Alcohol Use DisorderPhase 2/3NCT05748639
Integrated Digital Intervention for Alcohol Use Disorder
A Phase 2/3 study testing Mobile health application and Medical Management in people with Alcohol Use Disorder, run by Quit Genius at 1 site in United States.
Trial summary
This study is a two-arm randomized clinical trial comparing the Quit Genius intervention for alcohol use disorder (QG-A) to usual care (TAU), comprising medical management of alcohol use disorders with pharmacotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Mobile health application and Medical Management
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 15 Jul 2025
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or older;
- A US resident;
- Using Apple iPhone (5th generation or higher) or Android phone (version 18 or higher);
- Diagnostic and Statistical Manual-V diagnosis of either a moderate or severe Alcohol Use Disorder;
- Currently has health insurance;
- Able to provide informed consent;
Show all 10Show fewer
- Currently employed;
- Willing and able to participate in study procedures;
- Willing to take naltrexone; and
- Good general health or, in the case of a medical/psychiatric condition needing ongoing treatment, potential participants should be under the care of a physician or other qualified healthcare provider with whom the participant provides documented permission to coordinate care with the QG-A care team.
Who cannot join
- Known sensitivity to naltrexone;
- Pregnant, breast feeding, or unwilling to use contraceptive methods;
- Presence of serious medical or psychiatric disorders that would, in the opinion of the medical provider, make participation hazardous or regular follow-up unlikely (e.g., suicidal ideation, acute hepatitis, unstable cardiovascular, liver or renal disease);
- A current pattern of alcohol or sedative use, as assessed by the QG-A licensed medical provider, which would preclude safe participation in the study and/or would likely require imminent medical detoxification;
- Having used acamprosate, disulfiram, or naltrexone, within the past 30 days prior to screening;
- Takes an opioid medication on a routine basis for a pain condition or has anticipated/planned surgery that will require opioid maintenance during the study timeframe;
- Has undergone more than one inpatient medical detoxification treatment; and
- Lack of proficiency in English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of an Integrated Digital Cognitive-Behavioral Therapy (CBT) and Pharmacotherapy Intervention for Adults With Alcohol Use Disorders
This study is a two-arm randomized clinical trial comparing the Quit Genius intervention for alcohol use disorder (QG-A) to usual care (TAU), comprising medical management of alcohol use disorders with pharmacotherapy. Participants (N=300) will be randomly assigned to either QG-A or TAU, and will be assessed at baseline, monthly throughout the 6-month intervention phase and at 3 and 6 months post-treatment, to investigate the impact of QG-A, relative to TAU on alcohol use, psychological symptoms, and health service utilization. The primary aim of the study is to evaluate the efficacy of QG-A, relative to TAU in reducing alcohol use and associated mental health and functional outcomes. A secondary aim is to examine the cost-effectiveness of QG-A, including cost savings and impact on productivity.
Read the detailed description
Effective and evidence-based therapies are available for management of Alcohol Use Disorder (AUD) with a variety of pharmacological and psychosocial interventions supported by a sizable clinical trials literature. However, a major barrier in addressing this significant public health issue is the fact that a majority of individuals with AUD are not receiving treatment. Evidence shows that Individuals with problematic alcohol use may be dissuaded from seeking help due to a lack of accessibility of services, stigmatization, low motivation, or cost of treatment.
Traditional methods of treating AUD typically utilize a behavioral, pharmacological or a combination approach. Medication-assisted treatment (MAT) is the use of medications, in combination with psychosocial therapies, to provide an integrated approach to the treatment of substance use disorders. The MAT approach to treating AUD has been widely successful, with various combinations of pharmacotherapy and psychosocial interventions showing efficacy in the reduction of alcohol use. In particular, the combination of psychosocial therapies such as CBT, MET and 12 steps have proven highly successful when used in combination with the opioid receptor antagonist Naltrexone (NTX). Yet, a lack of accessibility, practicality and adherence to traditional methods has left many alcohol users without the means to effectively deal with their addictions.
Digital therapeutics can address these issues and provide advantages including anonymity, convenience, accessibility, cost-effectiveness, and privacy. Digital therapies can also target individuals with problematic alcohol use who are in different psychological stages of change, allowing potential users to investigate treatment options without the stigma associated with face-to-face interactions. Additionally, these digitized evidence-based therapies have the potential to increase treatment adherence, and because the content is standardized, it can be delivered with greater consistency than face-to-face therapy, lending itself to a clinical research approach.
Quit Genius Alcohol (QG-A) is a newly developed comprehensive treatment program for AUD, utilizing a combination of a mobile-app, pharmacotherapy, and breath sensor. The mobile app is informed by the principles of CBT, Motivational Enhancement Therapy (MET), and community reinforcement. QG delivers personalized, behavioral support adjunct to proven pharmacotherapies to individuals who are seeking to reduce their alcohol consumption. An initial pilot investigation of QG-A demonstrated the feasibility of the intervention as well as some promising preliminary outcomes with regards to alcohol use and related psychological variables that are recognized mechanisms of change in CBT treatment for addicted populations.
As such, the objective of the proposed investigation is to build on the preliminary outcomes and evaluate the effectiveness of QG-A. This study will compare the efficacy of QG-A, which combines CBT based counseling with pharmacotherapy for alcohol use disorders (naltrexone), delivered via an mobile health app (QG-A), relative to usual care for adults with AUD, which comprises medical management with naltrexone (MM), in reducing alcohol use and associated psychological and functional outcomes.
- Conditions
- Alcohol Use Disorder
- Being tested
- Mobile health application, Medical Management
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health applicationOther
Also called QG-A
Participants randomized to receive the QG-A (Experimental) intervention will receive monthly appointments with a medical provider, access to naltrexone, and weekly and bi-weekly appointments with a licensed clinical counselor through an integrated digital health application.
Medical ManagementOther
Also called TAU
Participants randomized to receive the MM (Control) intervention will receive monthly appointments with a medical provider and access to naltrexone.
| Study group | Role | What they receive |
|---|---|---|
| Quit Genius - Alcohol | Experimental | QG-A is a smart phone application targeting alcohol use disorder. QG-A includes standardized cognitive-behavioral therapy in the form of videos, in-app text, audio recordings, and quizzes. The application provides users with information on how to reduce or abstain from alcohol use. Once successfully enrolled in QG-A, a medical provider will evaluate each QG-A participant for appropriateness for pharmacotherapy during an initial 60-minute assessment to confirm an alcohol use disorder diagnosis and collect relevant medical and psychiatric history of the patient. The medical provider will subsequently prescribe oral naltrexone via the QG-A telemedicine platform. A study counselor will provide manualized CBT-based support to QG-A participants via the video telemedicine function, as well as asynchronously via the in-app chat function. Receives: Other: Mobile health application |
| Medical Management | Active comparator | Medical management comprises standard care for alcohol use disorder. A medical provider, upon evaluation of each participant for appropriateness for pharmacotherapy, will subsequently prescribe naltrexone via a non-QG-A telemedicine platform, according to standard clinical practice. Participants will meet with the medical provider monthly over the 6-month course of treatment. In MM, participants receive dose adjustments and brief medical management as normally provided to patients in office-based settings (session duration is 15-20 minutes). The medical provider will deliver education about the study medication and answer any participant questions. Subsequent 15-20 minute sessions will review drinking patterns, overall functioning, medication adherence, and adverse effects. Participants who discontinue medication because of intolerance can continue to attend monthly medical management sessions to support abstinence. Receives: Other: Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use
Change in past 30-day alcohol use
Measured: Baseline to 6-months post-treatment entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Jan 2023
- Primary completion15 Jun 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed as a 2-arm, parallel-group, randomized controlled trial with 12-, 24-, 36-, and 52-week follow-up, to evaluate the effect of the treatment group (QG-A) versus a control group (MM) on alcohol use outcomes.
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quit Genius
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748639
- Sponsor's protocol ID
- QG01
- Status last verified
- Nov 2025
- First submitted
- 17 Feb 2023
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Publications
Bandawar M, Narasimha VL, Chand P. Use of digital technology in addiction disorders. Indian J Psychiatry. 2018 Feb;60(Suppl 4):S534-S540. doi: 10.4103/psychiatry.IndianJPsychiatry_21_18.
PubMed 29540927Singh K, Drouin K, Newmark LP, Lee J, Faxvaag A, Rozenblum R, Pabo EA, Landman A, Klinger E, Bates DW. Many Mobile Health Apps Target High-Need, High-Cost Populations, But Gaps Remain. Health Aff (Millwood). 2016 Dec 1;35(12):2310-2318. doi: 10.1377/hlthaff.2016.0578.
PubMed 27920321Messner E-M, Probst T, O'Rourke T, Stoyanov S, Baumeister H. mHealth Applications: Potentials, Limitations, Current Quality and Future Directions. In: Baumeister H, Montag C, eds. Digital Phenotyping and Mobile Sensing: New Developments in Psychoinformatics. Studies in Neuroscience, Psychology and Behavioral Economics. Springer International Publishing; 2019:235-248. doi:10.1007/978-3-030-31620-4_15
Kranzler HR, Stephenson JJ, Montejano L, Wang S, Gastfriend DR. Persistence with oral naltrexone for alcohol treatment: implications for health-care utilization. Addiction. 2008 Nov;103(11):1801-8. doi: 10.1111/j.1360-0443.2008.02345.x.
PubMed 19032530Hammarlund R, Crapanzano KA, Luce L, Mulligan L, Ward KM. Review of the effects of self-stigma and perceived social stigma on the treatment-seeking decisions of individuals with drug- and alcohol-use disorders. Subst Abuse Rehabil. 2018 Nov 23;9:115-136. doi: 10.2147/SAR.S183256. eCollection 2018.
PubMed 30538599Srisurapanont M, Jarusuraisin N. Naltrexone for the treatment of alcoholism: a meta-analysis of randomized controlled trials. Int J Neuropsychopharmacol. 2005 Jun;8(2):267-80. doi: 10.1017/S1461145704004997.
PubMed 15850502Miller PM, Book SW, Stewart SH. Medical treatment of alcohol dependence: a systematic review. Int J Psychiatry Med. 2011;42(3):227-66. doi: 10.2190/PM.42.3.b.
PubMed 22439295
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of an Integrated Digital Cognitive-Behavioral Therapy (CBT) and Pharmacotherapy Intervention for Adults With Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT05748639
- Acronym / sponsor ID
- QG01
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Quit GeniusIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 1 Mar 2023 (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.
This study is a two-arm randomized clinical trial comparing the Quit Genius intervention for alcohol use disorder (QG-A) to usual care (TAU), comprising medical management of alcohol use disorders with pharmacotherapy. Participants (N=300) will be randomly assigned to either QG-A or TAU, and will be assessed at baseline, monthly throughout the 6-month intervention phase and at 3 and 6 months post-treatment, to investigate the impact of QG-A, relative to TAU on alcohol use, psychological symptoms, and health service utilization. The primary aim of the study is to evaluate the efficacy of QG-A, relative to TAU in reducing alcohol use and associated mental health and functional outcomes. A secondary aim is to examine the cost-effectiveness of QG-A, including cost savings and impact on productivity.
Detailed description
Effective and evidence-based therapies are available for management of Alcohol Use Disorder (AUD) with a variety of pharmacological and psychosocial interventions supported by a sizable clinical trials literature. However, a major barrier in addressing this significant public health issue is the fact that a majority of individuals with AUD are not receiving treatment. Evidence shows that Individuals with problematic alcohol use may be dissuaded from seeking help due to a lack of accessibility of services, stigmatization, low motivation, or cost of treatment.
Traditional methods of treating AUD typically utilize a behavioral, pharmacological or a combination approach. Medication-assisted treatment (MAT) is the use of medications, in combination with psychosocial therapies, to provide an integrated approach to the treatment of substance use disorders. The MAT approach to treating AUD has been widely successful, with various combinations of pharmacotherapy and psychosocial interventions showing efficacy in the reduction of alcohol use. In particular, the combination of psychosocial therapies such as CBT, MET and 12 steps have proven highly successful when used in combination with the opioid receptor antagonist Naltrexone (NTX). Yet, a lack of accessibility, practicality and adherence to traditional methods has left many alcohol users without the means to effectively deal with their addictions.
Digital therapeutics can address these issues and provide advantages including anonymity, convenience, accessibility, cost-effectiveness, and privacy. Digital therapies can also target individuals with problematic alcohol use who are in different psychological stages of change, allowing potential users to investigate treatment options without the stigma associated with face-to-face interactions. Additionally, these digitized evidence-based therapies have the potential to increase treatment adherence, and because the content is standardized, it can be delivered with greater consistency than face-to-face therapy, lending itself to a clinical research approach.
Quit Genius Alcohol (QG-A) is a newly developed comprehensive treatment program for AUD, utilizing a combination of a mobile-app, pharmacotherapy, and breath sensor. The mobile app is informed by the principles of CBT, Motivational Enhancement Therapy (MET), and community reinforcement. QG delivers personalized, behavioral support adjunct to proven pharmacotherapies to individuals who are seeking to reduce their alcohol consumption. An initial pilot investigation of QG-A demonstrated the feasibility of the intervention as well as some promising preliminary outcomes with regards to alcohol use and related psychological variables that are recognized mechanisms of change in CBT treatment for addicted populations.
As such, the objective of the proposed investigation is to build on the preliminary outcomes and evaluate the effectiveness of QG-A. This study will compare the efficacy of QG-A, which combines CBT based counseling with pharmacotherapy for alcohol use disorders (naltrexone), delivered via an mobile health app (QG-A), relative to usual care for adults with AUD, which comprises medical management with naltrexone (MM), in reducing alcohol use and associated psychological and functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is designed as a 2-arm, parallel-group, randomized controlled trial with 12-, 24-, 36-, and 52-week follow-up, to evaluate the effect of the treatment group (QG-A) versus a control group (MM) on alcohol use outcomes.
| Arm | Type | Receives |
|---|---|---|
| Quit Genius - Alcohol | Experimental | Other: Mobile health applicationQG-A is a smart phone application targeting alcohol use disorder. QG-A includes standardized cognitive-behavioral therapy in the form of videos, in-app text, audio recordings, and quizzes. The application provides users with information on how to reduce or abstain from alcohol use. Once successfully enrolled in QG-A, a medical provider will evaluate each QG-A participant for appropriateness for pharmacotherapy during an initial 60-minute assessment to confirm an alcohol use disorder diagnosis and collect relevant medical and psychiatric history of the patient. The medical provider will subsequently prescribe oral naltrexone via the QG-A telemedicine platform. A study counselor will provide manualized CBT-based support to QG-A participants via the video telemedicine function, as well as asynchronously via the in-app chat function. |
| Medical Management | Active comparator | Other: Medical ManagementMedical management comprises standard care for alcohol use disorder. A medical provider, upon evaluation of each participant for appropriateness for pharmacotherapy, will subsequently prescribe naltrexone via a non-QG-A telemedicine platform, according to standard clinical practice. Participants will meet with the medical provider monthly over the 6-month course of treatment. In MM, participants receive dose adjustments and brief medical management as normally provided to patients in office-based settings (session duration is 15-20 minutes). The medical provider will deliver education about the study medication and answer any participant questions. Subsequent 15-20 minute sessions will review drinking patterns, overall functioning, medication adherence, and adverse effects. Participants who discontinue medication because of intolerance can continue to attend monthly medical management sessions to support abstinence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 or older;
- A US resident;
- Using Apple iPhone (5th generation or higher) or Android phone (version 18 or higher);
- Diagnostic and Statistical Manual-V diagnosis of either a moderate or severe Alcohol Use Disorder;
- Currently has health insurance;
Key exclusion criteria (8 listed)
- Known sensitivity to naltrexone;
- Pregnant, breast feeding, or unwilling to use contraceptive methods;
- Presence of serious medical or psychiatric disorders that would, in the opinion of the medical provider, make participation hazardous or regular follow-up unlikely (e.g., suicidal ideation, acute hepatitis, unstable cardiovascular, liver or renal disease);
- A current pattern of alcohol or sedative use, as assessed by the QG-A licensed medical provider, which would preclude safe participation in the study and/or would likely require imminent medical detoxification;
- Having used acamprosate, disulfiram, or naltrexone, within the past 30 days prior to screening;
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 |
|---|---|---|
| Mobile health applicationAlso: QG-AParticipants randomized to receive the QG-A (Experimental) intervention will receive monthly appointments with a medical provider, access to naltrexone, and weekly and bi-weekly appointments with a licensed clinical counselor through an integrated digital health application. | Other | Quit Genius - Alcohol |
| Medical ManagementAlso: TAUParticipants randomized to receive the MM (Control) intervention will receive monthly appointments with a medical provider and access to naltrexone. | Other | Medical Management |
Primary outcome
Alcohol use
Time frame: Baseline to 6-months post-treatment entry
Change in past 30-day alcohol use
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 20 Nov 2025.
- Results publication: PubMed 29540927Bandawar M, Narasimha VL, Chand P. Use of digital technology in addiction disorders. Indian J Psychiatry. 2018 Feb;60(Suppl 4):S534-S540. doi: 10.4103/psychiatry.IndianJPsychiatry_21_18.
- Results publication: PubMed 27920321Singh K, Drouin K, Newmark LP, Lee J, Faxvaag A, Rozenblum R, Pabo EA, Landman A, Klinger E, Bates DW. Many Mobile Health Apps Target High-Need, High-Cost Populations, But Gaps Remain. Health Aff (Millwood). 2016 Dec 1;35(12):2310-2318. doi: 10.1377/hlthaff.2016.0578.
- Results publicationMessner E-M, Probst T, O'Rourke T, Stoyanov S, Baumeister H. mHealth Applications: Potentials, Limitations, Current Quality and Future Directions. In: Baumeister H, Montag C, eds. Digital Phenotyping and Mobile Sensing: New Developments in Psychoinformatics. Studies in Neuroscience, Psychology and Behavioral Economics. Springer International Publishing; 2019:235-248. doi:10.1007/978-3-030-31620-4_15
- Results publication: PubMed 19032530Kranzler HR, Stephenson JJ, Montejano L, Wang S, Gastfriend DR. Persistence with oral naltrexone for alcohol treatment: implications for health-care utilization. Addiction. 2008 Nov;103(11):1801-8. doi: 10.1111/j.1360-0443.2008.02345.x.
- Results publication: PubMed 30538599Hammarlund R, Crapanzano KA, Luce L, Mulligan L, Ward KM. Review of the effects of self-stigma and perceived social stigma on the treatment-seeking decisions of individuals with drug- and alcohol-use disorders. Subst Abuse Rehabil. 2018 Nov 23;9:115-136. doi: 10.2147/SAR.S183256. eCollection 2018.
- Results publication: PubMed 15850502Srisurapanont M, Jarusuraisin N. Naltrexone for the treatment of alcoholism: a meta-analysis of randomized controlled trials. Int J Neuropsychopharmacol. 2005 Jun;8(2):267-80. doi: 10.1017/S1461145704004997.
- Results publication: PubMed 22439295Miller PM, Book SW, Stewart SH. Medical treatment of alcohol dependence: a systematic review. Int J Psychiatry Med. 2011;42(3):227-66. doi: 10.2190/PM.42.3.b.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mobile health application and Medical Management in people with Alcohol Use Disorder, run by Quit Genius 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 10 inclusion and 8 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 20 Nov 2025. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Alcohol use (time frame: Baseline to 6-months post-treatment entry). 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 NCT05748639, which also lists 7 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 20 Nov 2025.