Alcohol Use DisorderRC-LinkNCT06479681
A Peer Recovery Coaching Intervention for Hospitalized Alcohol Use Disorder Patients
A study testing Peer recovery coaching (PRC) and Brief Intervention (SBIRT) in people with Alcohol Use Disorder, run by Clemson University at 2 sites in United States.
Trial summary
The project objective is to rigorously evaluate the effectiveness of a peer recovery coaching intervention (called RC-Link) in patients hospitalized with medical complications from alcohol use on recovery outcomes guided by the new NIAAA definition of recovery, examine mechanisms of heavy drinking using daily… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Peer recovery coaching (PRC) and Brief Intervention (SBIRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Apr 2024to 2 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Live within 50 miles of the recruitment and plan to stay in the area for at least 6 months
- Current DSM-V criteria for moderate or severe AUD (measured by a score of ≥4 on the DSM-V Checklist)
- Hospitalized with a principal, primary, or secondary AUD-related diagnosis
Who cannot join
- Unable to provide informed consent
- Patients referred to hospice during hospitalization
- Women who are pregnant
- Comorbid diagnosis or at-risk for methamphetamine, cocaine, or opioid use disorder as determined by a score of ≥4 on the National Institute on Drug Abuse (NIDA) Modified Assist v3.0
- Current suicidal ideation
- Incarcerated at time of hospitalization
Show all 10Show fewer
- Currently has a peer recovery coach
- Toxicology screen positive for opiates, cocaine, or methamphetamine
- Experiencing moderate/severe alcohol withdrawal based on physician assessment
- Psychotic disorders or bipolar disorder documented in chart
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Greenville Memorial Hospital
Greenville, South Carolina, 29605
Kaileigh Byrne, PhD, 864-656-3935, kaileib@clemson.edu
Alain Litwin, MD, 864-430-0911, alain.litwin@prismahealth.org
- Recruiting
Oconee Memorial Hospital
Seneca, South Carolina, 29672
Kaileigh Byrne, PhD, 3153504368, kaileib@clemson.edu
About this study
The project objective is to rigorously evaluate the effectiveness of a peer recovery coaching intervention (called RC-Link) in patients hospitalized with medical complications from alcohol use on recovery outcomes guided by the new NIAAA definition of recovery, examine mechanisms of heavy drinking using daily ecological momentary assessment (EMA), and determine the program's cost-effectiveness using an randomized controlled trial (RCT) design. The primary outcomes are frequency of heavy drinking, biopsychosocial functioning, and remission from AUD.
Read the detailed description
Alcohol Use Disorder (AUD) is the third leading cause of preventable deaths in U.S. and accounts for over 10% of U.S. hospital admissions. Treatment for this population often fails to address the underlying cause of the hospitalization: the AUD. Patients hospitalized with alcohol-related medical complications tend to have high-risk for recurrence of alcohol-related medical problems, high rates of hospital readmissions, and poor recovery outcomes. Methods that promote long-term recovery care are needed. Inpatient linkage to peer recovery coaching may bridge this gap in care by providing a method of continued care for AUD recovery that offers flexibility in recovery pathways, peer modeling opportunities, and strong social support. Pilot study results demonstrated the feasibility of inpatient linkage to peer recovery coaching and showed evidence of decreased alcohol consumption, increased engagement in treatment and recovery support programs, and decreased emergency department visits. However, pilot study sample size, outcomes, and methods were limited. This proposal seeks to overcome these limitations and build on these preliminary results by: using ecological momentary assessments, measuring recovery using the new NIAAA definition, examining cost-effectiveness, assessing alcohol consumption using an additional objective measure (breath alcohol content levels), and examining social support and self-efficacy as potential mechanisms of effectiveness. This proposal will rigorously test the effectiveness of an inpatient peer recovery coaching service called the RC-Link program on recovery outcomes in patients hospitalized with medical complications from AUD. The program involves a bedside introduction to a peer recovery coach during the patient's hospitalization plus continued, recovery support for six-months. The RC-Link program provides standardized peer recovery service that is both personalized to the patients' needs and generalized to provide socioemotional, instrumental, and informational social support during every patient encounter. Aim 1 will determine the effect of the RC-Link program on frequency of heavy drinking, biopsychosocial functioning, and remission from AUD compared to controls. Aim 2 will examine how daily changes in perceived social support and self-efficacy influence alcohol consumption and determine whether such associations differ between the RC-Link and control groups. Aim 3 will examine the cost-effectiveness of the RC-Link program; hospital utilization rates will be examined as secondary outcomes. These aims will be evaluated using a two-arm randomized controlled trial that compares the RC-Link program intervention to a control group that receives a brief intervention and connection to a peer recovery coach after the study period. Outcomes will be assessed at baseline, monthly during the 6-month study period, and 6-months post- intervention. This study has potential to advance recovery care for AUD by providing a better understanding of how long-term, inpatient-initiated peer recovery coaching influences recovery outcomes over time in this population.
- Conditions
- Alcohol Use Disorder
- Being tested
- Peer recovery coaching (PRC), Brief Intervention (SBIRT)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer recovery coaching (PRC)Behavioural
The RC-Link peer recovery coaching intervention provides participants with an introduction to an RC-Link coach during their hospitalization. The RC-Link coach delivers coaching and support services for a 6-month period using a standardized PRC Checklist. During the baseline visit, the RC-Link coach first develops a personalized recovery plan with the participant that emphasizes multiple pathways to recovery, including different types of mutual aid groups, counseling, and alternative recovery tools. The approach empowers the participant with an actionable recovery plan that can be initiated upon discharge, but the plan can be modified as changes arise. After the initial baseline encounter, the RC-Link coach initiates phone, virtual, and/or in-person contact with the participant a minimum of twice weekly using the PRC Checklist to standardize service delivery.
Brief Intervention (SBIRT)Behavioural
The control will receive a brief intervention, usual care (a referral list), contact information for the study team and hospital case management, and a follow-up contact at the end of the study period. The brief intervention entails (a) using motivational interviewing to gauge the individual's perspective of drinking, how it influences their life, and readiness for change; (b) provide information about the risks of hazardous drinking and potential ways to reduce drinking; (c) elicit their feedback; listen to their concerns; offer encouragement; encourage them to establish goals for behavior change; and (d) provide resources for change (e.g., the referral list). The referral list includes contact information for no-cost peer recovery coach through FAVOR that the participant could choose to call via self-referral. Thus, control participants are able to be linked to PRC, but they must initiate the call and initial visit outside the hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| Long-term peer recovery coaching intervention | Experimental | bedside peer recovery coaching + 6-months long-term engagement Receives: Behavioral: Peer recovery coaching (PRC) |
| SBIRT Intervention | Active comparator | The control will receive a brief intervention, usual care (a referral list), contact information for the study team and hospital case management, and a follow-up contact at the end of the study period. Receives: Behavioral: Brief Intervention (SBIRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage of Heavy Drinking Days Per Month
This outcome will be measured using the Alcohol Timeline Follow Back (TLFB), a calendar-based, self-report survey. The TLFB is the most widely used measure of alcohol use frequency in treatment trials for AUD and has strong reliability and validity in diverse populations.
Measured: one-month, 3-months, 6-months
Remission from Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) AUD Diagnosis
The DSM-5 checklist for AUD will be used to assess AUD diagnosis. Remission is defined as meeting 0 of the 11 criteria for AUD diagnosis, excluding craving. According to the NIAAA recovery definition, cessation of heavy drinking and AUD remission are classified as the following durations: initial (0-3 months), early (3-12 months), sustained (1-5 years), and stable (>5 years). Using this definition, primary study endpoints will be 1-month post-baseline (initial recovery; past 1 month symptoms), 3-month post-baseline (early recovery; past 3-month symptoms), 6-month post-baseline (end of intervention period), and 1-year post-baseline (sustained recovery; past 12-month symptoms)
Measured: one-month, 3-months, 6-months, 12-months
Change in Biopsychosocial Functioning
The self-report World Health Organization (WHO) Quality of Life brief version (WHOQoL-BREF) will measure biopsychosocial functioning. There are subscales for physical functioning, psychological functioning, level of independence, social relationships, environment, and spirituality. Items are scored on a 1 - 5 scale with higher scores reflecting higher levels of that subscale domain. These items are them transformed so that the raw scale score for each domain is converted to a 0-100 scale with higher scores reflecting greater quality of life on that domain.
Measured: one-month, 3-months, 6-months
Cost Effectiveness
The intervention cost will be determined by gauging recovery coach salaries and additional medical provider and support staff time required, and applying this cost to each interaction. We will examine the cost of hospital services (hospital charges), including emergency department visits, hospitalizations, psychiatric inpatient stay, medical outpatient costs, and physician professional fee costs.
Measured: 6-months
Secondary outcomes (7)
Change in Coping
The self-reported Brief Coping Orientation to Problems Experienced (COPE) Inventory 28-item scale will be used and administered. Items on this scale range from 1 (I haven't been doing this at all) to 4 (I have been doing this a lot). There are two items for 14 coping strategies, such as self-distraction, emotional support, humor, self-blame, and denial. Higher scores reflect a higher degree of engaging in a particular coping strategies.
Measured: one-month, 3-months, 6-months, 12-months
Change in linkage to and engagement in Evidence-Based Practices
Percentage of participants linked and percentage of participants engaged: Participants will indicate the types of evidence-based practices (EBPs) for AUD that they have been engaged in and the number of days they engaged in EBPs in the past month. EBPs for AUD are defined by the NIAAA as FDA-approved pharmacology for AUD (disulfiram, acamprosate \& naltrexone), inpatient/outpatient rehabilitation, therapy/counseling, and mutual aid programs (e.g., 12-step programs, SMART recovery, etc.).
Measured: one-month, 3-months, 6-months, 12-months
Change in linkage to and engagement in Social Determinants of Health (SDoH) resources
Percentage of participants linked and percentage of participants utilizing resources: Participants will be asked if anyone (family/friend, recovery coach, social worker, etc.) helped provide them with housing, employment, education, food security, or transportation assistance in the past month, and if so, what services and who helped them.
Measured: one-month, 3-months, 6-months, 12-months
Hospital Utilization
Hospital utilization refers to the number of overall and alcohol-specific inpatient admission and emergency visits.
Measured: 6-months
EMA: Heavy Drinking
Two-items from the Daily Drinking Questionnaire will be used: one queries whether participants drank alcohol that day (yes/no) and the other assesses amount consumed
Measured: 6-months
EMA: Breath Alcohol Content (BrAC) Levels
Breath alcohol content levels will be measured using a breathalyzer (BACtrack) as an objective measure of alcohol consumption, which controls for the possibility that differences in self-reported consumption are due to inaccurate reporting.
Measured: 6-months
EMA: Change in Craving
This will be measured using a single-item questionnaire administered via EMA
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start25 Apr 2024
- Primary completion1 Feb 2028 (estimated)
- Study completion2 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clemson University
- Sponsor type
- University, hospital or other
- Collaborators
- Prisma Health-Upstate, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479681
- Sponsor's protocol ID
- 2089000(Prisma),2024-0110(CU)
- Other IDs
- 1R01AA030815
- Acronym
- RC-Link
- Status last verified
- Aug 2025
- First submitted
- 24 Jun 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Peer Recovery Coaching Intervention for Hospitalized Alcohol Use Disorder Patients
- ClinicalTrials.gov ID
- NCT06479681
- Acronym / sponsor ID
- RC-Link / 2089000(Prisma),2024-0110(CU)
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Clemson UniversityUniversity, hospital or other
- Collaborators
- Prisma Health-Upstate, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 2 Jun 2028 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project objective is to rigorously evaluate the effectiveness of a peer recovery coaching intervention (called RC-Link) in patients hospitalized with medical complications from alcohol use on recovery outcomes guided by the new NIAAA definition of recovery, examine mechanisms of heavy drinking using daily ecological momentary assessment (EMA), and determine the program's cost-effectiveness using an randomized controlled trial (RCT) design. The primary outcomes are frequency of heavy drinking, biopsychosocial functioning, and remission from AUD.
Detailed description
Alcohol Use Disorder (AUD) is the third leading cause of preventable deaths in U.S. and accounts for over 10% of U.S. hospital admissions. Treatment for this population often fails to address the underlying cause of the hospitalization: the AUD. Patients hospitalized with alcohol-related medical complications tend to have high-risk for recurrence of alcohol-related medical problems, high rates of hospital readmissions, and poor recovery outcomes. Methods that promote long-term recovery care are needed. Inpatient linkage to peer recovery coaching may bridge this gap in care by providing a method of continued care for AUD recovery that offers flexibility in recovery pathways, peer modeling opportunities, and strong social support. Pilot study results demonstrated the feasibility of inpatient linkage to peer recovery coaching and showed evidence of decreased alcohol consumption, increased engagement in treatment and recovery support programs, and decreased emergency department visits. However, pilot study sample size, outcomes, and methods were limited. This proposal seeks to overcome these limitations and build on these preliminary results by: using ecological momentary assessments, measuring recovery using the new NIAAA definition, examining cost-effectiveness, assessing alcohol consumption using an additional objective measure (breath alcohol content levels), and examining social support and self-efficacy as potential mechanisms of effectiveness. This proposal will rigorously test the effectiveness of an inpatient peer recovery coaching service called the RC-Link program on recovery outcomes in patients hospitalized with medical complications from AUD. The program involves a bedside introduction to a peer recovery coach during the patient's hospitalization plus continued, recovery support for six-months. The RC-Link program provides standardized peer recovery service that is both personalized to the patients' needs and generalized to provide socioemotional, instrumental, and informational social support during every patient encounter. Aim 1 will determine the effect of the RC-Link program on frequency of heavy drinking, biopsychosocial functioning, and remission from AUD compared to controls. Aim 2 will examine how daily changes in perceived social support and self-efficacy influence alcohol consumption and determine whether such associations differ between the RC-Link and control groups. Aim 3 will examine the cost-effectiveness of the RC-Link program; hospital utilization rates will be examined as secondary outcomes. These aims will be evaluated using a two-arm randomized controlled trial that compares the RC-Link program intervention to a control group that receives a brief intervention and connection to a peer recovery coach after the study period. Outcomes will be assessed at baseline, monthly during the 6-month study period, and 6-months post- intervention. This study has potential to advance recovery care for AUD by providing a better understanding of how long-term, inpatient-initiated peer recovery coaching influences recovery outcomes over time in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-term peer recovery coaching intervention | Experimental | Behavioral: Peer recovery coaching (PRC)bedside peer recovery coaching + 6-months long-term engagement |
| SBIRT Intervention | Active comparator | Behavioral: Brief Intervention (SBIRT)The control will receive a brief intervention, usual care (a referral list), contact information for the study team and hospital case management, and a follow-up contact at the end of the study period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Live within 50 miles of the recruitment and plan to stay in the area for at least 6 months
- Current DSM-V criteria for moderate or severe AUD (measured by a score of ≥4 on the DSM-V Checklist)
- Hospitalized with a principal, primary, or secondary AUD-related diagnosis
Key exclusion criteria (10 listed)
- Unable to provide informed consent
- Patients referred to hospice during hospitalization
- Women who are pregnant
- Comorbid diagnosis or at-risk for methamphetamine, cocaine, or opioid use disorder as determined by a score of ≥4 on the National Institute on Drug Abuse (NIDA) Modified Assist v3.0
- Current suicidal ideation
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 recovery coaching (PRC)The RC-Link peer recovery coaching intervention provides participants with an introduction to an RC-Link coach during their hospitalization. The RC-Link coach delivers coaching and support services for a 6-month period using a standardized PRC Checklist. During the baseline visit, the RC-Link coach first develops a personalized recovery plan with the participant that emphasizes multiple pathways to recovery, including different types of mutual aid groups, counseling, and alternative recovery tools. The approach empowers the participant with an actionable recovery plan that can be initiated upon discharge, but the plan can be modified as changes arise. After the initial baseline encounter, the RC-Link coach initiates phone, virtual, and/or in-person contact with the participant a minimum of twice weekly using the PRC Checklist to standardize service delivery. | Behavioural | Long-term peer recovery coaching intervention |
| Brief Intervention (SBIRT)The control will receive a brief intervention, usual care (a referral list), contact information for the study team and hospital case management, and a follow-up contact at the end of the study period. The brief intervention entails (a) using motivational interviewing to gauge the individual's perspective of drinking, how it influences their life, and readiness for change; (b) provide information about the risks of hazardous drinking and potential ways to reduce drinking; (c) elicit their feedback; listen to their concerns; offer encouragement; encourage them to establish goals for behavior change; and (d) provide resources for change (e.g., the referral list). The referral list includes contact information for no-cost peer recovery coach through FAVOR that the participant could choose to call via self-referral. Thus, control participants are able to be linked to PRC, but they must initiate the call and initial visit outside the hospital setting. | Behavioural | SBIRT Intervention |
Primary outcome
Change in Percentage of Heavy Drinking Days Per Month
Time frame: one-month, 3-months, 6-months
This outcome will be measured using the Alcohol Timeline Follow Back (TLFB), a calendar-based, self-report survey. The TLFB is the most widely used measure of alcohol use frequency in treatment trials for AUD and has strong reliability and validity in diverse populations.
Remission from Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) AUD Diagnosis
Time frame: one-month, 3-months, 6-months, 12-months
The DSM-5 checklist for AUD will be used to assess AUD diagnosis. Remission is defined as meeting 0 of the 11 criteria for AUD diagnosis, excluding craving. According to the NIAAA recovery definition, cessation of heavy drinking and AUD remission are classified as the following durations: initial (0-3 months), early (3-12 months), sustained (1-5 years), and stable (>5 years). Using this definition, primary study endpoints will be 1-month post-baseline (initial recovery; past 1 month symptoms), 3-month post-baseline (early recovery; past 3-month symptoms), 6-month post-baseline (end of intervention period), and 1-year post-baseline (sustained recovery; past 12-month symptoms)
Change in Biopsychosocial Functioning
Time frame: one-month, 3-months, 6-months
The self-report World Health Organization (WHO) Quality of Life brief version (WHOQoL-BREF) will measure biopsychosocial functioning. There are subscales for physical functioning, psychological functioning, level of independence, social relationships, environment, and spirituality. Items are scored on a 1 - 5 scale with higher scores reflecting higher levels of that subscale domain. These items are them transformed so that the raw scale score for each domain is converted to a 0-100 scale with higher scores reflecting greater quality of life on that domain.
Cost Effectiveness
Time frame: 6-months
The intervention cost will be determined by gauging recovery coach salaries and additional medical provider and support staff time required, and applying this cost to each interaction. We will examine the cost of hospital services (hospital charges), including emergency department visits, hospitalizations, psychiatric inpatient stay, medical outpatient costs, and physician professional fee costs.
7 secondary outcomes
Change in Coping
Time frame: one-month, 3-months, 6-months, 12-months
Change in linkage to and engagement in Evidence-Based Practices
Time frame: one-month, 3-months, 6-months, 12-months
Change in linkage to and engagement in Social Determinants of Health (SDoH) resources
Time frame: one-month, 3-months, 6-months, 12-months
Hospital Utilization
Time frame: 6-months
EMA: Heavy Drinking
Time frame: 6-months
EMA: Breath Alcohol Content (BrAC) Levels
Time frame: 6-months
EMA: Change in Craving
Time frame: 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer recovery coaching (PRC) and Brief Intervention (SBIRT) in people with Alcohol Use Disorder, run by Clemson University at 2 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 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 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 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaileigh Byrne, PhD (864-656-3935, kaileib@clemson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percentage of Heavy Drinking Days Per Month (time frame: one-month, 3-months, 6-months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.