Underage Alcohol UseNCT03750838
Alcohol Intervention for First Year College Students
A study testing Text Messaging Intervention in people with Underage Alcohol Use, run by University of North Texas Health Science Center at 1 site in United States.
Trial summary
While a large focus of research on U.S. college drinking has focused on the prevalence of and problems related to heavy-episodic drinking, less has focused on college students who are either abstainers or lighter drinkers (i.e., for men, drinking 4 or fewer drinks in two hours and 14 or fewer drinks per week; and for… Read more about this study
- Who is it for?
- Ages 18 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Underage Alcohol Use
- What is being tested?
- Text Messaging Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 19 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligibility criteria includes:
- age 18-19 (see Identity and Age Verification below; If a participant screens in at 18 and turns 20 prior to the focus group, the participant will be allowed to be in the research study.)
- birth date that is consistent with their given age
- first-year college student at the University of North Texas
- valid email address
- have a text messaging plan on their mobile phone
Show all 11Show fewer
- drinking 14/7 or fewer drinks per week for men/women
- no episodes in the past month of consuming 5/4 drinks in two hours for men/women
- express any willingness to take a sip of alcohol
- if female, must not be pregnant or trying to get pregnant
- willing to participate in focus groups at the University of North Texas
Who cannot join
- Not meeting inclusion criteria
- unwillingness to participate
- failure to provide consent (e.g., declining participation in the study)
- providing inconsistent responses (e.g., age) identified by the survey
- having already participated in the study as identified by overlap or consistency in computer IP addresses, contact information, and demographics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Refining and Piloting a Text Messaging Intervention to Delay Alcohol Initiation and Reduce Alcohol Use Escalation Among Abstainer and Lighter Drinker College Students
While a large focus of research on U.S. college drinking has focused on the prevalence of and problems related to heavy-episodic drinking, less has focused on college students who are either abstainers or lighter drinkers (i.e., for men, drinking 4 or fewer drinks in two hours and 14 or fewer drinks per week; and for women drinking 3 or fewer in two hours and 7 or fewer drinks per week). Over 40% percent of college students ages 18-22 do not report drinking in the past month with only half of those engaging in regular heavy-episodic drinking. Research suggests that a significant proportion of students who were abstinent or light drinkers prior to and upon entering college initiate drinking and progress to becoming heavy-episodic drinkers. This provides evidence that the first few months of college is a high-risk time for initiating both drinking and heavy-episodic drinking and that delaying the onset of heavy-episodic drinking among light drinkers and abstainers should lead to reduced harms throughout the college years and young adulthood. Mobile phone-based interventions are an innovative method for reaching young people and have been established as an empirical approach towards addressing health issues, including alcohol use. The ultimate goal of this proposal is to develop, refine and pilot a text message (TM) intervention for abstainer and lighter drinking first year college students with the ultimate goal of delaying alcohol initiation and/or reducing alcohol use escalation. An iterative process of focus groups, intervention content development, and user feedback focused on the unique experiences of abstainers and lighter drinkers will inform the TM Intervention to be delivered in a pilot study with 6 weeks of TMs. The pilot study will include a 6 week post-intervention assessment, and 3, 6, and 9 month follow-ups among 100 incoming first year abstainer and lighter drinker college students. Given that reducing young adults' and college students' engagement in excessive alcohol use has been listed as a major objective of Healthy People 2020 and a key priority of NIAAA, an intervention that focuses on delaying alcohol initiation and escalation into higher-risk alcohol use among abstainer and lighter drinkers could make important strides to achieving this goal.
Read the detailed description
The first year at college, and specifically the first 6 weeks of college, has been identified as a critical period particularly influential to college students' alcohol use trajectories. The prevalence of heavy drinking increases rapidly upon college entry relative to pre-college use and patterns of high-risk alcohol use established during the transition to college can result in a range of adverse consequences that persist throughout the academic year. While a large focus of research on U.S. college drinking has been on the prevalence of and problems related to heavy-episodic drinking (4+/5+ drinks in two hours for women/men), less research has focused on college students who are either abstainers (i.e., do not drink any alcohol) or lighter drinkers (i.e., men: 4 or fewer drinks in two hours and 14 or fewer drinks per week; women: 3 or fewer in two hours and 7 or fewer drinks per week). Research indicates that between 21% and 26% of first-year colleges students who were abstinent or light drinkers before college escalated to heavy episodic drinking during their freshman year. Further, over 40% percent of college students ages 18-22 do not report drinking in the past month, with only half of those engaging in regular heavy-episodic drinking. Research indicates that risk cognitions (i.e., prototypes, norms) are associated with initiation and escalation of alcohol use and also tend to peak around the time that individuals transition out of high school and into a riskier college environment. Delaying the onset of heavy-episodic drinking among abstainers and lighter drinkers during the first-year of college, a particularly high-risk period, should lead to reduced related harms throughout both the college years and young adulthood.
Tailoring intervention approaches to students at various levels of risk, including abstainers or lighter drinkers, may greatly increase efficacy and reduce costs associated with universal interventions (King et al., 2008). No single intervention is likely to sufficiently reduce college drinking or consequences; therefore a "mix of strategies is best". An underexplored strategy is delivering intervention content that reinforces existing reasons for not drinking among abstainers and lighter drinkers, with the goal of delaying the initiation of heavy drinking and/or the escalation to heavy drinking during the first year of college. Given that longitudinal findings indicate that stronger endorsement of reasons for drinking lightly or not drinking, such as academic responsibilities, normative influence, and concern for social images are associated with delayed alcohol initiation, lower levels of alcohol use and higher rates of abstention among young adults, including college students, interventions for abstainers and lighter drinkers that focus on reinforcing proximal reasons not to drink or to drink lightly have promise to dissuade students from initiation of drinking or to delay more hazardous drinking patterns later on.
Additionally, mobile phone-based interventions are an innovative method for reaching young people and have been established as an evidence-based, recommended approach towards addressing health issues including alcohol use. Mobile phone text-messaging (TM) offers an innovative technological approach to brief intervention for college students in a mode in which they are familiar and they already use frequently. Presenting preventative intervention content via TM, especially for abstainer and lighter drinking college students, may be one way to delay alcohol use initiation and prevent the escalation of alcohol use during the first year of college. Therefore, the present project has the following primary aims:
Aim 1: Recruit first year college students who are abstainers and lighter drinkers to examine students' reactions to TM intervention content through an iterative process of focus groups, intervention content development, and user feedback, which will inform a new intervention to be delivered in a pilot study (Aim 3).
Aim 2: Through focus groups, elicit responses to timing of the TM intervention, specifically what days and times per week and how many times per day (set within research-established ranges) abstainer and lighter drinkers think receiving TMs will the most useful and impactful to inform TM delivery for the pilot study (Aim 3).
Aim 3: Conduct a pilot study with 6 weeks of TM intervention content, a 6 week post-intervention assessment and 3, 6, and 9 month follow-ups among 100 abstainer or lighter drinking first-year college students to determine feasibility, acceptability, and preliminary effect sizes (to estimate power and sample sizes for a future R01). Newly enrolled first-year college students will be randomized to the TM intervention or assessment only control. The investigators hypothesize the TM Intervention will be feasible and acceptable to abstainer and lighter drinking students, including being accessible, usable, convenient, relevant and helpful. The investigators further hypothesize that receiving the TM intervention will be associated with less initiation and escalation of drinking, fewer negative consequences, more favorable prototypes of abstainers and lighter drinkers, greater perceived abstaining and light drinking norms, greater engagement and enjoyment of alternative activities, and greater endorsement of personal goals that do not involve alcohol at the 6 week post-intervention assessment and 3, 6, and 9 month follow-ups relative to assessment only control.
- Conditions
- Underage Alcohol Use
- Being tested
- Text Messaging Intervention
- Medical subject headings
- Underage Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Messaging InterventionBehavioural
The content for the text messaging Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.
| Study group | Role | What they receive |
|---|---|---|
| Text Messaging Intervention Group | Experimental | Participants in the Text Messaging Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. Receives: Behavioral: Text Messaging Intervention |
| Assessment Only Control | No intervention | Participants in the assessment only control will not receive any text messages, but will complete all survey assessments on the same schedule as the Text Message Intervention Group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability-Number of Participants Who Found the Study Overall Favorable
Item assessing whether participants found the study overall favorable as measured at 6-week follow-up.
Measured: 6 weeks
Acceptability-proportion of Participants Who Would Recommend the Study
Item assessed by asking whether participants would recommend the study to other first-year college students
Measured: 6 weeks
Acceptability and Feasibility-ratings of Text Message Content Areas
Text Message Rating Scale- assessed ratings of text message intervention content areas with a minimum value of 0 and a maximum value of 4 with higher numbers being a better outcome (i.e., more acceptable)
Measured: 6 weeks
Secondary outcomes (8)
6 Week Alcohol Initiation (Number of Participants Who Initiated Drinking)
Number of participants who initiated drinking since the baseline assessment
Measured: 6 weeks
3 Month Alcohol Initiation (Number of Participants Who Initiated Drinking)
Number of participants who initiated drinking at the 3 month assessment since the 6 week assessment
Measured: 3 months
6 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)
Number of participants who initiated alcohol use at 6 month assessment since the 3 month assessment
Measured: 6 months
9 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)
Number of participants who initiated drinking at 9 month assessment since the 6 month assessment
Measured: 9 months
6 Week Alcohol Quantity (Number of Drinks Per Week)
Number of drinks consumed each week as measured at 6 week assessment
Measured: 6 weeks
3 Month Alcohol Quantity (Number of Drinks)
Number of drinks consumed each week as measured at 3 month assessment
Measured: 3 months
6 Month Alcohol Quantity (Number of Drinks Consumed Per Week)
Number of drinks consumed each week as measured at 6 month assessment
Measured: 6 months
9 Month Alcohol Quantity (Number of Drinks Consumed Per Week)
Number of drinks consumed each week as measured at 9 month assessment
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Jun 2021
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Underage Alcohol UseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Dana Litt, PhD., University of North Texas Health Science Center
- Investigators
- Dana M Litt, PhD., Principal investigator, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750838
- Sponsor's protocol ID
- R34AA026004
- Other IDs
- 1R34AA026004-01A1
- Status last verified
- Dec 2023
- First submitted
- 20 Nov 2018
- Last updated
- 19 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A select number of researchers will have access to unidentified participant data at the close of the study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refining and Piloting a Text Messaging Intervention to Delay Alcohol Initiation and Reduce Alcohol Use Escalation Among Abstainer and Lighter Drinker College Students
- ClinicalTrials.gov ID
- NCT03750838
- Acronym / sponsor ID
- R34AA026004
- Conditions
- Underage Alcohol Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Posted 19 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While a large focus of research on U.S. college drinking has focused on the prevalence of and problems related to heavy-episodic drinking, less has focused on college students who are either abstainers or lighter drinkers (i.e., for men, drinking 4 or fewer drinks in two hours and 14 or fewer drinks per week; and for women drinking 3 or fewer in two hours and 7 or fewer drinks per week). Over 40% percent of college students ages 18-22 do not report drinking in the past month with only half of those engaging in regular heavy-episodic drinking. Research suggests that a significant proportion of students who were abstinent or light drinkers prior to and upon entering college initiate drinking and progress to becoming heavy-episodic drinkers. This provides evidence that the first few months of college is a high-risk time for initiating both drinking and heavy-episodic drinking and that delaying the onset of heavy-episodic drinking among light drinkers and abstainers should lead to reduced harms throughout the college years and young adulthood. Mobile phone-based interventions are an innovative method for reaching young people and have been established as an empirical approach towards addressing health issues, including alcohol use. The ultimate goal of this proposal is to develop, refine and pilot a text message (TM) intervention for abstainer and lighter drinking first year college students with the ultimate goal of delaying alcohol initiation and/or reducing alcohol use escalation. An iterative process of focus groups, intervention content development, and user feedback focused on the unique experiences of abstainers and lighter drinkers will inform the TM Intervention to be delivered in a pilot study with 6 weeks of TMs. The pilot study will include a 6 week post-intervention assessment, and 3, 6, and 9 month follow-ups among 100 incoming first year abstainer and lighter drinker college students. Given that reducing young adults' and college students' engagement in excessive alcohol use has been listed as a major objective of Healthy People 2020 and a key priority of NIAAA, an intervention that focuses on delaying alcohol initiation and escalation into higher-risk alcohol use among abstainer and lighter drinkers could make important strides to achieving this goal.
Detailed description
The first year at college, and specifically the first 6 weeks of college, has been identified as a critical period particularly influential to college students' alcohol use trajectories. The prevalence of heavy drinking increases rapidly upon college entry relative to pre-college use and patterns of high-risk alcohol use established during the transition to college can result in a range of adverse consequences that persist throughout the academic year. While a large focus of research on U.S. college drinking has been on the prevalence of and problems related to heavy-episodic drinking (4+/5+ drinks in two hours for women/men), less research has focused on college students who are either abstainers (i.e., do not drink any alcohol) or lighter drinkers (i.e., men: 4 or fewer drinks in two hours and 14 or fewer drinks per week; women: 3 or fewer in two hours and 7 or fewer drinks per week). Research indicates that between 21% and 26% of first-year colleges students who were abstinent or light drinkers before college escalated to heavy episodic drinking during their freshman year. Further, over 40% percent of college students ages 18-22 do not report drinking in the past month, with only half of those engaging in regular heavy-episodic drinking. Research indicates that risk cognitions (i.e., prototypes, norms) are associated with initiation and escalation of alcohol use and also tend to peak around the time that individuals transition out of high school and into a riskier college environment. Delaying the onset of heavy-episodic drinking among abstainers and lighter drinkers during the first-year of college, a particularly high-risk period, should lead to reduced related harms throughout both the college years and young adulthood.
Tailoring intervention approaches to students at various levels of risk, including abstainers or lighter drinkers, may greatly increase efficacy and reduce costs associated with universal interventions (King et al., 2008). No single intervention is likely to sufficiently reduce college drinking or consequences; therefore a "mix of strategies is best". An underexplored strategy is delivering intervention content that reinforces existing reasons for not drinking among abstainers and lighter drinkers, with the goal of delaying the initiation of heavy drinking and/or the escalation to heavy drinking during the first year of college. Given that longitudinal findings indicate that stronger endorsement of reasons for drinking lightly or not drinking, such as academic responsibilities, normative influence, and concern for social images are associated with delayed alcohol initiation, lower levels of alcohol use and higher rates of abstention among young adults, including college students, interventions for abstainers and lighter drinkers that focus on reinforcing proximal reasons not to drink or to drink lightly have promise to dissuade students from initiation of drinking or to delay more hazardous drinking patterns later on.
Additionally, mobile phone-based interventions are an innovative method for reaching young people and have been established as an evidence-based, recommended approach towards addressing health issues including alcohol use. Mobile phone text-messaging (TM) offers an innovative technological approach to brief intervention for college students in a mode in which they are familiar and they already use frequently. Presenting preventative intervention content via TM, especially for abstainer and lighter drinking college students, may be one way to delay alcohol use initiation and prevent the escalation of alcohol use during the first year of college. Therefore, the present project has the following primary aims:
Aim 1: Recruit first year college students who are abstainers and lighter drinkers to examine students' reactions to TM intervention content through an iterative process of focus groups, intervention content development, and user feedback, which will inform a new intervention to be delivered in a pilot study (Aim 3).
Aim 2: Through focus groups, elicit responses to timing of the TM intervention, specifically what days and times per week and how many times per day (set within research-established ranges) abstainer and lighter drinkers think receiving TMs will the most useful and impactful to inform TM delivery for the pilot study (Aim 3).
Aim 3: Conduct a pilot study with 6 weeks of TM intervention content, a 6 week post-intervention assessment and 3, 6, and 9 month follow-ups among 100 abstainer or lighter drinking first-year college students to determine feasibility, acceptability, and preliminary effect sizes (to estimate power and sample sizes for a future R01). Newly enrolled first-year college students will be randomized to the TM intervention or assessment only control. The investigators hypothesize the TM Intervention will be feasible and acceptable to abstainer and lighter drinking students, including being accessible, usable, convenient, relevant and helpful. The investigators further hypothesize that receiving the TM intervention will be associated with less initiation and escalation of drinking, fewer negative consequences, more favorable prototypes of abstainers and lighter drinkers, greater perceived abstaining and light drinking norms, greater engagement and enjoyment of alternative activities, and greater endorsement of personal goals that do not involve alcohol at the 6 week post-intervention assessment and 3, 6, and 9 month follow-ups relative to assessment only control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text Messaging Intervention Group | Experimental | Behavioral: Text Messaging InterventionParticipants in the Text Messaging Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. |
| Assessment Only Control | No intervention | –Participants in the assessment only control will not receive any text messages, but will complete all survey assessments on the same schedule as the Text Message Intervention Group. |
Who may qualify
- Ages
- 18 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- age 18-19 (see Identity and Age Verification below; If a participant screens in at 18 and turns 20 prior to the focus group, the participant will be allowed to be in the research study.)
- birth date that is consistent with their given age
- first-year college student at the University of North Texas
- valid email address
- have a text messaging plan on their mobile phone
Key exclusion criteria (5 listed)
- Not meeting inclusion criteria
- unwillingness to participate
- failure to provide consent (e.g., declining participation in the study)
- providing inconsistent responses (e.g., age) identified by the survey
- having already participated in the study as identified by overlap or consistency in computer IP addresses, contact information, and demographics
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 |
|---|---|---|
| Text Messaging InterventionThe content for the text messaging Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment. | Behavioural | Text Messaging Intervention Group |
Primary outcome
Acceptability-Number of Participants Who Found the Study Overall Favorable
Time frame: 6 weeks
Item assessing whether participants found the study overall favorable as measured at 6-week follow-up.
Acceptability-proportion of Participants Who Would Recommend the Study
Time frame: 6 weeks
Item assessed by asking whether participants would recommend the study to other first-year college students
Acceptability and Feasibility-ratings of Text Message Content Areas
Time frame: 6 weeks
Text Message Rating Scale- assessed ratings of text message intervention content areas with a minimum value of 0 and a maximum value of 4 with higher numbers being a better outcome (i.e., more acceptable)
8 secondary outcomes
6 Week Alcohol Initiation (Number of Participants Who Initiated Drinking)
Time frame: 6 weeks
3 Month Alcohol Initiation (Number of Participants Who Initiated Drinking)
Time frame: 3 months
6 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)
Time frame: 6 months
9 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)
Time frame: 9 months
6 Week Alcohol Quantity (Number of Drinks Per Week)
Time frame: 6 weeks
3 Month Alcohol Quantity (Number of Drinks)
Time frame: 3 months
6 Month Alcohol Quantity (Number of Drinks Consumed Per Week)
Time frame: 6 months
9 Month Alcohol Quantity (Number of Drinks Consumed Per Week)
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. A select number of researchers will have access to unidentified participant data at the close of the study.
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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.
Dana M Litt, PhD. principal investigator
University of North Texas Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messaging Intervention in people with Underage Alcohol Use, run by University of North Texas Health Science Center 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 11 inclusion and 5 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 19 Jan 2024. 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 19 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability-Number of Participants Who Found the Study Overall Favorable (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2024; AzTrials last refreshed its copy on 30 Oct 2026.