SuicidePARSNCT03166709
Preventing Addiction Related Suicide (PARS)
A study testing Preventing Addiction Related Suicide (PARS) and Intensive Outpatient Program standard session in people with Suicide and Substance-Related Disorders, run by University of Washington at 16 sites in United States.
Trial summary
The goal of this study is to evaluate the effectiveness and utility of the investigator's National Institute on Drug Abuse (NIDA) R21 developed "Preventing Addiction Related Suicide" (PARS) program by utilizing a novel stepped wedge design to evaluate PARS as a selected prevention program to increase help-seeking by… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide, Substance-Related Disorders
- What is being tested?
- Preventing Addiction Related Suicide (PARS) and Intensive Outpatient Program standard session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 906 participants
- Where
- 16 sitesUnited States
- Study dates
- 11 Oct 2017to 28 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrolled client in one of the community treatment settings
- Over 18 years of age (no maximum age)
- Ability to understand written and spoken English
Who cannot join
- 1. Any clinical medical/psychiatric condition, severity of that condition, or life situation that in the opinion of the counselors or Drs. Comtois or Ries would compromise safe and voluntary study participation (e.g., psychosis, custody conflict). This is expected to be a rare circumstance and will be known prior to the recruitment session. If a counselor does not want someone involved, they will not be. If counselor is unsure, Dr. Comtois or Ries will facilitate decision with counselor ahead of time to assist in the decision.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Lakeside-Milam
Auburn, Washington, 98002
Lakeside-Milam
Edmonds, Washington, 98026
Evergreen Recovery Centers
Everett, Washington, 98201
Lakeside-Milam
Everett, Washington, 98204
Olalla Recovery Centers
Gig Harbor, Washington, 98335
Lakeside-Milam
Issaquah, Washington, 98027
Lakeside-Milam
Kirkland, Washington, 98033
Northwest Integrated Health
Lakewood, Washington, 98499
Evergreen Recovery Centers
Lynnwood, Washington, 98036
Lakeside-Milam
Puyallup, Washington, 98371
Northwest Integrated Health
Puyallup, Washington, 98374
Lakeside-Milam
Renton, Washington, 98055
Lakeside-Milam
Seattle, Washington, 98102
THS
Seattle, Washington, 98104
Lakeside-Milam
Tacoma, Washington, 98405
Northwest Integrated Health
Tacoma, Washington, 98406
About this study
Official title: Preventing Addiction Related Suicide (PARS) - Controlled Trial of Secondary Suicide Prevention
The goal of this study is to evaluate the effectiveness and utility of the investigator's National Institute on Drug Abuse (NIDA) R21 developed "Preventing Addiction Related Suicide" (PARS) program by utilizing a novel stepped wedge design to evaluate PARS as a selected prevention program to increase help-seeking by clients in community addiction treatment.
Read the detailed description
Studies consistently show suicide and suicidal behaviors are highly related to substance use disorders (SUDs). Recent reviews find that the risk of suicide is 10-17 times higher for people using multiple drugs, injecting drugs, and for alcohol use disorders. SUDs are also related to suicidal thoughts and suicide attempts. Clients admitted for alcohol treatment report a much higher rate of lifetime suicide attempts (40-43%) than a nationally representative sample of adults (4.6%). Further, prospective data shows that individuals in addiction treatment had five times the odds of suicide attempt over five years compared to those not in treatment, emphasizing addiction treatment as a key opportunity for instituting suicide prevention strategies.
Based on Stage I guidelines for developing and adapting behavioral interventions and information from a Substance Abuse and Mental Health Services Administration (SAMHSA) Treatment Improvement Protocol (TIP50) on suicide and addiction, we developed the Preventing Addiction Related Suicide (PARS) program.
To maximize the chances of implementation, PARS was developed to be a community-friendly program with a team of community partners (i.e., administrators, counselors, clients) who advised on its scope, duration, and approach. Community leaders reviewed PARS throughout its development and pilot testing was conducted in their community treatment settings. Thus, PARS is simultaneously based on evidence-based practice and the goals and needs of community treatment settings. Importantly, PARS is a selected prevention program and not intervention for suicidality per se-it is designed for all clients in addiction treatment as a standard part of care. PARS' goal is increased help-seeking by addiction treatment clients as well as by clients' friends and family if and when they themselves become suicidal. Reaching out for help leads to care that can address and resolve suicidality. PARS is the only published selected prevention program for this high-risk population.
PARS is a psychoeducational program taught as a single three-hour module integrated into a standard group therapy-oriented Intensive Outpatient Program (IOP), the most common form of community addiction treatment. Pilot testing of PARS in three community agencies demonstrated significant post-intervention increases in accurate information about suicide and decreases in maladaptive attitudes toward suicide. These changes at post-intervention were maintained at 1-month follow-up. Even more compelling, 1-month follow-up assessments demonstrated that the likelihood of positive help seeking for suicidality doubled for the month after PARS compared to the month before. Clients were significantly more likely to ask suicidal friends (from 9% to 22%) and family (9% to 17%) to seek help as well as to seek help themselves (4% to 9%).
Given these promising Stage I results in Stage III settings, we propose a fully-powered Stage III effectiveness trial of PARS compared to Treatment-as-Usual (TAU) using a stepped wedge design with 900 clients enrolled in 15 community addiction treatment sites. We will collect outcome data post-intervention and at 1, 3, and 6 months follow-up. We propose the following research aims:
Aim 1: Compare the effectiveness of IOP integrating PARS to TAU to change beliefs about suicide and suicide prevention.
Hypothesis 1a: Clients who receive PARS will know more accurate information about suicide.
Hypothesis 1b: Clients who receive PARS will have less maladaptive attitudes about suicide.
Aim 2: Compare the effectiveness of IOP integrating PARS to TAU to increase help-seeking behaviors for clients and for clients' friends or family at risk of suicide.
Hypothesis 1c: Clients who receive PARS will show greater help-seeking for themselves and others
Aim 3: Evaluate whether changes in beliefs about suicide and suicide prevention-particularly regarding warning signs for suicide, including addiction, intoxication, and relapse, as well as beliefs that suicide is preventable when action is taken-are possible mechanisms by which PARS increases help-seeking behavior.
Hypothesis 2: The effect of PARS vs. TAU on changes in help-seeking will be mediated by improved information and attitudes.
Exploratory Aim 4: Evaluate possible clinic-level dose effects of PARS administration such that participant outcomes improve the longer PARS is implemented within clinics.
Exploratory Aim 5: Compare the effects of PARS vs. TAU on clients' suicidality and substance use in the follow-up period.
By integrating PARS into IOP group treatment, community treatment agencies are in a unique position to act as key players in the national suicide prevention strategy by providing suicide prevention information, improving attitudes regarding suicide, and increasing help-seeking skills for one of the most high-risk populations for suicide. This proposal is innovative in its focus, the development of PARS in community settings, as well as the use of a stepped wedge design.
- Conditions
- Suicide, Substance-Related Disorders
- Being tested
- Preventing Addiction Related Suicide (PARS), Intensive Outpatient Program standard session
- Medical subject headings
- Suicide, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventing Addiction Related Suicide (PARS)Behavioural
PARS is a module designed for a single session of an Intensive Outpatient Program (IOP) including a specified combination of didactic presentations and group discussions. PARS topics include: Goals and Objectives; Suicide Overview; The Strong Link Between Addiction and Suicide; Suicide Myths and Facts; Common Triggers of Suicidal Thoughts and Behaviors; Warning Signs of Suicide; Suicide Risk Factors; Suicide Protective Factors; How You Can Prevent Addiction Related Suicide; Action Steps to Take if You or Someone You Know Becomes Suicidal
Intensive Outpatient Program standard sessionBehavioural
Intensive Outpatient Program (IOP) substance abuse group session focused on depression, grief, or managing emotions. Site-specific session topic is what that IOP usually provides and was chosen by agency leads prior to start of study.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual | Active comparator | Intensive Outpatient Program (IOP) addiction treatment Receives: Behavioral: Intensive Outpatient Program standard session |
| Experimental | Experimental | Secondary Prevention Intervention (PARS) plus Treatment as Usual Receives: Behavioral: Preventing Addiction Related Suicide (PARS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PARS Help-Seeking Scale
The PARS Help-Seeking Scale consists of 4 items assessing help-seeking behavior in the context of suicidal thoughts or feelings (e.g., calling a crisis/suicide hotline) developed for our pilot trial22 based on prior suicide prevention programs. Participants reported the frequency of past-month help-seeking on behalf of self or others, including friends and family members, from "never" (=0) to "more than 3 times" (=4). Responses were summed to create a score from 0 to 16 with higher numbers indicating the better outcome of increased help-seeking.
Measured: Six months
PARS Suicide Knowledge Scale
The PARS Suicide Knowledge Scale is an 11-item measure adapted from the Staff Suicide Prevention Survey (SSPS) assessing factual understanding of suicide and closely mapped to the content of PARS. Correct responses were summed to create a score from 0 to 11 with higher scores representing the better outcome of greater suicide knowledge.
Measured: Six months
PARS Attitude Scale
The PARS Attitude Scale, adapted from the Staff Suicide Prevention Survey (SSPS), consists of 6 items evaluating maladaptive attitudes about suicide stigma and prevention. Responses on a 5-point scale from "strongly disagree" (=1) to "strongly agree" (=5) were summed to create a score from 6 to 30 where lower scores indicate a better outcome.
Measured: Six months
Secondary outcomes (1)
Suicidal Behavior Questionnaire - Revised
The Suicidal Behavior Questionnaire - Revised assesses suicide attempts, ideation, communication, and intent since the last assessment. Total score with higher indicating the worse outcome of suicide risk from lowest (3) to highest (18); non-clinical cutoff 7 and above
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start11 Oct 2017
- Primary completion28 May 2020
- Study completion28 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped wedge - 15 sites randomly divided into 5 groups which are then randomly ordered into 5 steps. Step 1 is all control. During steps 2-6 one group implements the experimental condition in assigned order until all groups are doing experimental condition.
- Masking
- None (open label)
- Enrolment
- 906 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Kate Comtois, University of Washington
- Investigators
- Katherine Anne Comtois, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166709
- Sponsor's protocol ID
- STUDY00001966
- Other IDs
- 1R01DA041486-01A1
- Acronym
- PARS
- Status last verified
- Jul 2025
- First submitted
- 22 May 2017
- Last updated
- 14 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ries RK, Livengood AL, Huh D, Kerbrat AH, Fruhbauerova M, Turner B, Comtois KA. Effectiveness of a Suicide Prevention Module for Adults in Substance Use Disorder Treatment: A Stepped-Wedge Cluster-Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e222945. doi: 10.1001/jamanetworkopen.2022.2945.
PubMed 35385090
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Addiction Related Suicide (PARS) - Controlled Trial of Secondary Suicide Prevention
- ClinicalTrials.gov ID
- NCT03166709
- Acronym / sponsor ID
- PARS / STUDY00001966
- Conditions
- Suicide, Substance-Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 906 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 25 May 2017 (actual)
- Results
- Posted 14 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the effectiveness and utility of the investigator's National Institute on Drug Abuse (NIDA) R21 developed "Preventing Addiction Related Suicide" (PARS) program by utilizing a novel stepped wedge design to evaluate PARS as a selected prevention program to increase help-seeking by clients in community addiction treatment.
Detailed description
Studies consistently show suicide and suicidal behaviors are highly related to substance use disorders (SUDs). Recent reviews find that the risk of suicide is 10-17 times higher for people using multiple drugs, injecting drugs, and for alcohol use disorders. SUDs are also related to suicidal thoughts and suicide attempts. Clients admitted for alcohol treatment report a much higher rate of lifetime suicide attempts (40-43%) than a nationally representative sample of adults (4.6%). Further, prospective data shows that individuals in addiction treatment had five times the odds of suicide attempt over five years compared to those not in treatment, emphasizing addiction treatment as a key opportunity for instituting suicide prevention strategies.
Based on Stage I guidelines for developing and adapting behavioral interventions and information from a Substance Abuse and Mental Health Services Administration (SAMHSA) Treatment Improvement Protocol (TIP50) on suicide and addiction, we developed the Preventing Addiction Related Suicide (PARS) program.
To maximize the chances of implementation, PARS was developed to be a community-friendly program with a team of community partners (i.e., administrators, counselors, clients) who advised on its scope, duration, and approach. Community leaders reviewed PARS throughout its development and pilot testing was conducted in their community treatment settings. Thus, PARS is simultaneously based on evidence-based practice and the goals and needs of community treatment settings. Importantly, PARS is a selected prevention program and not intervention for suicidality per se-it is designed for all clients in addiction treatment as a standard part of care. PARS' goal is increased help-seeking by addiction treatment clients as well as by clients' friends and family if and when they themselves become suicidal. Reaching out for help leads to care that can address and resolve suicidality. PARS is the only published selected prevention program for this high-risk population.
PARS is a psychoeducational program taught as a single three-hour module integrated into a standard group therapy-oriented Intensive Outpatient Program (IOP), the most common form of community addiction treatment. Pilot testing of PARS in three community agencies demonstrated significant post-intervention increases in accurate information about suicide and decreases in maladaptive attitudes toward suicide. These changes at post-intervention were maintained at 1-month follow-up. Even more compelling, 1-month follow-up assessments demonstrated that the likelihood of positive help seeking for suicidality doubled for the month after PARS compared to the month before. Clients were significantly more likely to ask suicidal friends (from 9% to 22%) and family (9% to 17%) to seek help as well as to seek help themselves (4% to 9%).
Given these promising Stage I results in Stage III settings, we propose a fully-powered Stage III effectiveness trial of PARS compared to Treatment-as-Usual (TAU) using a stepped wedge design with 900 clients enrolled in 15 community addiction treatment sites. We will collect outcome data post-intervention and at 1, 3, and 6 months follow-up. We propose the following research aims:
Aim 1: Compare the effectiveness of IOP integrating PARS to TAU to change beliefs about suicide and suicide prevention.
Hypothesis 1a: Clients who receive PARS will know more accurate information about suicide.
Hypothesis 1b: Clients who receive PARS will have less maladaptive attitudes about suicide.
Aim 2: Compare the effectiveness of IOP integrating PARS to TAU to increase help-seeking behaviors for clients and for clients' friends or family at risk of suicide.
Hypothesis 1c: Clients who receive PARS will show greater help-seeking for themselves and others
Aim 3: Evaluate whether changes in beliefs about suicide and suicide prevention-particularly regarding warning signs for suicide, including addiction, intoxication, and relapse, as well as beliefs that suicide is preventable when action is taken-are possible mechanisms by which PARS increases help-seeking behavior.
Hypothesis 2: The effect of PARS vs. TAU on changes in help-seeking will be mediated by improved information and attitudes.
Exploratory Aim 4: Evaluate possible clinic-level dose effects of PARS administration such that participant outcomes improve the longer PARS is implemented within clinics.
Exploratory Aim 5: Compare the effects of PARS vs. TAU on clients' suicidality and substance use in the follow-up period.
By integrating PARS into IOP group treatment, community treatment agencies are in a unique position to act as key players in the national suicide prevention strategy by providing suicide prevention information, improving attitudes regarding suicide, and increasing help-seeking skills for one of the most high-risk populations for suicide. This proposal is innovative in its focus, the development of PARS in community settings, as well as the use of a stepped wedge design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge - 15 sites randomly divided into 5 groups which are then randomly ordered into 5 steps. Step 1 is all control. During steps 2-6 one group implements the experimental condition in assigned order until all groups are doing experimental condition.
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual | Active comparator | Behavioral: Intensive Outpatient Program standard sessionIntensive Outpatient Program (IOP) addiction treatment |
| Experimental | Experimental | Behavioral: Preventing Addiction Related Suicide (PARS)Secondary Prevention Intervention (PARS) plus Treatment as Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Enrolled client in one of the community treatment settings
- Over 18 years of age (no maximum age)
- Ability to understand written and spoken English
Key exclusion criteria (1 listed)
- 1. Any clinical medical/psychiatric condition, severity of that condition, or life situation that in the opinion of the counselors or Drs. Comtois or Ries would compromise safe and voluntary study participation (e.g., psychosis, custody conflict). This is expected to be a rare circumstance and will be known prior to the recruitment session. If a counselor does not want someone involved, they will not be. If counselor is unsure, Dr. Comtois or Ries will facilitate decision with counselor ahead of time to assist in the decision.
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 |
|---|---|---|
| Preventing Addiction Related Suicide (PARS)PARS is a module designed for a single session of an Intensive Outpatient Program (IOP) including a specified combination of didactic presentations and group discussions. PARS topics include: Goals and Objectives; Suicide Overview; The Strong Link Between Addiction and Suicide; Suicide Myths and Facts; Common Triggers of Suicidal Thoughts and Behaviors; Warning Signs of Suicide; Suicide Risk Factors; Suicide Protective Factors; How You Can Prevent Addiction Related Suicide; Action Steps to Take if You or Someone You Know Becomes Suicidal | Behavioural | Experimental |
| Intensive Outpatient Program standard sessionIntensive Outpatient Program (IOP) substance abuse group session focused on depression, grief, or managing emotions. Site-specific session topic is what that IOP usually provides and was chosen by agency leads prior to start of study. | Behavioural | Treatment As Usual |
Primary outcome
PARS Help-Seeking Scale
Time frame: Six months
The PARS Help-Seeking Scale consists of 4 items assessing help-seeking behavior in the context of suicidal thoughts or feelings (e.g., calling a crisis/suicide hotline) developed for our pilot trial22 based on prior suicide prevention programs. Participants reported the frequency of past-month help-seeking on behalf of self or others, including friends and family members, from "never" (=0) to "more than 3 times" (=4). Responses were summed to create a score from 0 to 16 with higher numbers indicating the better outcome of increased help-seeking.
PARS Suicide Knowledge Scale
Time frame: Six months
The PARS Suicide Knowledge Scale is an 11-item measure adapted from the Staff Suicide Prevention Survey (SSPS) assessing factual understanding of suicide and closely mapped to the content of PARS. Correct responses were summed to create a score from 0 to 11 with higher scores representing the better outcome of greater suicide knowledge.
PARS Attitude Scale
Time frame: Six months
The PARS Attitude Scale, adapted from the Staff Suicide Prevention Survey (SSPS), consists of 6 items evaluating maladaptive attitudes about suicide stigma and prevention. Responses on a 5-point scale from "strongly disagree" (=1) to "strongly agree" (=5) were summed to create a score from 6 to 30 where lower scores indicate a better outcome.
1 secondary outcome
Suicidal Behavior Questionnaire - Revised
Time frame: Six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35385090Ries RK, Livengood AL, Huh D, Kerbrat AH, Fruhbauerova M, Turner B, Comtois KA. Effectiveness of a Suicide Prevention Module for Adults in Substance Use Disorder Treatment: A Stepped-Wedge Cluster-Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e222945. doi: 10.1001/jamanetworkopen.2022.2945.
- 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.
Katherine Anne Comtois, PhD, MPH principal investigator
University of Washington
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventing Addiction Related Suicide (PARS) and Intensive Outpatient Program standard session in people with Suicide and Substance-Related Disorders, run by University of Washington at 16 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 1 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 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PARS Help-Seeking Scale (time frame: Six months). The study lists 3 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 NCT03166709, which also lists 1 linked publication.
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 Aug 2025.