Alcohol Use DisorderNCT03191266
Transcranial Magnetic Stimulation for the Treatment of Veterans With Alcohol Use Disorders
A study testing Active rTMS in people with Alcohol Use Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
At least 60% of Veterans with an alcohol use disorder will relapse within 6 months of treatment, irrespective of the type of treatment they receive. This indicates that currently available interventions for treating AUD in Veterans are not effective in helping them achieve long-term sobriety. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Active rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2018to 28 Jun 2024
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study will be open to male and females, regardless of race and ethnic origin, who are in active treatment for an alcohol use disorder (AUD).
- Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for AUD, and alcohol is self-identified as primary substance of misuse.
- Actively in treatment at VA Palo Alto HCS Addiction Treatment Service, and able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participation in study procedures.
- Participants will be accepted if taking medications specifically for the treatment of MDD, cigarette smoking, or for other psychiatric conditions.
- as long as the medications are not documented to lower seizure threshold
- must be stable on any psychotropic medication for at least 1 month prior to enrollment
- it would be clinically contraindicated to require participants to discontinue such medications for research.
- Participants will be abstinent from alcohol and non-prescribed substances for at least 7 consecutive days prior to active or sham rTMS and no participant demonstrates active acute withdrawal symptoms.
Who cannot join
- Psychiatric:
- History of Schizophrenia Spectrum Disorders
- Bipolar Disorders
- A current substance use disorder that exceeds the severity of the AUD
- based on DSM-5 diagnostic criteria
- Current use of an FDA approved medication for treatment of AUD, i.e.:
Show all 35Show fewer
- disulfiram
- acamprosate
- naltrexone
- Active current suicidal intent or plan
- patients with a previous clinical flag for risk for suicide will be required to have an established safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial
- Any form of previous rTMS or electroconvulsive treatment
- Biomedical:
- Including but not limited to uncontrolled thyroid disease
- Unstable congestive heart failure
- Angina
- Other severe cardiac illness as defined by treatment regimen changes in the prior 3 months
- Cerebrovascular accident
- Cancer if < 1 year since end of treatment
- Unstable diabetes
- COPD requiring oxygen supplementation
- Alzheimer's disease
- Parkinson's disease
- Any biomedical implants with ferromagnetic content
- Neurostimulation devices
- Cardiac pacemakers or any magnetic resonance contraindications
- Traumatic brain injury with self-reported or observed loss of consciousness > 30 minutes
- Any primary or traumatically induced seizure disorder
- General:
- Lack of fluency in English
- Wechsler Adult Reading Test below the 7th percentile, i.e.:
- moderate or greater impairment in estimated general intelligence
- Females who are pregnant or actively attempting pregnancy
- conservative exclusion for magnetic resonance research
- Current use of any medication or substance that is documented to lower seizure threshold or has been identified as a contraindication for rTMS treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
About this study
At least 60% of Veterans with an alcohol use disorder will relapse within 6 months of treatment, irrespective of the type of treatment they receive. This indicates that currently available interventions for treating AUD in Veterans are not effective in helping them achieve long-term sobriety. Repetitive transcranial magnetic stimulation (rTMS) is a brain stimulation method that is at the forefront of innovative, non-invasive, and safe treatments for AUD. However, there have been no studies that specifically determined the effectiveness of rTMS treatment for Veterans with AUD. This project will evaluate the effectiveness of rTMS treatment in promoting long-term abstinence in Veterans suffering from AUD. Assisting Veterans in achieving long-term and sustained sobriety is critical because it is associated with the best medical, cognitive, psychiatric, and psychosocial recovery from AUD.
Read the detailed description
Due to COVID-19 restrictions, active recruiting was suspended 31MAR20. Recruitment resumed 1SEP21
The purpose of this study is to evaluate the efficacy of intermittent theta burst repetitive transcranial magnetic stimulation (rTMS) as a treatment for Veterans with an alcohol use disorder (AUD) to decrease the exceedingly high rate of relapse associated with this condition.
At least 60% of those with AUD will experience a major relapse period within 6 months of treatment, irrespective of the intervention (psychosocial and/or pharmacological) employed. Consequently, the high prevalence of AUD and relapse following treatment in Veterans is associated with substantial resource allocation and costs for the DVA Health Care System. Current pharmacological and psychosocial interventions demonstrate only a moderate level of efficacy, which is reflected in the high rate of relapse in AUD.
rTMS is a neurostimulation method that is at the forefront of innovative, non-invasive, and safe treatments for AUD, and the disorders that commonly co-occur with AUD. To reduce the high rate of relapse in Veterans with AUD, it is necessary for interventions to more effectively address the associated neurobiological dysfunction and salient co-occurring conditions. Accordingly, additional rigorously controlled studies are required to determine if intermittent theta burst rTMS is an effective treatment for Veterans with AUD.
Participants will be recruited from VA Palo Alto Health Care System (VAPAHCS) residential substance abuse treatment clinics A double-blind randomized clinical trial with two groups: Active rTMS Treatment Group (Active rTMS) - will receive five treatments (two treatments per day) per week for 2 weeks. Sham Control Treatment group (i.e., identical rTMS experimental procedure, but no active stimulation) will receive the same frequency and duration of rTMS sessions. The proposed rTMS protocol is consistent with the FDA approved treatment regimen employed for major depressive disorders at the VAPAHCS MIRECC. Magnetic resonance imaging (MR) will be completed pre and post rTMS treatment and used to localize the left DLPFC in each participant to optimize rTMS for this region. Active and Sham rTMS groups will complete predictive measures [i.e., MR measures of anterior frontal glutamate level, blood flow, and tissue volume, diffusion tensor imaging, functional connectivity, task-based fMRI] and other outcome measures (i.e., measures of craving, mood, anxiety, neurocognition) immediately pre- and post-completion of the 2 weeks of rTMS sessions. Genetic markers (i.e., brain derived neurotrophic factor plasma levels and polymorphisms) will also be collected. Neuroimaging and genetic measures are necessary to establish potential biomarkers for prediction of rTMS treatment response, which is requisite for therapeutic optimization. For the 6 months following completion of active or sham rTMS treatment, participants will be contacted monthly, via telephone or in person, to complete a brief standardized measure of alcohol and substance use, craving, and psychiatric symptomatology to assess for changes in these variables over the previous 30 days.
This project will deliver completely novel data on the efficacy of intermittent theta burst rTMS for Veterans with AUD during the first 6 months following treatment. Monitoring over the entire first 6 months following treatment is crucial, given relapse within the first 6 months of treatment is robustly related to poor psychosocial functioning over the ensuing 1-3 years. The ultimate goal of this proposal is provide treatment that more effectively promotes sustained abstinence in the Veteran with AUD, as extended abstinence is robustly associated with optimum biomedical, neuropsychological, psychiatric, and psychosocial recovery and functioning.
- Conditions
- Alcohol Use Disorder
- Being tested
- Active rTMS, Sham rTMS
- Keywords
- repetitive transcranial magnetic stimulation, alcohol use disorder, neuroimaging, relapse, Veterans
- Medical subject headings
- Alcoholism, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMSDevice
Active rTMS will receive an intermittent rTMS stimulation protocol.
Sham rTMSDevice
Sham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation.
| Study group | Role | What they receive |
|---|---|---|
| active rTMS | Active comparator | Active rTMS will receive an intermittent rTMS stimulation protocol. Receives: Device: Active rTMS |
| sham rTMS | Sham comparator | Sham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation. Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Abstained From Alcohol
For the 6 months following completion of active or sham rTMS treatment, participants were contacted monthly, via telephone or in person, to complete a brief standardized measure of alcohol and substance use, and psychiatric symptoms to assess for changes in these variables over the previous 30 days.
Measured: 6 months following last TMS session
Secondary outcomes (3)
Glutamate Concentration in the Left Dorsolateral Prefrontal Cortex (as Measured With Single Voxel Spectroscopy)
Determine if baseline glutamate level can serve as a biomarker to differential those participant, in the active rTMS group who main continuous abstinence versus those who resumed alcohol consumption.
Measured: Baseline
Volume in Anterior Frontal Cortical Regions (as Measured With FreeSurfer)
Determine if volume in anterior frontal cortical regions can serve as biomarkers to predict rTMS treatment response in Veterans with AUD who receive active TMS. Specific regions of interest were the left caudal and rostral middle frontal gyrus and left superior frontal gyrus because these regions correspond to the rTMS anatomical target.
Measured: Baseline
BDNF Polymorphisms (as Measured With TaqMan Genotyping Assays or Similar Assays)
Determine if BDNF polymorphisms (rs6265) can serve as biomarkers to predict rTMS treatment response in Veterans with AUD. Analysis focused on comparing Val homozygote frequency, in active rTMS arm participants, who maintained continuous abstinence (Abstinent) versus those who resumed alcohol consumption (Resumed) over the 6-month follow-up period. There were a limited number of participants who completed the genotyping procedure; therefore, results are likely not generalizable.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start15 Apr 2018
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
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 Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Model description
- A double-blind randomized clinical trial with two groups: Active rTMS Treatment Group (Active rTMS) - will receive four to five treatments (two treatments per day) each week for 2 weeks. Sham Control Treatment group (i.e., identical rTMS experimental procedure, but no active stimulation) will receive the same frequency and duration of rTMS sessions. The proposed rTMS protocol is consistent with the FDA approved treatment regimen employed for major depressive disorders.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Timothy C. Durazzo, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191266
- Sponsor's protocol ID
- D2303-R
- Other IDs
- 1I01RX002303-01A2
- Status last verified
- Jan 2026
- First submitted
- 2 Jun 2017
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Final datasets in machine-readable format will be submitted to PubMed Central, which will permit the easiest access All participants will be assigned a subject code, which will have no relationship to any aspect of identifiable private information. Therefore, the data associated with each participant will be completely de-identified. There will be no mechanism by which public users will be able to re-identify participant data (e.g., name, address) with the subject code.
Publications
Durazzo TC, Humphreys K, LaRocca MA. Leadership Styles Experienced During Military Service Predict Later Anhedonic Depressive Symptoms and Self-Efficacy in Veterans With Alcohol Use Disorder. Mil Med. 2024 May 18;189(5-6):e1064-e1071. doi: 10.1093/milmed/usad405.
PubMed 37897693Durazzo TC, McNerney MW, Hansen AM, Gu M, Sacchet MD, Padula CB. BDNF rs6265 Met carriers with alcohol use disorder show greater age-related decline of N-acetylaspartate in left dorsolateral prefrontal cortex. Drug Alcohol Depend. 2023 Jul 1;248:109901. doi: 10.1016/j.drugalcdep.2023.109901. Epub 2023 Apr 28.
PubMed 37146499
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation for the Treatment of Veterans With Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT03191266
- Acronym / sponsor ID
- D2303-R
- Conditions
- Alcohol Use Disorder
- Keywords
- repetitive transcranial magnetic stimulation, alcohol use disorder, neuroimaging, relapse, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At least 60% of Veterans with an alcohol use disorder will relapse within 6 months of treatment, irrespective of the type of treatment they receive. This indicates that currently available interventions for treating AUD in Veterans are not effective in helping them achieve long-term sobriety. Repetitive transcranial magnetic stimulation (rTMS) is a brain stimulation method that is at the forefront of innovative, non-invasive, and safe treatments for AUD. However, there have been no studies that specifically determined the effectiveness of rTMS treatment for Veterans with AUD. This project will evaluate the effectiveness of rTMS treatment in promoting long-term abstinence in Veterans suffering from AUD. Assisting Veterans in achieving long-term and sustained sobriety is critical because it is associated with the best medical, cognitive, psychiatric, and psychosocial recovery from AUD.
Detailed description
Due to COVID-19 restrictions, active recruiting was suspended 31MAR20. Recruitment resumed 1SEP21
The purpose of this study is to evaluate the efficacy of intermittent theta burst repetitive transcranial magnetic stimulation (rTMS) as a treatment for Veterans with an alcohol use disorder (AUD) to decrease the exceedingly high rate of relapse associated with this condition.
At least 60% of those with AUD will experience a major relapse period within 6 months of treatment, irrespective of the intervention (psychosocial and/or pharmacological) employed. Consequently, the high prevalence of AUD and relapse following treatment in Veterans is associated with substantial resource allocation and costs for the DVA Health Care System. Current pharmacological and psychosocial interventions demonstrate only a moderate level of efficacy, which is reflected in the high rate of relapse in AUD.
rTMS is a neurostimulation method that is at the forefront of innovative, non-invasive, and safe treatments for AUD, and the disorders that commonly co-occur with AUD. To reduce the high rate of relapse in Veterans with AUD, it is necessary for interventions to more effectively address the associated neurobiological dysfunction and salient co-occurring conditions. Accordingly, additional rigorously controlled studies are required to determine if intermittent theta burst rTMS is an effective treatment for Veterans with AUD.
Participants will be recruited from VA Palo Alto Health Care System (VAPAHCS) residential substance abuse treatment clinics A double-blind randomized clinical trial with two groups: Active rTMS Treatment Group (Active rTMS) - will receive five treatments (two treatments per day) per week for 2 weeks. Sham Control Treatment group (i.e., identical rTMS experimental procedure, but no active stimulation) will receive the same frequency and duration of rTMS sessions. The proposed rTMS protocol is consistent with the FDA approved treatment regimen employed for major depressive disorders at the VAPAHCS MIRECC. Magnetic resonance imaging (MR) will be completed pre and post rTMS treatment and used to localize the left DLPFC in each participant to optimize rTMS for this region. Active and Sham rTMS groups will complete predictive measures [i.e., MR measures of anterior frontal glutamate level, blood flow, and tissue volume, diffusion tensor imaging, functional connectivity, task-based fMRI] and other outcome measures (i.e., measures of craving, mood, anxiety, neurocognition) immediately pre- and post-completion of the 2 weeks of rTMS sessions. Genetic markers (i.e., brain derived neurotrophic factor plasma levels and polymorphisms) will also be collected. Neuroimaging and genetic measures are necessary to establish potential biomarkers for prediction of rTMS treatment response, which is requisite for therapeutic optimization. For the 6 months following completion of active or sham rTMS treatment, participants will be contacted monthly, via telephone or in person, to complete a brief standardized measure of alcohol and substance use, craving, and psychiatric symptomatology to assess for changes in these variables over the previous 30 days.
This project will deliver completely novel data on the efficacy of intermittent theta burst rTMS for Veterans with AUD during the first 6 months following treatment. Monitoring over the entire first 6 months following treatment is crucial, given relapse within the first 6 months of treatment is robustly related to poor psychosocial functioning over the ensuing 1-3 years. The ultimate goal of this proposal is provide treatment that more effectively promotes sustained abstinence in the Veteran with AUD, as extended abstinence is robustly associated with optimum biomedical, neuropsychological, psychiatric, and psychosocial recovery and functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind randomized clinical trial with two groups: Active rTMS Treatment Group (Active rTMS) - will receive four to five treatments (two treatments per day) each week for 2 weeks. Sham Control Treatment group (i.e., identical rTMS experimental procedure, but no active stimulation) will receive the same frequency and duration of rTMS sessions. The proposed rTMS protocol is consistent with the FDA approved treatment regimen employed for major depressive disorders.
| Arm | Type | Receives |
|---|---|---|
| active rTMS | Active comparator | Device: Active rTMSActive rTMS will receive an intermittent rTMS stimulation protocol. |
| sham rTMS | Sham comparator | Device: Sham rTMSSham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The study will be open to male and females, regardless of race and ethnic origin, who are in active treatment for an alcohol use disorder (AUD).
- Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for AUD, and alcohol is self-identified as primary substance of misuse.
- Actively in treatment at VA Palo Alto HCS Addiction Treatment Service, and able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participation in study procedures.
- Participants will be accepted if taking medications specifically for the treatment of MDD, cigarette smoking, or for other psychiatric conditions.
- Participants will be abstinent from alcohol and non-prescribed substances for at least 7 consecutive days prior to active or sham rTMS and no participant demonstrates active acute withdrawal symptoms.
Key exclusion criteria (35 listed)
- History of Schizophrenia Spectrum Disorders
- Bipolar Disorders
- A current substance use disorder that exceeds the severity of the AUD
- Current use of an FDA approved medication for treatment of AUD, i.e.:
- Active current suicidal intent or plan
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 |
|---|---|---|
| Active rTMSActive rTMS will receive an intermittent rTMS stimulation protocol. | Device | active rTMS |
| Sham rTMSSham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation. | Device | sham rTMS |
Primary outcome
Number of Participants Who Abstained From Alcohol
Time frame: 6 months following last TMS session
For the 6 months following completion of active or sham rTMS treatment, participants were contacted monthly, via telephone or in person, to complete a brief standardized measure of alcohol and substance use, and psychiatric symptoms to assess for changes in these variables over the previous 30 days.
3 secondary outcomes
Glutamate Concentration in the Left Dorsolateral Prefrontal Cortex (as Measured With Single Voxel Spectroscopy)
Time frame: Baseline
Volume in Anterior Frontal Cortical Regions (as Measured With FreeSurfer)
Time frame: Baseline
BDNF Polymorphisms (as Measured With TaqMan Genotyping Assays or Similar Assays)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37897693Durazzo TC, Humphreys K, LaRocca MA. Leadership Styles Experienced During Military Service Predict Later Anhedonic Depressive Symptoms and Self-Efficacy in Veterans With Alcohol Use Disorder. Mil Med. 2024 May 18;189(5-6):e1064-e1071. doi: 10.1093/milmed/usad405.
- Derived from this study: PubMed 37146499Durazzo TC, McNerney MW, Hansen AM, Gu M, Sacchet MD, Padula CB. BDNF rs6265 Met carriers with alcohol use disorder show greater age-related decline of N-acetylaspartate in left dorsolateral prefrontal cortex. Drug Alcohol Depend. 2023 Jul 1;248:109901. doi: 10.1016/j.drugalcdep.2023.109901. Epub 2023 Apr 28.
- Individual participant dataSharing planned: Yes. Final datasets in machine-readable format will be submitted to PubMed Central, which will permit the easiest access All participants will be assigned a subject code, which will have no relationship to any aspect of identifiable private information. Therefore, the data associated with each participant will be completely de-identified. There will be no mechanism by which public users will be able to re-identify participant data (e.g., name, address) with the subject code.
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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.
Timothy C. Durazzo, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS in people with Alcohol Use Disorder, run by VA Office of Research and Development 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 8 inclusion and 35 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 28 Jan 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. Some participants in this study may receive a placebo. 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 28 Jan 2026). 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?
Number of Participants Who Abstained From Alcohol (time frame: 6 months following last TMS session). 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 NCT03191266, 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 28 Jan 2026.