Unhealthy Alcohol UseFIRSTNCT03089320
Financial Incentives, Randomization With Stepped Treatment Trial
A study testing Contingency Management Counseling, Addiction Physician Management and Motivational Enhancement Therapy in people with Unhealthy Alcohol Use, run by Yale University at 7 sites in United States.
Trial summary
The investigators plan to determine the effectiveness of contingency management (CM) plus stepped care for unhealthy alcohol use in HIV-positive patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unhealthy Alcohol Use
- What is being tested?
- Contingency Management Counseling, Addiction Physician Management and Motivational Enhancement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 May 2018to 1 Apr 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be HIV-infected.
- Recent significant alcohol consumption as determined by a PEth greater than 20 ng/ml.
- Able to provide informed consent.
- Meet any of the following criteria for unhealthy alcohol use:
- At-risk Drinking - greater than 14 drinks per week or greater than 4 drinks per occasion in men and greater than 7 drinks per week or greater than 3 drinks per occasion in women and those over 65.161
- Medical condition impacted by alcohol as evidenced by one of the following: 1) detectable HIV viral load (>200 copies/ml),) tobacco use disorder and smoking more than 5 cigarettes per day, 3) detectable HCV virus, 4) liver fibrosis with a FIB-4 >1.45) Patient Health Questionnaire (PHQ-9, validated measure for depression) score greater than 9, or 6) current (at least 30 day supply in the past 60 days) prescription for a psychoactive medication that interacts with alcohol-including benzodiazepines, opioids, antipsychotics, antidepressants, sleeping medications and muscle relaxants.
- Alcohol Use Disorder - Meet DSM-5 criteria for alcohol use disorder, not in remission
Who cannot join
- No subject may:
- Be acutely suicidal, or with a psychiatric condition that affects his/her ability to provide informed consent or participate in counseling interventions (e.g. psychotic, dementia, delusional).
- Be currently enrolled in formal treatment for alcohol (excluding mutual-help, e.g. Alcoholics Anonymous)
- Have medical conditions that would preclude completing or be of harm during the course of the study.
- Be a pregnant or nursing woman or women who do not agree to use a reliable form of birth control.
- Have a current diagnosis of or be in remission for a gambling disorder given the gaming nature of CM.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
VA Medical Center
Atlanta, Georgia, 30033
VAMC Houston
Houston, Texas, 77030
Greater Los Angeles VA Healthcare Center Infectious Disease Section
Los Angeles, California, 90073
Louisiana Health Sciences Center
New Orleans, Louisiana, 70112
VA NY Harbor Healthcare System
New York, New York, 10010
James J. Peters VA Medical Center
The Bronx, New York, 10468
Washington DC Veterans Affairs
Washington D.C., District of Columbia, 20422
About this study
The investigators plan to determine the effectiveness of contingency management (CM) plus stepped care for unhealthy alcohol use in HIV-positive patients.
Read the detailed description
HIV-positive patients with unhealthy alcohol use are not often motivated to decrease their alcohol consumption and rarely receive treatment for their drinking. To address these challenges, we plan to provide treatment in HIV clinics, highlight to patients the impact alcohol can have on their medical conditions, and use Contingency Management (CM) with a stepped care design to adjust treatment to patient response. CM is an evidence based therapy that promotes abstinence from substance use, including alcohol. Since CM has not been studied for unhealthy alcohol use in HIV-infected patients we will include a stepped care strategy that provides Addiction Psychiatrist Management (APM) (with alcohol pharmacotherapies as indicated) and Motivational Enhancement Therapy (MET) for patients who do not achieve abstinence with CM. Phosphatidylethanol (PEth), is a validated biomarker that can confirm alcohol abstinence over three weeks. To capture the range of adverse effects of alcohol on health, we will include patients with at-risk drinking, alcohol use disorder, and medical conditions that can be adversely impacted by alcohol including those with a detectable HIV viral load, tobacco use disorder, liver fibrosis, untreated hepatitis C, depression and those taking psychoactive medications that interact with alcohol. The goal of the Financial Incentives, Randomization with Stepped Treatment (FIRST) Trial is to compare onsite CM plus stepped care versus treatment as usual (TAU) in a randomized clinical trial of HIV-positive patients with unhealthy alcohol use at seven HIV clinics. CM patients will receive onsite CM counseling sessions with financial rewards contingent on abstinence demonstrated by breathalyzer and PEth. Rewards can also be awarded for addressing medical conditions impacted by alcohol and achieving alcohol treatment goals. After three months, patients will be stepped up to APM and MET if PEth results indicate they have not attained abstinence. This randomized clinical trial will test the hypothesis that CM plus stepped care leads to greater abstinence, decreased alcohol consumption and improved HIV biomarkers as measured by the VACS Index.
In addition to the randomized control trial, the FIRST Trial Implementation sub-study will be launched in the final year of the study. The goals of this sub-study are to explore barriers and facilitators to implementation of contingency management to address unhealthy alcohol in HIV treatment settings as it relates to: a) adoption, b) feasibility, c) acceptability, and d) tools and training needs to promote high fidelity implementation. In the context of the FIRST trial, we seek to recruit patient participants and the staff (i.e., research coordinators and Social Workers) involved with delivering CM across participating sites. Patient participants will be enrolled from the three highest-enrolling sites to complete an in-depth telephone interview. Staff participants from all sites involved in implementing study protocols will be invited to participate in a brief online survey and a focus group. Qualitative data will be analyzed by a multidisciplinary team using content analysis to identify themes and ideas regarding barrier and facilitators to CM implementation.
- Conditions
- Unhealthy Alcohol Use
- Being tested
- Contingency Management Counseling, Addiction Physician Management, Motivational Enhancement Therapy
- Keywords
- HIV, Heavy drinking, Alcohol Abuse, AIDS
- Medical subject headings
- Alcoholism, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency Management CounselingBehavioural
Contingency management (CM) is an efficacious treatment for individuals with substance use disorders. In line with operant conditioning, CM typically provides reinforcers (rewards) contingent upon attaining specified goals such as decreased substance use and/or abstinence.
Addiction Physician ManagementBehavioural
Patients in the CM plus stepped care arm who have PEth > 8 ng/ml at 3 months will progress to Step 2 and receive onsite treatment from an Addiction Psychiatrist (APM) in the HIV clinic. APM will provide care that is typically provided by physicians in specialty referral programs.
Motivational Enhancement TherapyBehavioural
Patients in the CM plus stepped care arm who have PEth > 8 ng/ml at 3 months will progress to Step 2 and receive onsite Motivational Enhancement Therapy (MET) from the Social Worker in the HIV clinic.
MET is grounded in research on processes of natural recovery during which patients move through stages of change - precontemplation, contemplation, determination, action, and maintenance. The Social Worker's role is to assist the patient in moving through the stages of change. MET uses motivational interviewing and reflective listening to help patients identify internal sources of motivation to support reductions in alcohol.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual (TAU) | No intervention | We have elected to compare the CM plus stepped care condition to TAU to test its efficacy against a "real world" control and because CM plus stepped care is a comprehensive stand alone intervention that would substitute for TAU. While annual AUDIT-C screening is mandatory at the 7 sites, providing interventions for patients with unhealthy alcohol use is a matter of physician judgment and individual clinical practice with wide practice variation. HIV clinicians will not receive knowledge of the results of follow-up research assessments. We will conduct a Treatment Services Review at each follow-up to assess for receipt of addiction treatment services received since the last assessment and assess for contamination. |
| Contingency Management plus Stepped Care (Step 2) | Experimental | Step 1: Contingency management; Step 2: Addiction physician management and motivational enhancement therapy
Consistent with tenets of stepped care designs we provide a priori intervals and criteria (drinking targets) that dictate increasing the intensity of treatment (stepping up) based on research and standards in the field. All CM plus stepped care subjects will undergo PEth testing at 3 months to determine the efficacy of Step 1. Patients with a PEth > 8 ng/ml will continue on to Step 2. Receives: Behavioral: Contingency Management Counseling; Behavioral: Addiction Physician Management; Behavioral: Motivational Enhancement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Abstinence From Alcohol
Recorded via web based time-line followback
Measured: 6 months
Secondary outcomes (2)
Proportion of Participants of Participants With Phosphatidylethanol (PeTH) Documented Abstinence by the Alcohol Biomarker, Phosphatidylethanol (PEth)
Phosphatidylethanol (PEth) accumulates in human red blood cells when the body is exposed to ethanol. Alcohol biomarkers are physiological indicators of alcohol exposure or ingestion and may reflect the presence of chronic and/or high level of use of alcohol. This will be evaluated as a binary variable to determine the proportion with abstinence (defined as % with PEth value <8ng/mL).
Measured: 6 month
Change in Biological Markers as Measured by the VACS Index
The Veterans Aging Cohort Study Index (VACS Index) creates a score by summing pre-assigned points for age, routinely monitored indicators of HIV disease (CD4 count and HIV-1 RNA), and general indicators of organ system injury including hemoglobin, platelets, aspartate and alanine transaminase (AST and ALT), creatinine, and viral hepatitis C infection (HCV). This score is weighted to indicate increasing risk of all-cause mortality with increasing score. The score can be used to estimate risk of all-cause mortality using a conversion factor. The VACS Index will be evaluated based on most recent values at the time of data extraction. VACS Index score will be treated as a continuous variable. Possible scores range from 0 to 164. A higher score indicates greater burden of disease.
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 posted24 Mar 2017
- Study start1 May 2018
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
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 (2)Papers the sponsor has linked to this study.
- Other trials for Unhealthy Alcohol UseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Connecticut Healthcare System, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- David Fiellin, MD, Principal investigator, Yale UniversityE. Jennifer Edelman, MD, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089320
- Sponsor's protocol ID
- 2000020383
- Other IDs
- U01AA020795
- Acronym
- FIRST
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2017
- Last updated
- 15 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edelman EJ, Dziura J, Deng Y, DePhilippis D, Ferguson T, Brown S, Marconi VC, Goetz MB, Rodriguez-Barradas MC, Simberkoff MS, Molina PE, Weintrob AC, Maisto SA, Paris M, Justice AC, Bryant KJ, Fiellin DA. Integrated Stepped Alcohol Treatment With Contingency Management for Unhealthy Alcohol Use Among People With HIV: A Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2025 Jan 1;98(1):72-81. doi: 10.1097/QAI.0000000000003534.
PubMed 39321757Edelman EJ, Dziura J, Deng Y, DePhilippis D, Fucito LM, Ferguson T, Bedimo R, Brown S, Marconi VC, Goetz MB, Rodriguez-Barradas MC, Simberkoff MS, Molina PE, Weintrob AC, Maisto SA, Paris M, Justice AC, Bryant KJ, Fiellin DA. Contingency management with stepped care for unhealthy alcohol use among individuals with HIV: Protocol for a randomized controlled trial. Contemp Clin Trials. 2023 Aug;131:107242. doi: 10.1016/j.cct.2023.107242. Epub 2023 May 23.
PubMed 37230168
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentives, Randomization With Stepped Treatment Trial
- ClinicalTrials.gov ID
- NCT03089320
- Acronym / sponsor ID
- FIRST / 2000020383
- Conditions
- Unhealthy Alcohol Use
- Keywords
- HIV, Heavy drinking, Alcohol Abuse, AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- VA Connecticut Healthcare System, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Posted 15 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to determine the effectiveness of contingency management (CM) plus stepped care for unhealthy alcohol use in HIV-positive patients.
Detailed description
HIV-positive patients with unhealthy alcohol use are not often motivated to decrease their alcohol consumption and rarely receive treatment for their drinking. To address these challenges, we plan to provide treatment in HIV clinics, highlight to patients the impact alcohol can have on their medical conditions, and use Contingency Management (CM) with a stepped care design to adjust treatment to patient response. CM is an evidence based therapy that promotes abstinence from substance use, including alcohol. Since CM has not been studied for unhealthy alcohol use in HIV-infected patients we will include a stepped care strategy that provides Addiction Psychiatrist Management (APM) (with alcohol pharmacotherapies as indicated) and Motivational Enhancement Therapy (MET) for patients who do not achieve abstinence with CM. Phosphatidylethanol (PEth), is a validated biomarker that can confirm alcohol abstinence over three weeks. To capture the range of adverse effects of alcohol on health, we will include patients with at-risk drinking, alcohol use disorder, and medical conditions that can be adversely impacted by alcohol including those with a detectable HIV viral load, tobacco use disorder, liver fibrosis, untreated hepatitis C, depression and those taking psychoactive medications that interact with alcohol. The goal of the Financial Incentives, Randomization with Stepped Treatment (FIRST) Trial is to compare onsite CM plus stepped care versus treatment as usual (TAU) in a randomized clinical trial of HIV-positive patients with unhealthy alcohol use at seven HIV clinics. CM patients will receive onsite CM counseling sessions with financial rewards contingent on abstinence demonstrated by breathalyzer and PEth. Rewards can also be awarded for addressing medical conditions impacted by alcohol and achieving alcohol treatment goals. After three months, patients will be stepped up to APM and MET if PEth results indicate they have not attained abstinence. This randomized clinical trial will test the hypothesis that CM plus stepped care leads to greater abstinence, decreased alcohol consumption and improved HIV biomarkers as measured by the VACS Index.
In addition to the randomized control trial, the FIRST Trial Implementation sub-study will be launched in the final year of the study. The goals of this sub-study are to explore barriers and facilitators to implementation of contingency management to address unhealthy alcohol in HIV treatment settings as it relates to: a) adoption, b) feasibility, c) acceptability, and d) tools and training needs to promote high fidelity implementation. In the context of the FIRST trial, we seek to recruit patient participants and the staff (i.e., research coordinators and Social Workers) involved with delivering CM across participating sites. Patient participants will be enrolled from the three highest-enrolling sites to complete an in-depth telephone interview. Staff participants from all sites involved in implementing study protocols will be invited to participate in a brief online survey and a focus group. Qualitative data will be analyzed by a multidisciplinary team using content analysis to identify themes and ideas regarding barrier and facilitators to CM implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU) | No intervention | –We have elected to compare the CM plus stepped care condition to TAU to test its efficacy against a "real world" control and because CM plus stepped care is a comprehensive stand alone intervention that would substitute for TAU. While annual AUDIT-C screening is mandatory at the 7 sites, providing interventions for patients with unhealthy alcohol use is a matter of physician judgment and individual clinical practice with wide practice variation. HIV clinicians will not receive knowledge of the results of follow-up research assessments. We will conduct a Treatment Services Review at each follow-up to assess for receipt of addiction treatment services received since the last assessment and assess for contamination. |
| Contingency Management plus Stepped Care (Step 2) | Experimental | Behavioral: Contingency Management Counseling, Behavioral: Addiction Physician Management, Behavioral: Motivational Enhancement TherapyStep 1: Contingency management; Step 2: Addiction physician management and motivational enhancement therapy Consistent with tenets of stepped care designs we provide a priori intervals and criteria (drinking targets) that dictate increasing the intensity of treatment (stepping up) based on research and standards in the field. All CM plus stepped care subjects will undergo PEth testing at 3 months to determine the efficacy of Step 1. Patients with a PEth > 8 ng/ml will continue on to Step 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be HIV-infected.
- Recent significant alcohol consumption as determined by a PEth greater than 20 ng/ml.
- Able to provide informed consent.
- Meet any of the following criteria for unhealthy alcohol use:
- At-risk Drinking - greater than 14 drinks per week or greater than 4 drinks per occasion in men and greater than 7 drinks per week or greater than 3 drinks per occasion in women and those over 65.161
Key exclusion criteria (6 listed)
- Be acutely suicidal, or with a psychiatric condition that affects his/her ability to provide informed consent or participate in counseling interventions (e.g. psychotic, dementia, delusional).
- Be currently enrolled in formal treatment for alcohol (excluding mutual-help, e.g. Alcoholics Anonymous)
- Have medical conditions that would preclude completing or be of harm during the course of the study.
- Be a pregnant or nursing woman or women who do not agree to use a reliable form of birth control.
- Have a current diagnosis of or be in remission for a gambling disorder given the gaming nature of CM.
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 |
|---|---|---|
| Contingency Management CounselingContingency management (CM) is an efficacious treatment for individuals with substance use disorders. In line with operant conditioning, CM typically provides reinforcers (rewards) contingent upon attaining specified goals such as decreased substance use and/or abstinence. | Behavioural | Contingency Management plus Stepped Care (Step 2) |
| Addiction Physician ManagementPatients in the CM plus stepped care arm who have PEth > 8 ng/ml at 3 months will progress to Step 2 and receive onsite treatment from an Addiction Psychiatrist (APM) in the HIV clinic. APM will provide care that is typically provided by physicians in specialty referral programs. | Behavioural | Contingency Management plus Stepped Care (Step 2) |
| Motivational Enhancement TherapyPatients in the CM plus stepped care arm who have PEth > 8 ng/ml at 3 months will progress to Step 2 and receive onsite Motivational Enhancement Therapy (MET) from the Social Worker in the HIV clinic. MET is grounded in research on processes of natural recovery during which patients move through stages of change - precontemplation, contemplation, determination, action, and maintenance. The Social Worker's role is to assist the patient in moving through the stages of change. MET uses motivational interviewing and reflective listening to help patients identify internal sources of motivation to support reductions in alcohol. | Behavioural | Contingency Management plus Stepped Care (Step 2) |
Primary outcome
Self-reported Abstinence From Alcohol
Time frame: 6 months
Recorded via web based time-line followback
2 secondary outcomes
Proportion of Participants of Participants With Phosphatidylethanol (PeTH) Documented Abstinence by the Alcohol Biomarker, Phosphatidylethanol (PEth)
Time frame: 6 month
Change in Biological Markers as Measured by the VACS Index
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39321757Edelman EJ, Dziura J, Deng Y, DePhilippis D, Ferguson T, Brown S, Marconi VC, Goetz MB, Rodriguez-Barradas MC, Simberkoff MS, Molina PE, Weintrob AC, Maisto SA, Paris M, Justice AC, Bryant KJ, Fiellin DA. Integrated Stepped Alcohol Treatment With Contingency Management for Unhealthy Alcohol Use Among People With HIV: A Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2025 Jan 1;98(1):72-81. doi: 10.1097/QAI.0000000000003534.
- Derived from this study: PubMed 37230168Edelman EJ, Dziura J, Deng Y, DePhilippis D, Fucito LM, Ferguson T, Bedimo R, Brown S, Marconi VC, Goetz MB, Rodriguez-Barradas MC, Simberkoff MS, Molina PE, Weintrob AC, Maisto SA, Paris M, Justice AC, Bryant KJ, Fiellin DA. Contingency management with stepped care for unhealthy alcohol use among individuals with HIV: Protocol for a randomized controlled trial. Contemp Clin Trials. 2023 Aug;131:107242. doi: 10.1016/j.cct.2023.107242. Epub 2023 May 23.
- 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.
David Fiellin, MD principal investigator
Yale University
E. Jennifer Edelman, MD study director
Yale University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management Counseling, Addiction Physician Management and Motivational Enhancement Therapy in people with Unhealthy Alcohol Use, run by Yale University at 7 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 7 inclusion and 6 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 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 15 Apr 2024). 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?
Self-reported Abstinence From Alcohol (time frame: 6 months). 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 NCT03089320, which also lists 2 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 15 Apr 2024; AzTrials last refreshed its copy on 29 Oct 2026.