secondary outcomes (4)
Compare the the time to subsequent opioid overdose rates between groups.
The principal investigator will use Breslow's method to test if the time to subsequent opioid overdose rates differs between the groups.
Measured: 18 month
Successful completion or retention in addiction treatment
Successful completion and/or retention in addiction treatment will be defined based on discharge data collected in BHOLD and prescription refill data in the PDMP. The principal investigator will examine the time to ED visit for an opioid overdose using a Kaplan-Meier analysis. Patients will be censored at the end of the 18-month follow-up period, considered the last point of contact.
Measured: 18 month
Overdose death
Cox proportional hazards modeling will be used to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for occurrence of repeat overdose between groups. HRs will be adjusted for clinical and demographic characteristics believed to predict the outcome of opioid overdose in order to adjust for possible residual confounding and treatment-factor interactions.
Measured: 18 months
Heterogeneity of intervention effect
The principal investigator will perform stratified subgroup analyses to determine if treatment effects vary between groups of individuals.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start14 Nov 2018
- Primary completion14 May 2021
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Sponsor
- Investigators
- Francesca Beaudoin, MD, Principal investigator, Brown Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684681
- Sponsor's protocol ID
- Navigator
- Status last verified
- Jun 2022
- First submitted
- 17 Sep 2018
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chambers LC, Li Y, Hallowell BD, Langdon KJ, Samuels EA, Mahoney LA, Beaudoin FL, Marshall BDL. Effect of a peer-led emergency department behavioral intervention on non-fatal opioid overdose: 18-month outcome in the Navigator randomized controlled trial. Addiction. 2024 Dec;119(12):2116-2128. doi: 10.1111/add.16581. Epub 2024 Jul 10.
PubMed 38987890Collins AB, Baird J, Nimaja E, Ashenafi Y, Clark MA, Beaudoin FL. Experiences of patients at high risk of opioid overdose accessing emergency department and behavioral health interventions: a qualitative analysis in an urban emergency department. BMC Health Serv Res. 2023 Apr 18;23(1):370. doi: 10.1186/s12913-023-09387-7.
PubMed 37069593Beaudoin FL, Jacka BP, Li Y, Samuels EA, Hallowell BD, Peachey AM, Newman RA, Daly MM, Langdon KJ, Marshall BDL. Effect of a Peer-Led Behavioral Intervention for Emergency Department Patients at High Risk of Fatal Opioid Overdose: A Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2225582. doi: 10.1001/jamanetworkopen.2022.25582.
PubMed 35943744Jacka B, Beaudoin F, Li Y, Nimaja E, Yedinak J, Samuels E, Marshall BDL. Objective Outcome Measures in Randomized Clinical Trials of Interventions to Reduce Risk of Opioid Overdose Following Discharge From the Emergency Department: Utility of Administrative Data Linkage. J Addict Med. 2021 Apr 1;15(2):174-175. doi: 10.1097/ADM.0000000000000705. No abstract available.
PubMed 32769773Goedel WC, Marshall BDL, Samuels EA, Brinkman MG, Dettor D, Langdon KJ, Mahoney LA, Merchant RC, Nizami T, O'Toole GA, Ramsey SE, Yedinak JL, Beaudoin FL. Randomised clinical trial of an emergency department-based peer recovery support intervention to increase treatment uptake and reduce recurrent overdose among individuals at high risk for opioid overdose: study protocol for the navigator trial. BMJ Open. 2019 Nov 11;9(11):e032052. doi: 10.1136/bmjopen-2019-032052.
PubMed 31719087
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Navigator Trial
- ClinicalTrials.gov ID
- NCT03684681
- Acronym / sponsor ID
- Navigator
- Conditions
- Opioid Use, Opioid Dependence, Opioid Abuse, Opioid-Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 26 Sep 2018 (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.
In this study, the investigators will investigate if there is a better intervention for patients who present to the emergency department with an overdose or with symptoms consistent with drug use. There are currently two interventions that are routinely used when a patient comes to the Emergency Department with these criteria, and the investigators will compare the two. The first is when hospital social workers uses their own previous training to help people meet their goals. The second is when a person called a peer navigator, who is someone that has been in long-term drug recovery for over two years and has completed a lot of training to work with current drug users, delivers an intervention to current drug users and uses their own training and real- life experiences to help people meet their goals. The investigators hope to determine if patients have better outcomes if they work with one of these two groups.
If a patient agrees to be in the study, the research staff will randomize them (like flipping a coin) to see if they will work with a social worker or a peer navigator. The research staff will distribute a survey in RedCap and the following information will be collected: age, sex, race, type of opioid used, and history of chronic pain, depression or post-traumatic stress disorder. Once the patient is assigned to a group, they will work with their assigned interventionist for the duration of the study. After this, the research team will track the patient to see if they joined an addiction-treatment program within 30 days of when the joined the study. The study team will also track patients to see if they had additional emergency department visits, additional overdoses, and if they successfully completed a treatment program over an 18-month period.
650 patients will be enrolled into the study.
Detailed description
Opioid overdoses are a leading cause of death for Americans under 50 years old, with recent years recording the most opioid overdose deaths on record. US Emergency Departments (EDs) have seen a parallel increase in opioid-related visits (a 100% increase from 2005 - 2014). ED patients presenting for an overdose are at greatly elevated risk for a repeat overdose and death. Thus, an overdose-related ED visit is both a critical and opportune time to prevent recurrent opioid overdose and overdose death through increased uptake in addiction treatment. The most effective means to promote engagement in treatment following an ED visit for opioid overdose remains unknown. To address this critical evidence gap, the investigators will compare the effectiveness of two ED-based behavioral interventions to increase treatment uptake and reduce the risk of future overdose among ED patients who are at greatest risk of accidental drug-related death.
In response to RI's overdose crisis, in 2014, the state's largest ED (Rhode Island Hospital) began a proactive campaign to improve the care of overdose patients. The program includes an ED-based behavioral intervention either by in-house clinical social work staff or peer recovery support specialists ("peer navigators"). Following the introduction of these interventions in the ED, there was 10-fold increase in the proportion of patients engaging in addiction treatment within 30 days of the initial ED visit. While this preliminary data is promising, the effectiveness of the peer navigators versus the social work intervention is not known.
The investigators propose a randomized controlled trial of early ED behavioral interventions following an opioid overdose. The investigators hypothesize that peer navigation will result in greater early treatment engagement and reduction in recurrent opioid overdose compared to a standard intervention delivered by a clinical social worker.
The investigators will determine the effectiveness of peer navigation versus a standard behavioral intervention delivered in the ED to overdose patients and those at risk of recurrent opioid overdose. A total of 650 ED patients will be recruited (n=325 per arm) and followed for 18 months. Effectiveness will be measured objectively through linkage to administrative statewide databases, with two primary endpoints: (1) engagement in formal addiction treatment (e.g., inpatient services, outpatient services, medication assisted treatment (MAT)) from a licensed substance abuse treatment provider within 30 days following the ED visit, and (2) reduction in 18-month recurrent ED visits for an opioid overdose. Exploratory outcomes of interest are: overdose fatality, repeat ED visits related to opioids, and successful completion of an addiction treatment program and/or long-term retention in MAT.
The investigators will explore if there is heterogeneity of treatment effect related to patient characteristics. The investigators anticipate that there will be individuals within each treatment arm who will vary in their response to the intervention. Specifically, the investigators will examine if the effects of the interventions are modified by baseline characteristics such as age, sex, race, type of opioid used, and history of comorbid chronic pain, depression or PTSD. Understanding these factors will allow us to further optimize subsequent interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Navigator | Other | Behavioral: Peer Navigator InterventionCurrent standard of care |
| Social Worker | Other | Behavioral: Social Work InterventionCurrent standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking
- 18 years of age or older
- Treatment for an opioid overdose or identified as having had an opioid overdose in the past 12 months or are being treated for a visit related to illicit opioid use (e.g., abscess, opioid withdrawal)
- Able to provide informed consent.
Key exclusion criteria (7 listed)
- Less than 18 years of age
- Previously enrolled in the study
- In police custody
- Incarcerated
- Live outside of Rhode Island
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 |
|---|---|---|
| Peer Navigator InterventionA peer navigator delivers an intervention to current drug users and uses their own training and real- life experiences to help people meet their goals. | Behavioural | Peer Navigator |
| Social Work InterventionA hospital social workers uses their own previous training to help people meet their goals. | Behavioural | Social Worker |
Primary outcome
The proportion of participants who are admitted to a formal addiction treatment program within thirty days following the initial ED visit.
Time frame: 30 days
Engagement in addiction treatment will be defined as the proportion who are admitted to a formal addiction treatment program within thirty days following the initial ED visit. The research team will be using BHDDH and Prescription Drug Monitoring Program (PDMP) records. The BHDDH database contains information on all admissions to publicly funded substance abuse treatment programs in the state. The RI PDMP manages a database that contains information on all prescriptions for schedule II-IV substances filled in the state. The database is updated daily; all pharmacies are required to report prescriptions within 48-hours of the fill date. All records will be linked deterministically to participant data using identifiable information (e.g., name, social security number) within the Stronghold computing environment, a HIPAA-compliant server maintained by the team at Brown University.
The proportion of participants who are treated in any Rhode Island ED for an opioid overdose at any time during the 18-month follow-up period following the initial ED visit.
Time frame: 18 months
The proportion of participants who are treated in any Rhode Island ED for an opioid overdose at any time during the 18-month follow-up period following the initial ED visit, will be assessed by first accessing the electronic medical records (EMRs) of the 12 EDs in Rhode Island (RI) through the Rhode Island Quality Institute Statewide Health Information Exchange. This unified data system provides access to EMR data from all major health systems in RI, capturing repeat visits for an opioid overdose that occur in all 12 EDs in RI. Secondly the research team will query the RI Department of Health (RIDOH) Opioid 48-Hour Overdose Surveillance System which mandates all suspected opioid overdose cases presenting to an RI hospital be reported to the department within 48 hours. This data source will capture recurrent overdoses not identified by ICD codes in the unified EMR data system, and also contains additional fields of interest (e.g., pre-existing risk factors for overdose).
4 secondary outcomes
Compare the the time to subsequent opioid overdose rates between groups.
Time frame: 18 month
Successful completion or retention in addiction treatment
Time frame: 18 month
Overdose death
Time frame: 18 months
Heterogeneity of intervention effect
Time frame: 18 months
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 22 Jun 2023.
- Derived from this study: PubMed 38987890Chambers LC, Li Y, Hallowell BD, Langdon KJ, Samuels EA, Mahoney LA, Beaudoin FL, Marshall BDL. Effect of a peer-led emergency department behavioral intervention on non-fatal opioid overdose: 18-month outcome in the Navigator randomized controlled trial. Addiction. 2024 Dec;119(12):2116-2128. doi: 10.1111/add.16581. Epub 2024 Jul 10.
- Derived from this study: PubMed 37069593Collins AB, Baird J, Nimaja E, Ashenafi Y, Clark MA, Beaudoin FL. Experiences of patients at high risk of opioid overdose accessing emergency department and behavioral health interventions: a qualitative analysis in an urban emergency department. BMC Health Serv Res. 2023 Apr 18;23(1):370. doi: 10.1186/s12913-023-09387-7.
- Derived from this study: PubMed 35943744Beaudoin FL, Jacka BP, Li Y, Samuels EA, Hallowell BD, Peachey AM, Newman RA, Daly MM, Langdon KJ, Marshall BDL. Effect of a Peer-Led Behavioral Intervention for Emergency Department Patients at High Risk of Fatal Opioid Overdose: A Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2225582. doi: 10.1001/jamanetworkopen.2022.25582.
- Derived from this study: PubMed 32769773Jacka B, Beaudoin F, Li Y, Nimaja E, Yedinak J, Samuels E, Marshall BDL. Objective Outcome Measures in Randomized Clinical Trials of Interventions to Reduce Risk of Opioid Overdose Following Discharge From the Emergency Department: Utility of Administrative Data Linkage. J Addict Med. 2021 Apr 1;15(2):174-175. doi: 10.1097/ADM.0000000000000705. No abstract available.
- Derived from this study: PubMed 31719087Goedel WC, Marshall BDL, Samuels EA, Brinkman MG, Dettor D, Langdon KJ, Mahoney LA, Merchant RC, Nizami T, O'Toole GA, Ramsey SE, Yedinak JL, Beaudoin FL. Randomised clinical trial of an emergency department-based peer recovery support intervention to increase treatment uptake and reduce recurrent overdose among individuals at high risk for opioid overdose: study protocol for the navigator trial. BMJ Open. 2019 Nov 11;9(11):e032052. doi: 10.1136/bmjopen-2019-032052.
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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.
Francesca Beaudoin, MD principal investigator
Brown Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Navigator Intervention and Social Work Intervention in people with Opioid Use and Opioid Dependence, run by Rhode Island 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 7 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 22 Jun 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 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.
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?
The proportion of participants who are admitted to a formal addiction treatment program within thirty days following the initial ED visit. (time frame: 30 days). 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 NCT03684681, which also lists 5 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 22 Jun 2023.