FearNCT02438969
Epi-Genetic Modulators of Fear Extinction in Alcohol Dependence
An observational study of Fear and Stress, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
Background: Researchers want to learn if people with alcohol dependence have more difficulty learning to feel calm, or learn to fear things more easily. They also want to study how early life stress (ELS) affects the ability to learn to feel calm. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear, Stress, Alcohol Dependence
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2015to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: AUD participants will be recruited from participants in the NIAAA screening platform protocols 14-AA-0181. Non-AUD participants will be recruited from participants in the NIAAA protocol 14-AA-0181. We will recruit all racial and ethnic groups in the greater Washington DC area
Who may be able to join
- Inclusion and exclusion criteria will be evaluated following screening conducted under the NIAAA screening protocols (98-AA-009 and/or 14-AA-0181).
- Between 21 and 65 years of age
- Ability to provide written informed consent as determined by successful completion of consent quiz prior to signing consent
- Females: Negative urine pregnancy test, not currently breastfeeding, agree to abstain or use accepted form of contraception
- Diagnosed with current alcohol dependence according to Diagnostic and Statistical Manual for Mental Disorders-Fourth Edition (DSM IV)
- Alcohol consumption within the past month provided by self-report
Show all 15Show fewer
- Specify alcohol as their preferred drug in a clinical interview
- 98-AA-0009 and/or 14-AA-0181 screening consents signed
- Cleared venous access assessment
- Additional inclusion criteria for non-treatment seeking AUD: Able and willing to abstain from consuming alcohol 1 day prior to each study visit
- Between 21 and 65 years of age
- Ability to provide written informed consent as determined by successful completion of consent quiz prior to signing consent
- Females: Negative urine pregnancy test, not currently breastfeeding, agree to abstain or use accepted form of contraception
- 98-AA-0009 and/or 14-AA-0181 screening consents signed
- Cleared venous access assessment
Who cannot join
- Neurological symptoms of the wrist or arm, e.g., carpal tunnel syndrome, as determined by history and physical exam
- Chronic use of psychotropic medications within four weeks of the study, with the exception of fluoxetine, for which the exclusionary time period is six weeks. Incidental use of psychotropic medications is allowed, but any use must be discontinued prior to the study for a time period exceeding 5 half-lives of the medication in question.
- Presence of any current or past DSM IV diagnosis of bipolar disorder, or psychotic disorder (e.g, schizophrenia, schizoaffective disorder), or current substance dependence other than alcohol, nicotine, or caffeine.
- Major medical problems (e.g., central nervous system (CNS), cardiovascular, respiratory, gastrointestinal (GI), hepatic, renal, endocrine, HIV, reproductive) that in the judgment of the PI, in consultation with relevant Clinical Center consult services, cannot be adequately managed at the Clinical Center.
- Presence of ferromagnetic objects in the body, fear of enclosed spaces, or other standard contraindication to MRI, as determined by self-report
- Left-handedness
Show all 26Show fewer
- Use of intrauterine device (IUD)
- Excluded from the optional DEX-CRH test if:
- Allergy to dexamethasone or CRH
- Use of medications that can affect the results of the test, including certain antibiotics, anti-seizure drugs, corticosteroids, and hormonal contraception
- Additional exclusionary criteria for non-treatment seeking AUD:
- Presence of significant alcohol withdrawal symptoms, defined as a CIWA-Ar > 8.
- History of epilepsy or alcohol-related seizures.
- Are currently seeking treatment for alcohol problems
- Neurological symptoms of the wrist or arm, e.g., carpal tunnel syndrome, as determined by history and physical exam.
- Chronic use of psychotropic medications within four weeks of the study, with the exception of fluoxetine, for which the exclusionary time period is six weeks. Incidental use of psychotropic medications is allowed, but any use must be discontinued prior to the study for a time period exceeding 5 half-lives of the medication in question.
- Presence of any current or past DSM IV diagnosis of bipolar disorder, or psychotic disorder (e.g, schizophrenia, schizoaffective disorder), or substance dependence other than nicotine, or caffeine.
- Major medical problems (e.g., CNS, cardiovascular, respiratory, GI, hepatic, renal, endocrine, HIV, reproductive) that in the judgment of the PI, in consultation with relevant Clinical Center consult services, cannot be adequately managed at the Clinical Center
- Presence of ferromagnetic objects in the body, fear of enclosed spaces, or other standard contraindication to MRI, as determined by self-report
- Current or past DSM IV diagnosis of alcohol dependence or abuse
- Currently seeking treatment for alcohol problems as assessed by self-report
- Positive urine drug test at screening (for opiates, cannabinoids, amphetamines, cocaine, benzodiazepines)
- Positive breathalyzer test at screening
- Alcohol abstainer (never consumed alcohol in entire life)
- Left-handedness
- Use of intrauterine device (IUD)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: (Epi)Genetic Modulators of Fear Extinction in Alcohol Dependence
Background:
- Researchers want to learn if people with alcohol dependence have more difficulty learning to feel calm, or learn to fear things more easily. They also want to study how early life stress (ELS) affects the ability to learn to feel calm.
Read more
Objective:
- To see if people with alcohol dependence and/or ELS have a harder time learning to feel calm than people without these. Also, to see if DNA is changed by ELS and if this change affects fear conditioning and extinction.
Eligibility:
- Adults ages 21-65 with and without an alcohol use disorder (AUD) and with and without ELS.
- Healthy volunteers.
Design:
- Participants will be screened with:
- Medical history
- Physical exam
- Blood and urine tests
- Psychological tests
- Treatment for symptoms of alcohol withdrawal, if needed
- Healthy volunteers will have 1 overnight visit (2 days, 1 night). AUD participants will stay at the clinic for about 4 weeks.
- Participants will:
- Rate alcohol use/craving, depression, anxiety, and childhood trauma.
- Have psychophysiological measures: electrodes and mild electric shock.
- Have a functional magnetic resonance imaging (MRI) scan. Participants will lie on a table in a metal cylinder with a coil over their head. In the first scanning session, they will see pictures, do a simple task, and may get shocks. Participants will also do a second scanning session in which they will perform the aforementioned fear conditioning and extinction task, as well as a facial expression matching task, an affective word processing task, and a task measuring valuation of monetary rewards.
- Answer questions about their emotions (some participants).
- Have blood drawn from an arm vein or intravenous (IV) line.
- AUD participants will get a dexamethasone pill. The next day, they will get a hormone injected in and have blood drawn from an IV line.
- AUD participants will have 3 follow-up visits with questions and blood and lab tests.
Read the detailed description
Objective:
The primary goal of this study is to evaluate the role and interaction of (epi)genetic factors, early life stress (ELS) exposure, and alcohol use disorder (AUD) on neuronal mechanisms of fear conditioning and extinction.
The central hypothesis is that participants with AUD and ELS will have disrupted fear extinction, and in addition, those with ELS will also have disrupted fear extinction. AUD with ELS will have the most severe disruption of fear extinction as observed clinically in alcoholics with severe trauma - often presenting with the most severe phenotypes and being most treatment resistant. A disruption in fear extinction or living in constant fear after stress/trauma could thus put the individual at risk for AUD.
Identification and characterization of the neurobiological correlates underlying this mechanism is thus essential and could provide new avenues for treatment of AUD; namely developing interventions that normalize abnormal fear extinctions. These interventions could be for example, cognitive-behavior based or molecular by targeting genetic/epigenetic pathways potentially identified.
Our proposal, if successful, will first establish a reliable measureable endophenotype of fear extinction in AUD/ELS, both behaviorally (skin conductance response) and neuronal (using an fMRI paradigm). Furthermore, we will carry out exploratory genetic and epigenetics studies that might influence these measures. This model can then be used in follow up studies for novel therapeutic interventions that could target treatment of these mechanisms in AUD.
Study Population:
The study sample includes two patient groups and two control groups:
- treatment-seeking or non-treatment-seeking individuals with AUD and ELS exposure;
- treatment-seeking or non-treatment-seeking individuals with AUD without ELS exposure;
- healthy volunteers with ELS exposure;
- healthy volunteers without ELS exposure.
Target accrual for each of these groups is 25.
Design:
Subjects will be evaluated for fear conditioning and extinction using shock conditioning (extinction procedure combined with fMRI imaging that utilizes galvanic skin response). All participants will undergo whole-genome methylome analyses to assess genome wide methylation patterns. Genotyping of variants in candidate genes implicated in the biology of fear conditioning/extinction will be carried out.
Outcome Parameters:
The primary outcome of interest is fear extinction, measured by fMRI paradigms. Secondary objectives include: (1) explore the role of genetic variants and epigenetic factors and their impact on fear extinction in AUD and healthy controls with or without ELS; (2) explore differences in reward processing and emotion processing, measured by fMRI as a function of AUD, ELS, and (epi)genetic modulators; and (3) examine the relationship between fear extinction and clinical outcomes in both AUD and ELS participants sample.
- Conditions
- Fear, Stress, Alcohol Dependence
- Keywords
- Alcohol, Alcohol Dependence, Stress, Fear Conditioning, Natural History
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AUD/ELS- | Treatment seeking or non-treatment seeking individuals with AUD without ELS exposure | |
| AUD/ELS+ | Treatment-seeking or non-treatment seeking individuals with AUD and early life stress (ELS) exposure | |
| non-AUD/ELS- | non-AUD controls without ELS exposure | |
| non-AUD/ELS+ | Non-AUD controls with ELS exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to evaluate the role and interaction of epigenetic/genetic factors, ELS exposure, and AUD on neuronal mechanisms of fear conditioning and extinction.
- Fear extinction (extinction learning) is disrupted in AUD and differs between normal controls with or without ELS and AUD with or without ELS as measured by behavior (skin conductance response) and by fMRI (region of interest BOLD activation). 1a) AUD with ELS will have more severe disruption in their extinction learning phenotype. 2) Neuronal mechanisms involved in abnormal fear extinction in AUD include decreased vmPFC activation during fear which results in impaired inhibitory top-down control of the amygdala by the mPFC resulting in anxiety.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start13 Aug 2015
- Primary completion30 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Falk W Lohoff, M.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438969
- Sponsor's protocol ID
- 150127
- Other IDs
- 15-AA-0127
- Status last verified
- 13 Feb 2026
- First submitted
- 5 May 2015
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
Publications
Grant BF, Stinson FS, Dawson DA, Chou SP, Dufour MC, Compton W, Pickering RP, Kaplan K. Prevalence and co-occurrence of substance use disorders and independent mood and anxiety disorders: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Arch Gen Psychiatry. 2004 Aug;61(8):807-16. doi: 10.1001/archpsyc.61.8.807.
PubMed 15289279Heilig M, Thorsell A, Sommer WH, Hansson AC, Ramchandani VA, George DT, Hommer D, Barr CS. Translating the neuroscience of alcoholism into clinical treatments: from blocking the buzz to curing the blues. Neurosci Biobehav Rev. 2010 Nov;35(2):334-44. doi: 10.1016/j.neubiorev.2009.11.018. Epub 2009 Nov 24.
PubMed 19941895Goldman D, Oroszi G, Ducci F. The genetics of addictions: uncovering the genes. Nat Rev Genet. 2005 Jul;6(7):521-32. doi: 10.1038/nrg1635.
PubMed 15995696
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Epi)Genetic Modulators of Fear Extinction in Alcohol Dependence
- ClinicalTrials.gov ID
- NCT02438969
- Acronym / sponsor ID
- 150127
- Conditions
- Fear, Stress, Alcohol Dependence
- Keywords
- Alcohol, Alcohol Dependence, Stress, Fear Conditioning, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 13 Aug 2015 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 May 2015 (estimated)
- 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.
Background:
- Researchers want to learn if people with alcohol dependence have more difficulty learning to feel calm, or learn to fear things more easily. They also want to study how early life stress (ELS) affects the ability to learn to feel calm.
Objective:
- To see if people with alcohol dependence and/or ELS have a harder time learning to feel calm than people without these. Also, to see if DNA is changed by ELS and if this change affects fear conditioning and extinction.
Eligibility:
- Adults ages 21-65 with and without an alcohol use disorder (AUD) and with and without ELS.
- Healthy volunteers.
Design:
- Participants will be screened with:
- Medical history
- Physical exam
- Blood and urine tests
- Psychological tests
- Treatment for symptoms of alcohol withdrawal, if needed
- Healthy volunteers will have 1 overnight visit (2 days, 1 night). AUD participants will stay at the clinic for about 4 weeks.
- Participants will:
- Rate alcohol use/craving, depression, anxiety, and childhood trauma.
- Have psychophysiological measures: electrodes and mild electric shock.
- Have a functional magnetic resonance imaging (MRI) scan. Participants will lie on a table in a metal cylinder with a coil over their head. In the first scanning session, they will see pictures, do a simple task, and may get shocks. Participants will also do a second scanning session in which they will perform the aforementioned fear conditioning and extinction task, as well as a facial expression matching task, an affective word processing task, and a task measuring valuation of monetary rewards.
- Answer questions about their emotions (some participants).
- Have blood drawn from an arm vein or intravenous (IV) line.
- AUD participants will get a dexamethasone pill. The next day, they will get a hormone injected in and have blood drawn from an IV line.
- AUD participants will have 3 follow-up visits with questions and blood and lab tests.
Detailed description
Objective:
The primary goal of this study is to evaluate the role and interaction of (epi)genetic factors, early life stress (ELS) exposure, and alcohol use disorder (AUD) on neuronal mechanisms of fear conditioning and extinction.
The central hypothesis is that participants with AUD and ELS will have disrupted fear extinction, and in addition, those with ELS will also have disrupted fear extinction. AUD with ELS will have the most severe disruption of fear extinction as observed clinically in alcoholics with severe trauma - often presenting with the most severe phenotypes and being most treatment resistant. A disruption in fear extinction or living in constant fear after stress/trauma could thus put the individual at risk for AUD.
Identification and characterization of the neurobiological correlates underlying this mechanism is thus essential and could provide new avenues for treatment of AUD; namely developing interventions that normalize abnormal fear extinctions. These interventions could be for example, cognitive-behavior based or molecular by targeting genetic/epigenetic pathways potentially identified.
Our proposal, if successful, will first establish a reliable measureable endophenotype of fear extinction in AUD/ELS, both behaviorally (skin conductance response) and neuronal (using an fMRI paradigm). Furthermore, we will carry out exploratory genetic and epigenetics studies that might influence these measures. This model can then be used in follow up studies for novel therapeutic interventions that could target treatment of these mechanisms in AUD.
Study Population:
The study sample includes two patient groups and two control groups:
- treatment-seeking or non-treatment-seeking individuals with AUD and ELS exposure;
- treatment-seeking or non-treatment-seeking individuals with AUD without ELS exposure;
- healthy volunteers with ELS exposure;
- healthy volunteers without ELS exposure.
Target accrual for each of these groups is 25.
Design:
Subjects will be evaluated for fear conditioning and extinction using shock conditioning (extinction procedure combined with fMRI imaging that utilizes galvanic skin response). All participants will undergo whole-genome methylome analyses to assess genome wide methylation patterns. Genotyping of variants in candidate genes implicated in the biology of fear conditioning/extinction will be carried out.
Outcome Parameters:
The primary outcome of interest is fear extinction, measured by fMRI paradigms. Secondary objectives include: (1) explore the role of genetic variants and epigenetic factors and their impact on fear extinction in AUD and healthy controls with or without ELS; (2) explore differences in reward processing and emotion processing, measured by fMRI as a function of AUD, ELS, and (epi)genetic modulators; and (3) examine the relationship between fear extinction and clinical outcomes in both AUD and ELS participants sample.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AUD/ELS- | – | –Treatment seeking or non-treatment seeking individuals with AUD without ELS exposure |
| AUD/ELS+ | – | –Treatment-seeking or non-treatment seeking individuals with AUD and early life stress (ELS) exposure |
| non-AUD/ELS- | – | –non-AUD controls without ELS exposure |
| non-AUD/ELS+ | – | –Non-AUD controls with ELS exposure |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- AUD participants will be recruited from participants in the NIAAA screening platform protocols 14-AA-0181. Non-AUD participants will be recruited from participants in the NIAAA protocol 14-AA-0181. We will recruit all racial and ethnic groups in the greater Washington DC area
Key inclusion criteria (15 listed)
- Inclusion and exclusion criteria will be evaluated following screening conducted under the NIAAA screening protocols (98-AA-009 and/or 14-AA-0181).
- Between 21 and 65 years of age
- Ability to provide written informed consent as determined by successful completion of consent quiz prior to signing consent
- Females: Negative urine pregnancy test, not currently breastfeeding, agree to abstain or use accepted form of contraception
- Diagnosed with current alcohol dependence according to Diagnostic and Statistical Manual for Mental Disorders-Fourth Edition (DSM IV)
Key exclusion criteria (26 listed)
- Neurological symptoms of the wrist or arm, e.g., carpal tunnel syndrome, as determined by history and physical exam
- Chronic use of psychotropic medications within four weeks of the study, with the exception of fluoxetine, for which the exclusionary time period is six weeks. Incidental use of psychotropic medications is allowed, but any use must be discontinued prior to the study for a time period exceeding 5 half-lives of the medication in question.
- Presence of any current or past DSM IV diagnosis of bipolar disorder, or psychotic disorder (e.g, schizophrenia, schizoaffective disorder), or current substance dependence other than alcohol, nicotine, or caffeine.
- Major medical problems (e.g., central nervous system (CNS), cardiovascular, respiratory, gastrointestinal (GI), hepatic, renal, endocrine, HIV, reproductive) that in the judgment of the PI, in consultation with relevant Clinical Center consult services, cannot be adequately managed at the Clinical Center.
- Presence of ferromagnetic objects in the body, fear of enclosed spaces, or other standard contraindication to MRI, as determined by self-report
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary objective of the study is to evaluate the role and interaction of epigenetic/genetic factors, ELS exposure, and AUD on neuronal mechanisms of fear conditioning and extinction.
Time frame: ongoing
1) Fear extinction (extinction learning) is disrupted in AUD and differs between normal controls with or without ELS and AUD with or without ELS as measured by behavior (skin conductance response) and by fMRI (region of interest BOLD activation). 1a) AUD with ELS will have more severe disruption in their extinction learning phenotype. 2) Neuronal mechanisms involved in abnormal fear extinction in AUD include decreased vmPFC activation during fear which results in impaired inhibitory top-down control of the amygdala by the mPFC resulting in anxiety.
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 3 Nov 2026.
- Background: PubMed 15289279Grant BF, Stinson FS, Dawson DA, Chou SP, Dufour MC, Compton W, Pickering RP, Kaplan K. Prevalence and co-occurrence of substance use disorders and independent mood and anxiety disorders: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Arch Gen Psychiatry. 2004 Aug;61(8):807-16. doi: 10.1001/archpsyc.61.8.807.
- Background: PubMed 19941895Heilig M, Thorsell A, Sommer WH, Hansson AC, Ramchandani VA, George DT, Hommer D, Barr CS. Translating the neuroscience of alcoholism into clinical treatments: from blocking the buzz to curing the blues. Neurosci Biobehav Rev. 2010 Nov;35(2):334-44. doi: 10.1016/j.neubiorev.2009.11.018. Epub 2009 Nov 24.
- Background: PubMed 15995696Goldman D, Oroszi G, Ducci F. The genetics of addictions: uncovering the genes. Nat Rev Genet. 2005 Jul;6(7):521-32. doi: 10.1038/nrg1635.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Falk W Lohoff, M.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fear and Stress, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 15 inclusion and 26 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 3 Nov 2026. 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 primary objective of the study is to evaluate the role and interaction of epigenetic/genetic factors, ELS exposure, and AUD on neuronal mechanisms of fear conditioning and extinction. (time frame: ongoing). 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 NCT02438969, which also lists 3 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 3 Nov 2026.