Tobacco UseNCT05849051
Little Cigar and Cigarillo Warnings Among US Adults Who Use LCCs
A study testing Newly developed warnings with images at 30% size and FDA proposed text-only warnings at 30% size in people with Tobacco Use, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The goal of this research is to assess whether little Cigars and cigarillos (LCC) warnings developed by the study team are more effective than the current warnings proposed by FDA for LCC products. A 3-week web-based randomized controlled trial will be conducted in the United States. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Newly developed warnings with images at 30% size and FDA proposed text-only warnings at 30% size
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,029 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2023to 27 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Members of the recruitment panel (the investigators are partnering with a panel provider for recruitment of all participants)
- Agree to provide their honest answers
- Current little cigar and/or cigarillo every day or some day users
- Over 21 years old
- Currently living in US
- Feel comfortable taking a survey in English without help
Show all 14Show fewer
- Feel comfortable taking an online survey without help
- Have an email address that they check regularly
- Have access to the internet at work or home
- Able to read and respond to surveys delivered to their email
- Able to complete 2 surveys that take approximately 20 minutes
- Able to complete a 5 minute survey each day for 20 days
- Able to verify they are not a bot using CAPTCHA
- Able to answer a simple, random math question
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease: Randomized Controlled Trial Among US Adults Who Use LCCs
The goal of this research is to assess whether little Cigars and cigarillos (LCC) warnings developed by the study team are more effective than the current warnings proposed by FDA for LCC products. A 3-week web-based randomized controlled trial will be conducted in the United States. Participants are adult persons who currently use LCCs.
Read the detailed description
In this study, LCC warnings on packs will be electronically presented to participants over time to determine if newly developed LCC warnings increase quit intentions compared to FDA-proposed text-only warnings and a control condition (in which participants do not see LCC packs or warnings.) A daily diary methodology will be employed to present LCC warnings on packs to participants over time. Qualtrics will contact, screen, consent, and administer the survey. To enroll participants, Qualtrics will screen participants using the inclusion criteria and measures and invite eligible participants to enroll in the study.
At the beginning of the baseline survey (day 0), participants will first consent to participate in the study and then complete a questionnaire about their tobacco use and behaviors (e.g., intentions and quit attempts) and other measures of interest. At the end of the baseline questionnaire, survey software will randomly assign participants to one of the 3 study conditions. The three study conditions are 1) Newly developed warnings with images (the six most effective warnings developed by the study team), 2) FDA-proposed text-only warnings, or 3) control condition in which participants will not receive an intervention (no warnings). Participants will be contacted via email each day (at approximately 6 am) to invite them to complete the survey for that day of the study protocol.
For subsequent days (days 1-6, 8-13, 15-20) participants will be contacted and asked to complete a daily survey which will assess their previous day use of LCCs, as well as cigarettes and e-cigarettes. During these daily surveys, participants assigned to condition 1 or 2 (i.e., the warning conditions) will view an image of a little cigar and cigarillo package with a warning according to the participant's condition. Participants within each warning condition will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds before answering questions.
On days 7 and 14 participants will be asked to complete a slightly longer survey with questions about their LCC behaviors including the number of LCCs used in the past week, the number of LCCs butted out because they wanted to smoke less, the number of LCCs forgone, other tobacco use, blunt use, and quit intentions and attempts.
For the post-test on day 21, participants will be asked to complete a longer questionnaire about their current tobacco use and behaviors including current LCC smoking behavior, LCC nicotine dependence, other tobacco product (OTP) use, LCC and OTP quit intentions, and LCC and O
- Conditions
- Tobacco Use
- Being tested
- Newly developed warnings with images at 30% size, FDA proposed text-only warnings at 30% size
- Keywords
- Cigar Warnings, Little Cigar Use, Cigar Use, Cigarillo Use
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newly developed warnings with images at 30% sizeBehavioural
On study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning developed by the study team that includes an image. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds.
FDA proposed text-only warnings at 30% sizeBehavioural
On study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning proposed by the FDA which is text only. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Newly developed warnings with images | Experimental | Participants receive newly developed warnings intervention Receives: Behavioral: Newly developed warnings with images at 30% size |
| FDA proposed text-only warnings | Experimental | Participants receive FDA proposed text only warning intervention Receives: Behavioral: FDA proposed text-only warnings at 30% size |
| Control group, no intervention | No intervention | Participants do not receive an intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
LCC Quit Intentions
Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.
Measured: day 21 (post test)
Secondary outcomes (39)
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant.
Measured: day 1
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 2
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day was reported by participants.
Measured: day 3
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant.
Measured: day 4
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 5
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 6
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 7
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 8
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 9
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 10
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 11
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 12
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 13
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 14
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 15
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 16
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 17
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 18
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 19
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 20
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Measured: day 21 (post test)
Number of Days Smoked LCCs in Past Week
The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week
Measured: day 7
Number of Days Smoked LCCs in Past Week
The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week
Measured: day 14
Number of Days Smoked LCCs in Past Week
The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week
Measured: day 21 (post test)
Number of LCCs Smoked in the Past Week
The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant
Measured: day 7
Number of LCCs Smoked in the Past Week
The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant
Measured: day 14
Number of LCCs Smoked in the Past Week
The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant
Measured: day 21 (post test)
Number of LCCs Butted Out in the Past Week
The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week
Measured: day 7
Number of LCCs Butted Out in the Past Week
The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week
Measured: day 14
Number of LCCs Butted Out in the Past Week
The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week
Measured: day 21 (post test)
Number of LCCs Forgone in the Past Week
The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week
Measured: day 7
Number of LCCs Forgone in the Past Week
The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week
Measured: day 14
Number of LCCs Forgone in the Past Week
The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week
Measured: day 21 (post test)
LCC Quit Attempts in Past Week
The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week
Measured: day 7
LCC Quit Attempts in Past Week
The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week
Measured: day 14
LCC Quit Attempts in Past Week
The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week
Measured: day 21 (post test)
LCC Quit Intentions
Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.
Measured: day 7
LCC Quit Intentions
Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.
Measured: day 14
Self Reported Learning
Mean self-reported learning reported by participants. Self-reported learning measured with one item on a 1 to 5 scale, where 1 indicates no learning, and 5 indicates a great deal of learning from the warnings in the study. Self reported learning is only measured in conditions 1 and 2, the conditions that receive warnings.
Measured: day 21 (post test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start22 May 2023
- Primary completion27 Aug 2023
- Study completion27 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,029 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Adam O Goldstein, Principal investigator, the University of North Carolina (UNC) Department of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849051
- Sponsor's protocol ID
- 22-2531
- Other IDs
- R01CA240732
- Status last verified
- Jan 2025
- First submitted
- 26 Apr 2023
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will make data collection instruments available for public use after data collection and analyses are complete. On request, the investigators will also make data sets available, stripped of individual identifiers, following publication of the study's main findings.
Publications
Goldstein AO, Jarman KL, Ranney LM, Cornacchione Ross J, Kowitt SD, Enyioha C, Clark SA, Sheeran P, Thrasher JF, Jenson D, Vielot NA. Little Cigar and Cigarillo Graphic Health Warnings and Quitting Behaviors: A Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2526799. doi: 10.1001/jamanetworkopen.2025.26799.
PubMed 40815515
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease: Randomized Controlled Trial Among US Adults Who Use LCCs
- ClinicalTrials.gov ID
- NCT05849051
- Acronym / sponsor ID
- 22-2531
- Conditions
- Tobacco Use
- Keywords
- Cigar Warnings, Little Cigar Use, Cigar Use, Cigarillo Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,029 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 27 Aug 2023 (actual)
- Study completion
- 27 Aug 2023 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Posted 8 Jan 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 research is to assess whether little Cigars and cigarillos (LCC) warnings developed by the study team are more effective than the current warnings proposed by FDA for LCC products. A 3-week web-based randomized controlled trial will be conducted in the United States. Participants are adult persons who currently use LCCs.
Detailed description
In this study, LCC warnings on packs will be electronically presented to participants over time to determine if newly developed LCC warnings increase quit intentions compared to FDA-proposed text-only warnings and a control condition (in which participants do not see LCC packs or warnings.) A daily diary methodology will be employed to present LCC warnings on packs to participants over time. Qualtrics will contact, screen, consent, and administer the survey. To enroll participants, Qualtrics will screen participants using the inclusion criteria and measures and invite eligible participants to enroll in the study.
At the beginning of the baseline survey (day 0), participants will first consent to participate in the study and then complete a questionnaire about their tobacco use and behaviors (e.g., intentions and quit attempts) and other measures of interest. At the end of the baseline questionnaire, survey software will randomly assign participants to one of the 3 study conditions. The three study conditions are 1) Newly developed warnings with images (the six most effective warnings developed by the study team), 2) FDA-proposed text-only warnings, or 3) control condition in which participants will not receive an intervention (no warnings). Participants will be contacted via email each day (at approximately 6 am) to invite them to complete the survey for that day of the study protocol.
For subsequent days (days 1-6, 8-13, 15-20) participants will be contacted and asked to complete a daily survey which will assess their previous day use of LCCs, as well as cigarettes and e-cigarettes. During these daily surveys, participants assigned to condition 1 or 2 (i.e., the warning conditions) will view an image of a little cigar and cigarillo package with a warning according to the participant's condition. Participants within each warning condition will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds before answering questions.
On days 7 and 14 participants will be asked to complete a slightly longer survey with questions about their LCC behaviors including the number of LCCs used in the past week, the number of LCCs butted out because they wanted to smoke less, the number of LCCs forgone, other tobacco use, blunt use, and quit intentions and attempts.
For the post-test on day 21, participants will be asked to complete a longer questionnaire about their current tobacco use and behaviors including current LCC smoking behavior, LCC nicotine dependence, other tobacco product (OTP) use, LCC and OTP quit intentions, and LCC and O
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Newly developed warnings with images | Experimental | Behavioral: Newly developed warnings with images at 30% sizeParticipants receive newly developed warnings intervention |
| FDA proposed text-only warnings | Experimental | Behavioral: FDA proposed text-only warnings at 30% sizeParticipants receive FDA proposed text only warning intervention |
| Control group, no intervention | No intervention | –Participants do not receive an intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Members of the recruitment panel (the investigators are partnering with a panel provider for recruitment of all participants)
- Agree to provide their honest answers
- Current little cigar and/or cigarillo every day or some day users
- Over 21 years old
- Currently living in US
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Newly developed warnings with images at 30% sizeOn study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning developed by the study team that includes an image. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds. | Behavioural | Newly developed warnings with images |
| FDA proposed text-only warnings at 30% sizeOn study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning proposed by the FDA which is text only. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds. | Behavioural | FDA proposed text-only warnings |
Primary outcome
LCC Quit Intentions
Time frame: day 21 (post test)
Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.
39 secondary outcomes
Number of LCCs Smoked in Past Day
Time frame: day 1
Number of LCCs Smoked in Past Day
Time frame: day 2
Number of LCCs Smoked in Past Day
Time frame: day 3
Number of LCCs Smoked in Past Day
Time frame: day 4
Number of LCCs Smoked in Past Day
Time frame: day 5
Number of LCCs Smoked in Past Day
Time frame: day 6
Number of LCCs Smoked in Past Day
Time frame: day 7
Number of LCCs Smoked in Past Day
Time frame: day 8
Number of LCCs Smoked in Past Day
Time frame: day 9
Number of LCCs Smoked in Past Day
Time frame: day 10
Number of LCCs Smoked in Past Day
Time frame: day 11
Number of LCCs Smoked in Past Day
Time frame: day 12
Number of LCCs Smoked in Past Day
Time frame: day 13
Number of LCCs Smoked in Past Day
Time frame: day 14
Number of LCCs Smoked in Past Day
Time frame: day 15
Number of LCCs Smoked in Past Day
Time frame: day 16
Number of LCCs Smoked in Past Day
Time frame: day 17
Number of LCCs Smoked in Past Day
Time frame: day 18
Number of LCCs Smoked in Past Day
Time frame: day 19
Number of LCCs Smoked in Past Day
Time frame: day 20
Number of LCCs Smoked in Past Day
Time frame: day 21 (post test)
Number of Days Smoked LCCs in Past Week
Time frame: day 7
Number of Days Smoked LCCs in Past Week
Time frame: day 14
Number of Days Smoked LCCs in Past Week
Time frame: day 21 (post test)
Number of LCCs Smoked in the Past Week
Time frame: day 7
Number of LCCs Smoked in the Past Week
Time frame: day 14
Number of LCCs Smoked in the Past Week
Time frame: day 21 (post test)
Number of LCCs Butted Out in the Past Week
Time frame: day 7
Number of LCCs Butted Out in the Past Week
Time frame: day 14
Number of LCCs Butted Out in the Past Week
Time frame: day 21 (post test)
Number of LCCs Forgone in the Past Week
Time frame: day 7
Number of LCCs Forgone in the Past Week
Time frame: day 14
Number of LCCs Forgone in the Past Week
Time frame: day 21 (post test)
LCC Quit Attempts in Past Week
Time frame: day 7
LCC Quit Attempts in Past Week
Time frame: day 14
LCC Quit Attempts in Past Week
Time frame: day 21 (post test)
LCC Quit Intentions
Time frame: day 7
LCC Quit Intentions
Time frame: day 14
Self Reported Learning
Time frame: day 21 (post test)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40815515Goldstein AO, Jarman KL, Ranney LM, Cornacchione Ross J, Kowitt SD, Enyioha C, Clark SA, Sheeran P, Thrasher JF, Jenson D, Vielot NA. Little Cigar and Cigarillo Graphic Health Warnings and Quitting Behaviors: A Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2526799. doi: 10.1001/jamanetworkopen.2025.26799.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The investigators will make data collection instruments available for public use after data collection and analyses are complete. On request, the investigators will also make data sets available, stripped of individual identifiers, following publication of the study's main findings.
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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.
Adam O Goldstein principal investigator
the University of North Carolina (UNC) Department of Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Newly developed warnings with images at 30% size and FDA proposed text-only warnings at 30% size in people with Tobacco Use, run by UNC Lineberger Comprehensive Cancer 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 14 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 8 Jan 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 8 Jan 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?
LCC Quit Intentions (time frame: day 21 (post test)). 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 NCT05849051, 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 8 Jan 2025.