Alcohol DrinkingNCT06442800
Impacts of Alcohol Warning Labels: An Online Experiment
A study testing Liver Cancer, Throat and Mouth Cancer and Colorectal Cancer in people with Alcohol Drinking, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of this experiment is to examine responses to alcohol warning messages about 10 different topics among US adult alcohol consumers. The main questions this experiment aims to answer are: Which warning topics make alcohol consumers in the US want to drink less alcohol? Which warning topics remind alcohol… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Liver Cancer, Throat and Mouth Cancer and Colorectal Cancer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,123 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2024to 14 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21 and older
- Reside in the United States
- Able to complete a survey in English
- Consumed alcohol at least once per week during the past 4 weeks
Who cannot join
- Under the age of 21
- Reside outside of the United States
- Unable to complete a survey in English
- Consumed alcohol less than once per week during the past 4 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Online Randomized Experiment Evaluating the Perceived Effectiveness of Alcohol Warning Labels
The goal of this experiment is to examine responses to alcohol warning messages about 10 different topics among US adult alcohol consumers. The main questions this experiment aims to answer are:
Which warning topics make alcohol consumers in the US want to drink less alcohol? Which warning topics remind alcohol consumers in the US of alcohol's harms? Which warning topics help alcohol consumers in the US learn something new? There will be a total of 20 alcohol messages, 2 messages for each of the 10 topics. For each topic, participants will be randomly assigned to 1 of the 2 messages so that they view a total of 10 alcohol messages. All 10 messages will be shown in random order. Participants will rate each message on how much it makes them want to drink less alcohol, reminds them that drinking can be harmful, and teaches them something new.
Read the detailed description
This study aims to determine which topics in alcohol warning labels are most effective at making US adults who consume alcohol want to drink less alcohol, which topics best remind consumers of alcohol's harms, and which topics are most likely to teach consumers something new. The survey research company NORC at the University of Chicago will recruit a sample of 1,000 US adults ages 21+ who consumed alcohol at least one time per week during the past 4 weeks.
Participants will complete a within-subjects online randomized experiment in which they view and rate messages shown on alcohol containers. Participants will rate each message on perceived message effectiveness (primary outcome), reminding of alcohol's harms (secondary outcome), and learning something new (secondary outcome). These tasks will be repeated for 10 messages, each with a different topic. There will be 9 warning topics (i.e., topics about alcohol's harms) and 1 control topic (i.e., neutral topic not about alcohol's harms). In this within-subjects experiment, the survey will present the topics in random order and participants will view 1 of 2 messages for each topic.
- Conditions
- Alcohol Drinking
- Being tested
- Liver Cancer, Throat and Mouth Cancer, Colorectal Cancer, Multiple Cancers, Liver Disease
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver CancerBehavioural
Participants will view messages about the risk of liver cancer from alcohol consumption.
Throat and Mouth CancerBehavioural
Participants will view messages about the risk of throat and mouth cancer from alcohol consumption.
Colorectal CancerBehavioural
Participants will view messages about the risk of colorectal cancer from alcohol consumption.
Multiple CancersBehavioural
Participants will view messages about the risk of multiple cancers from alcohol consumption.
Liver DiseaseBehavioural
Participants will view messages about the risk of liver disease from alcohol consumption.
HypertensionBehavioural
Participants will view messages about the risk of hypertension from alcohol consumption.
DementiaBehavioural
Participants will view messages about the risk of dementia from alcohol consumption.
Drinking GuidelinesBehavioural
Participants will view messages about guidelines for alcohol consumption.
Current WarningBehavioural
Participants will view the current warning that is required on most alcoholic beverage containers sold in the US.
ControlBehavioural
Participants will view neutral messages unrelated to the harms of alcohol consumption.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Messages | Experimental | Participants will view and rate 10 messages shown on alcohol containers. Receives: Behavioral: Liver Cancer; Behavioral: Throat and Mouth Cancer; Behavioral: Colorectal Cancer; Behavioral: Multiple Cancers; Behavioral: Liver Disease; Behavioral: Hypertension; Behavioral: Dementia; Behavioral: Drinking Guidelines; Behavioral: Current Warning; Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Message Effectiveness
The study will assess perceived message effectiveness using 1 item: "How much does this message make you want to drink less alcohol?" Response options will range from "not at all" (coded as 1) to "a great deal" (coded as 5). Higher scores indicate more perceived message effectiveness. Survey weighted means are reported to account for NORC AmeriSpeak's sampling design to enable results to be statistically representative of the US population of drinkers age >/=21 who drink alcohol.
Measured: Assessed during one-time 15-minute online study survey
Secondary outcomes (2)
Reminding of Alcohol's Harms
The study will assess reminding of alcohol's harms using 1 item: "How much does this message remind you that drinking alcohol can be harmful?" Response options will range from not at all (1) to a great deal (5). Higher scores indicate greater reminding of alcohol's harms. Survey weighted means are reported to account for NORC AmeriSpeak's sampling design to enable results to be statistically representative of the US population of drinkers age >/=21 who drink alcohol.
Measured: Assessed during one-time 15-minute online study survey
Learning Something New
The study will assess learning something new with 1 item: "Did you learn something new from this message?" Response options will be yes (1) and no (0). Proportion of participants who endorsed learning something new (i.e., answered 1). Survey weighted proportions are reported to account for NORC AmeriSpeak's sampling design to enable results to be statistically representative of the US population of drinkers age >/=21 who drink alcohol.
Measured: Assessed during one-time 15-minute online study survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start25 Sep 2024
- Primary completion14 Oct 2024
- Study completion14 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Marissa Hall, PhD, Principal investigator, University of North Carolina, Chapel HillAnna Grummon, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442800
- Sponsor's protocol ID
- 23-1218a
- Other IDs
- 1R01AA030548-01
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 15 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will post de-identified individual participant data in a public repository.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Randomized Experiment Evaluating the Perceived Effectiveness of Alcohol Warning Labels
- ClinicalTrials.gov ID
- NCT06442800
- Acronym / sponsor ID
- 23-1218a
- Conditions
- Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,123 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Posted 15 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this experiment is to examine responses to alcohol warning messages about 10 different topics among US adult alcohol consumers. The main questions this experiment aims to answer are:
Which warning topics make alcohol consumers in the US want to drink less alcohol? Which warning topics remind alcohol consumers in the US of alcohol's harms? Which warning topics help alcohol consumers in the US learn something new? There will be a total of 20 alcohol messages, 2 messages for each of the 10 topics. For each topic, participants will be randomly assigned to 1 of the 2 messages so that they view a total of 10 alcohol messages. All 10 messages will be shown in random order. Participants will rate each message on how much it makes them want to drink less alcohol, reminds them that drinking can be harmful, and teaches them something new.
Detailed description
This study aims to determine which topics in alcohol warning labels are most effective at making US adults who consume alcohol want to drink less alcohol, which topics best remind consumers of alcohol's harms, and which topics are most likely to teach consumers something new. The survey research company NORC at the University of Chicago will recruit a sample of 1,000 US adults ages 21+ who consumed alcohol at least one time per week during the past 4 weeks.
Participants will complete a within-subjects online randomized experiment in which they view and rate messages shown on alcohol containers. Participants will rate each message on perceived message effectiveness (primary outcome), reminding of alcohol's harms (secondary outcome), and learning something new (secondary outcome). These tasks will be repeated for 10 messages, each with a different topic. There will be 9 warning topics (i.e., topics about alcohol's harms) and 1 control topic (i.e., neutral topic not about alcohol's harms). In this within-subjects experiment, the survey will present the topics in random order and participants will view 1 of 2 messages for each topic.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alcohol Messages | Experimental | Behavioral: Liver Cancer, Behavioral: Throat and Mouth Cancer, Behavioral: Colorectal Cancer, Behavioral: Multiple Cancers, Behavioral: Liver Disease, Behavioral: Hypertension, Behavioral: Dementia, Behavioral: Drinking Guidelines, Behavioral: Current Warning, Behavioral: ControlParticipants will view and rate 10 messages shown on alcohol containers. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21 and older
- Reside in the United States
- Able to complete a survey in English
- Consumed alcohol at least once per week during the past 4 weeks
Key exclusion criteria (4 listed)
- Under the age of 21
- Reside outside of the United States
- Unable to complete a survey in English
- Consumed alcohol less than once per week during the past 4 weeks
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 |
|---|---|---|
| Liver CancerParticipants will view messages about the risk of liver cancer from alcohol consumption. | Behavioural | Alcohol Messages |
| Throat and Mouth CancerParticipants will view messages about the risk of throat and mouth cancer from alcohol consumption. | Behavioural | Alcohol Messages |
| Colorectal CancerParticipants will view messages about the risk of colorectal cancer from alcohol consumption. | Behavioural | Alcohol Messages |
| Multiple CancersParticipants will view messages about the risk of multiple cancers from alcohol consumption. | Behavioural | Alcohol Messages |
| Liver DiseaseParticipants will view messages about the risk of liver disease from alcohol consumption. | Behavioural | Alcohol Messages |
| HypertensionParticipants will view messages about the risk of hypertension from alcohol consumption. | Behavioural | Alcohol Messages |
| DementiaParticipants will view messages about the risk of dementia from alcohol consumption. | Behavioural | Alcohol Messages |
| Drinking GuidelinesParticipants will view messages about guidelines for alcohol consumption. | Behavioural | Alcohol Messages |
| Current WarningParticipants will view the current warning that is required on most alcoholic beverage containers sold in the US. | Behavioural | Alcohol Messages |
| ControlParticipants will view neutral messages unrelated to the harms of alcohol consumption. | Behavioural | Alcohol Messages |
Primary outcome
Perceived Message Effectiveness
Time frame: Assessed during one-time 15-minute online study survey
The study will assess perceived message effectiveness using 1 item: "How much does this message make you want to drink less alcohol?" Response options will range from "not at all" (coded as 1) to "a great deal" (coded as 5). Higher scores indicate more perceived message effectiveness. Survey weighted means are reported to account for NORC AmeriSpeak's sampling design to enable results to be statistically representative of the US population of drinkers age >/=21 who drink alcohol.
2 secondary outcomes
Reminding of Alcohol's Harms
Time frame: Assessed during one-time 15-minute online study survey
Learning Something New
Time frame: Assessed during one-time 15-minute online study survey
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Investigators will post de-identified individual participant data in a public repository.
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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.
Marissa Hall, PhD principal investigator
University of North Carolina, Chapel Hill
Anna Grummon, PhD principal investigator
Stanford 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 Liver Cancer, Throat and Mouth Cancer and Colorectal Cancer in people with Alcohol Drinking, run by University of North Carolina, Chapel Hill 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 4 inclusion and 4 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 15 Aug 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2025). 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?
Perceived Message Effectiveness (time frame: Assessed during one-time 15-minute online study survey). 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 15 Aug 2025.