Driving ImpairedNCT05537116
Evaluation of an Interactive Mobile Phone-Based Brief Intervention to Reduce Substance-Impaired Driving
A study testing Personalized feedback, Personalized feedback and text messages and Information Only in people with Driving Impaired, run by Western Kentucky University at 1 site in United States.
Trial summary
Substance-Impaired Driving among emerging adults remains a significant public health concern and may be the single riskiest substance-related outcome among young adults. Brief Interventions (BIs) have been shown to reduce alcohol-impaired driving among this age group, but are not often implemented - despite their… Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Driving Impaired
- What is being tested?
- Personalized feedback, Personalized feedback and text messages and Information Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2022to 31 Mar 2026
- 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 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 or older
- Ability to speak, read, and write in English
- Reports driving after using cannabis prior to driving at least three times in the past three months
- Reports having access to a motor vehicle, a valid driver's license, and plans to drive a vehicle in the next 6 months
- Reports access to a cell phone and willingness to read intervention material and exchange 3 texts post intervention with the study administrator
- Reports a valid email address
Who cannot join
- Currently in treatment for substance use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Interactive Mobile Phone-Based Brief Intervention to Reduce Substance-Impaired Driving Among Emerging Adults
Substance-Impaired Driving among emerging adults remains a significant public health concern and may be the single riskiest substance-related outcome among young adults. Brief Interventions (BIs) have been shown to reduce alcohol-impaired driving among this age group, but are not often implemented - despite their demonstrated efficacy - because it is not economically feasible to deliver in-person BIs to all emerging adult substance users. The present study will be the first to examine whether a text-messaging-based cannabis-impaired driving BI significantly decreases cannabis-impaired driving among emerging adult cannabis users compared to an informational control. Participants will be 149 emerging adults who endorse driving after cannabis use (or combined alcohol and cannabis use) at least three times in the past 3 months. After completing baseline measures, participants will be randomly assigned to receive either: a) substance use information, b) a substance-impaired driving personalized feedback intervention, or c) a substance-impaired driving personalized feedback intervention plus interactive text messages. Participants will complete outcome measures 3 and 6 months post-intervention. Repeated measures mixed modeling analyses will be used to determine whether the intervention significantly reduces substance-impaired driving over time. The project has two specific aims: 1) to evaluate a text based cannabis-impaired driving intervention in a randomized clinical trial, and 2) to determine whether the use of interactive text-messages sustains intervention effects over time.
Read the detailed description
Rates of substance-impaired driving remain especially high among emerging adults, and substance-related traffic accidents remain the leading cause of substance-related death in this age group. Although rates of alcohol-impaired driving (AI-driving) among emerging adults have begun to decrease, rates of driving after cannabis use (DACU) continue to rise. In addition, many emerging adults report simultaneous use of alcohol and cannabis, a behavior that has been shown to increase the odds of substance-impaired driving and results in substantially greater fatal crash risk. Brief Interventions (BIs) have been shown to decrease substance use and related problems.6 BIs attempt to identify and correct faulty normative beliefs and highlight personal consequences of substance use (such as driving after substance use). BIs typically consist of one or two individual therapeutic meetings delivered in motivational interviewing (MI) style and include personalized feedback (based on a series of questionnaires completed by the participant prior to their BI session). One reason why BIs have not been widely implemented- despite their demonstrated efficacy - is that it is not economically feasible for universities and community agencies to hire and train staff to deliver in-person BIs to all substance users, and very few emerging adults seek out substance prevention or treatment services available on campus or in the surrounding community. Innovative ways of delivering BIs to this at-risk population, in a manner that is both effective and economically feasible, need to be developed. Text messaging represents a particularly advantageous way to provide BIs as they can be highly personalized to the individual and allows for engagement and interaction between the interventionist and participant. Research indicates that emerging adults prefer text messages to telephone calls and emails and rate this medium positively. Given the high prevalence and fatal consequences of substance-impaired driving, highly accessible intervention approaches are imperative for reducing this extremely risky behavior.
In the past few years, a number of interventions using text-messaging to target substance use and problems have been developed and evaluated with reviews and meta-analyses suggesting that the majority of these interventions result in improved outcomes and warrant further large scale studies. Most of these interventions target overall substance use and problems and do not focus on specific risk behaviors, such as substance-impaired driving. We have developed and evaluated a mobile-based BI focused specifically on decreasing AI-driving among college students in a pilot trial. This study indicated that a brief, mobile-based AI-driving intervention including MI text messaging resulted in significantly greater reductions in AI-driving at the 3-month follow-up, compared to alcohol information alone. We modified the intervention to focus on driving after cannabis use and found that the intervention resulted in significantly greater increases in perceived dangerousness of DACU and significantly greater decreases in DACU compared to to an informational control condition. Importantly, several recent studies have demonstrated greater effectiveness of interventions that include personal contact vs. those that are fully automated. The present study provides an important bridge between in-person therapist delivered interventions and fully automated interventions by utilizing interactive text messaging with participants in order to enhance retention of intervention elements and provide tailored, individualized interaction. It is imperative to directly test whether the use of interactive text-messages decreases substance-impaired driving significantly more than personalized feedback alone.
The proposed study will extend promising pilot results by: (a) increasing power by recruiting 149 emerging adults reporting recent driving after cannabis use (DACU), (b) including a 6-month follow-up to determine whether intervention effects persist over time, (c) examining mediators of intervention outcomes (e.g., changes in cannabis-related cognitions), and (d) providing additional intervention content focused on decreasing driving after combined use of alcohol and cannabis. The overarching goal is to use mobile technology to reduce driving after substance use among emerging adult cannabis users.
We will conduct a 3-group trial with 149 emerging adults (ages 18-25; project 50% female; 20% minority) recruited from a community in the Southeastern United States.
Group 1: substance impaired driving personalized feedback Group 2: substance impaired driving personalized feedback and Motivational Interviewing (MI) interactive text messages Group 3: substance use information (control) Aim 1: Evaluate a text based substance-impaired driving intervention in a Randomized Clinical Trial.
Hypothesis 1: Group 2 will report greater reductions in driving after cannabis use and driving after simultaneous alcohol and cannabis use 3- and 6-months post-intervention.
Aim 2: Evaluate mechanisms of intervention response. Hypothesis 1: Cognitive factors (e.g., changes in perceptions of dangerousness and consequences, peer norms, cannabis expectancies) will mediate intervention outcomes.
- Conditions
- Driving Impaired
- Being tested
- Personalized feedback, Personalized feedback and text messages, Information Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized feedbackBehavioural
Following the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback. Feedback will include the following elements: a personalized substance use profile and substance-impaired driving profile, information on social norms related to substance use and substance-impaired driving, personalized information on BAC (or level of impairment due to drug use) prior to driving, costs associated with a DUI citation in Kentucky, and information on combined drug and alcohol impaired driving risk (if endorsed).
Personalized feedback and text messagesBehavioural
Following the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback (described above). Participants will be asked to send a text message back to the study administrator after viewing the feedback document. After confirming receipt and processing of the document, the study administrator will then send the participant three text messages containing open-ended questions.
Information OnlyBehavioural
Students randomized to the information condition will receive standard information about alcohol and other drugs and substance-impaired driving via a link to a website delivered through text message.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Feedback | Experimental | Following the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback. Feedback will include the following elements: a personalized substance use profile and substance-impaired driving profile, information on social norms related to substance use and substance-impaired driving, personalized information on BAC (or level of impairment due to drug use) prior to driving, costs associated with a DUI citation in Kentucky, and information on combined drug and alcohol impaired driving risk (if endorsed). Receives: Behavioral: Personalized feedback |
| Personalized feedback and text messages | Experimental | Following the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback (described above). Participants will be asked to send a text message back to the study administrator after viewing the feedback document. After confirming receipt and processing of the document, the study administrator will then send the participant three text messages containing open-ended questions. Receives: Behavioral: Personalized feedback and text messages |
| Information only | Active comparator | Students randomized to the information condition will receive standard information about alcohol and other drugs and substance-impaired driving via a link to a website delivered through text message. Receives: Behavioral: Information Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving After Cannabis Use
Self-reported count of driving-after-cannabis-use episodes during the prior 3 months, assessed at the 3-month post-intervention follow-up.
Measured: 3-month post-intervention follow-up assessment
Driving After Cannabis Use
Self-reported number of times participants drove after cannabis use during the prior 3 months, assessed at the 6-month post-intervention follow-up.
Measured: 6 months post-intervention follow-up assessment
Secondary outcomes (2)
Driving After Combined Alcohol and Cannabis Use
Self-reported number of times participants drove after combined alcohol and cannabis use during the prior 3 months, assessed at the 3-month post-intervention follow-up.
Measured: 3-month post-intervention follow-up assessment
Driving After Combined Alcohol and Cannabis Use
Self-reported number of times participants drove after combined alcohol and cannabis use during the prior 3 months, assessed at the 6-month post-intervention follow-up.
Measured: 6 months post-intervention follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start18 Oct 2022
- Primary completion8 Sep 2025
- Study completion31 Mar 2026
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 (1)Papers the sponsor has linked to this study.
- Other trials for Driving ImpairedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to conditions using a random number generator.
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Kentucky University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenni Teeters, PhD, Principal investigator, Western Kentucky University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537116
- Sponsor's protocol ID
- 22-012
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2022
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final dataset will consist of self-reported data from survey questionnaires and qualitative data from text-messaging sessions. Preliminary data will be shared via a presentation at a national conference in the second and third years of the project. After all data is collected, a manuscript detailing findings from the study will be submitted for peer-review and de-identified data will be submitted to the NIDA data archive.
Publications
Teeters JB, Ramirez AB, Meredith ND. Cannabis use frequency and driving safety: Associations between cannabis use frequency and driving perceptions and behaviors. Psychol Addict Behav. 2026 Mar 19:10.1037/adb0001145. doi: 10.1037/adb0001145. Online ahead of print.
PubMed 41854673
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Interactive Mobile Phone-Based Brief Intervention to Reduce Substance-Impaired Driving Among Emerging Adults
- ClinicalTrials.gov ID
- NCT05537116
- Acronym / sponsor ID
- 22-012
- Conditions
- Driving Impaired
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Western Kentucky UniversityUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Posted 31 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Substance-Impaired Driving among emerging adults remains a significant public health concern and may be the single riskiest substance-related outcome among young adults. Brief Interventions (BIs) have been shown to reduce alcohol-impaired driving among this age group, but are not often implemented - despite their demonstrated efficacy - because it is not economically feasible to deliver in-person BIs to all emerging adult substance users. The present study will be the first to examine whether a text-messaging-based cannabis-impaired driving BI significantly decreases cannabis-impaired driving among emerging adult cannabis users compared to an informational control. Participants will be 149 emerging adults who endorse driving after cannabis use (or combined alcohol and cannabis use) at least three times in the past 3 months. After completing baseline measures, participants will be randomly assigned to receive either: a) substance use information, b) a substance-impaired driving personalized feedback intervention, or c) a substance-impaired driving personalized feedback intervention plus interactive text messages. Participants will complete outcome measures 3 and 6 months post-intervention. Repeated measures mixed modeling analyses will be used to determine whether the intervention significantly reduces substance-impaired driving over time. The project has two specific aims: 1) to evaluate a text based cannabis-impaired driving intervention in a randomized clinical trial, and 2) to determine whether the use of interactive text-messages sustains intervention effects over time.
Detailed description
Rates of substance-impaired driving remain especially high among emerging adults, and substance-related traffic accidents remain the leading cause of substance-related death in this age group. Although rates of alcohol-impaired driving (AI-driving) among emerging adults have begun to decrease, rates of driving after cannabis use (DACU) continue to rise. In addition, many emerging adults report simultaneous use of alcohol and cannabis, a behavior that has been shown to increase the odds of substance-impaired driving and results in substantially greater fatal crash risk. Brief Interventions (BIs) have been shown to decrease substance use and related problems.6 BIs attempt to identify and correct faulty normative beliefs and highlight personal consequences of substance use (such as driving after substance use). BIs typically consist of one or two individual therapeutic meetings delivered in motivational interviewing (MI) style and include personalized feedback (based on a series of questionnaires completed by the participant prior to their BI session). One reason why BIs have not been widely implemented- despite their demonstrated efficacy - is that it is not economically feasible for universities and community agencies to hire and train staff to deliver in-person BIs to all substance users, and very few emerging adults seek out substance prevention or treatment services available on campus or in the surrounding community. Innovative ways of delivering BIs to this at-risk population, in a manner that is both effective and economically feasible, need to be developed. Text messaging represents a particularly advantageous way to provide BIs as they can be highly personalized to the individual and allows for engagement and interaction between the interventionist and participant. Research indicates that emerging adults prefer text messages to telephone calls and emails and rate this medium positively. Given the high prevalence and fatal consequences of substance-impaired driving, highly accessible intervention approaches are imperative for reducing this extremely risky behavior.
In the past few years, a number of interventions using text-messaging to target substance use and problems have been developed and evaluated with reviews and meta-analyses suggesting that the majority of these interventions result in improved outcomes and warrant further large scale studies. Most of these interventions target overall substance use and problems and do not focus on specific risk behaviors, such as substance-impaired driving. We have developed and evaluated a mobile-based BI focused specifically on decreasing AI-driving among college students in a pilot trial. This study indicated that a brief, mobile-based AI-driving intervention including MI text messaging resulted in significantly greater reductions in AI-driving at the 3-month follow-up, compared to alcohol information alone. We modified the intervention to focus on driving after cannabis use and found that the intervention resulted in significantly greater increases in perceived dangerousness of DACU and significantly greater decreases in DACU compared to to an informational control condition. Importantly, several recent studies have demonstrated greater effectiveness of interventions that include personal contact vs. those that are fully automated. The present study provides an important bridge between in-person therapist delivered interventions and fully automated interventions by utilizing interactive text messaging with participants in order to enhance retention of intervention elements and provide tailored, individualized interaction. It is imperative to directly test whether the use of interactive text-messages decreases substance-impaired driving significantly more than personalized feedback alone.
The proposed study will extend promising pilot results by: (a) increasing power by recruiting 149 emerging adults reporting recent driving after cannabis use (DACU), (b) including a 6-month follow-up to determine whether intervention effects persist over time, (c) examining mediators of intervention outcomes (e.g., changes in cannabis-related cognitions), and (d) providing additional intervention content focused on decreasing driving after combined use of alcohol and cannabis. The overarching goal is to use mobile technology to reduce driving after substance use among emerging adult cannabis users.
We will conduct a 3-group trial with 149 emerging adults (ages 18-25; project 50% female; 20% minority) recruited from a community in the Southeastern United States.
Group 1: substance impaired driving personalized feedback Group 2: substance impaired driving personalized feedback and Motivational Interviewing (MI) interactive text messages Group 3: substance use information (control) Aim 1: Evaluate a text based substance-impaired driving intervention in a Randomized Clinical Trial.
Hypothesis 1: Group 2 will report greater reductions in driving after cannabis use and driving after simultaneous alcohol and cannabis use 3- and 6-months post-intervention.
Aim 2: Evaluate mechanisms of intervention response. Hypothesis 1: Cognitive factors (e.g., changes in perceptions of dangerousness and consequences, peer norms, cannabis expectancies) will mediate intervention outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to conditions using a random number generator.
| Arm | Type | Receives |
|---|---|---|
| Personalized Feedback | Experimental | Behavioral: Personalized feedbackFollowing the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback. Feedback will include the following elements: a personalized substance use profile and substance-impaired driving profile, information on social norms related to substance use and substance-impaired driving, personalized information on BAC (or level of impairment due to drug use) prior to driving, costs associated with a DUI citation in Kentucky, and information on combined drug and alcohol impaired driving risk (if endorsed). |
| Personalized feedback and text messages | Experimental | Behavioral: Personalized feedback and text messagesFollowing the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback (described above). Participants will be asked to send a text message back to the study administrator after viewing the feedback document. After confirming receipt and processing of the document, the study administrator will then send the participant three text messages containing open-ended questions. |
| Information only | Active comparator | Behavioral: Information OnlyStudents randomized to the information condition will receive standard information about alcohol and other drugs and substance-impaired driving via a link to a website delivered through text message. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 or older
- Ability to speak, read, and write in English
- Reports driving after using cannabis prior to driving at least three times in the past three months
- Reports having access to a motor vehicle, a valid driver's license, and plans to drive a vehicle in the next 6 months
- Reports access to a cell phone and willingness to read intervention material and exchange 3 texts post intervention with the study administrator
Key exclusion criteria (1 listed)
- Currently in treatment for substance use
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 |
|---|---|---|
| Personalized feedbackFollowing the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback. Feedback will include the following elements: a personalized substance use profile and substance-impaired driving profile, information on social norms related to substance use and substance-impaired driving, personalized information on BAC (or level of impairment due to drug use) prior to driving, costs associated with a DUI citation in Kentucky, and information on combined drug and alcohol impaired driving risk (if endorsed). | Behavioural | Personalized Feedback |
| Personalized feedback and text messagesFollowing the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback (described above). Participants will be asked to send a text message back to the study administrator after viewing the feedback document. After confirming receipt and processing of the document, the study administrator will then send the participant three text messages containing open-ended questions. | Behavioural | Personalized feedback and text messages |
| Information OnlyStudents randomized to the information condition will receive standard information about alcohol and other drugs and substance-impaired driving via a link to a website delivered through text message. | Behavioural | Information only |
Primary outcome
Driving After Cannabis Use
Time frame: 3-month post-intervention follow-up assessment
Self-reported count of driving-after-cannabis-use episodes during the prior 3 months, assessed at the 3-month post-intervention follow-up.
Driving After Cannabis Use
Time frame: 6 months post-intervention follow-up assessment
Self-reported number of times participants drove after cannabis use during the prior 3 months, assessed at the 6-month post-intervention follow-up.
2 secondary outcomes
Driving After Combined Alcohol and Cannabis Use
Time frame: 3-month post-intervention follow-up assessment
Driving After Combined Alcohol and Cannabis Use
Time frame: 6 months post-intervention follow-up assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41854673Teeters JB, Ramirez AB, Meredith ND. Cannabis use frequency and driving safety: Associations between cannabis use frequency and driving perceptions and behaviors. Psychol Addict Behav. 2026 Mar 19:10.1037/adb0001145. doi: 10.1037/adb0001145. Online ahead of print.
- Individual participant dataSharing planned: Yes. The final dataset will consist of self-reported data from survey questionnaires and qualitative data from text-messaging sessions. Preliminary data will be shared via a presentation at a national conference in the second and third years of the project. After all data is collected, a manuscript detailing findings from the study will be submitted for peer-review and de-identified data will be submitted to the NIDA data archive.
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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.
Jenni Teeters, PhD principal investigator
Western Kentucky University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized feedback, Personalized feedback and text messages and Information Only in people with Driving Impaired, run by Western Kentucky University 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 6 inclusion and 1 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 31 Aug 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?
Yes. Results are posted in the registry (first posted 31 Aug 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?
Driving After Cannabis Use (time frame: 3-month post-intervention follow-up assessment). The study lists 2 primary outcomes in all. 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 NCT05537116, which also lists 1 linked publication.
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 31 Aug 2026.