SmokingEarly Phase 1NCT04740008
Impact of Low Nicotine Cigarette Messaging on Perceptions and Cigarette Choices
A Early Phase 1 study testing Low Nicotine Content Cigarettes and Test message in people with Smoking and Cigarette, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
The purpose of this research is to evaluate the effects of low nicotine content cigarette (LNC) educational messaging on perceptions of low nicotine cigarettes, tobacco/nicotine product choice preferences (hypothetical), LNC cigarette subjective ratings, and LNC cigarette abuse liability among adult smokers. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- What is being tested?
- Low Nicotine Content Cigarettes and Test message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2021to 24 Aug 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- At least 21 years of age
- Biochemically confirmed smoker
Who cannot join
- Unstable health condition
- Unstable medications
- Pregnant or nursing
- Unreliable access to a computer, smart phone or tablet without working camera and internet access for telehealth visits and online questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, Tobacco Research Program, 717 Delaware St., SE
Minneapolis, Minnesota, 55455
About this study
Official title: Impact of Low Nicotine Cigarette Messaging on Risk Perceptions and Hypothetical Tobacco and Nicotine Product Choices.
The purpose of this research is to evaluate the effects of low nicotine content cigarette (LNC) educational messaging on perceptions of low nicotine cigarettes, tobacco/nicotine product choice preferences (hypothetical), LNC cigarette subjective ratings, and LNC cigarette abuse liability among adult smokers.
Read the detailed description
This randomized single-site study will assess the subject's risk perceptions and hypothetical tobacco product choices based on their exposure to an educational messaging condition related to nicotine content in cigarettes.
Subjects (N=40 in each group) will be given a pack of low nicotine content cigarettes (LNC; 0.4 mg/g) and will be randomly assigned to read one of two messaging conditions on low nicotine cigarettes.
Smokers will undergo a telephone screening to assess eligibility, then move on to the next steps of the study depending on eligibility:
- Virtual Zoom Screening - Completed after telephone screen: Informed consent is obtained and then an interview where data is collected and eligibility is further assessed.
- Curbside Visit - Completed after the screening and if eligible: Breath test, and if necessary a urine test, is performed to assess smoking levels and urine pregnancy test is attained (if applicable). If eligible, randomization to messaging condition occurs and participants provided a pack of low nicotine content cigarettes.
- Virtual Zoom Home Session - Completed after curbside and if eligible based on curbside: Surveys assessing main outcome variables assessed.
- Follow-up - Completed 1 week after the virtual Zoom session: Interview where assessment of health and product usage is assessed.
Except for the initial telephone screening, participants will receive compensation for each part of the study.
- Being tested
- Low Nicotine Content Cigarettes, Control message, Test message
- Keywords
- Low Nicotine Content, Educational Messaging, Cigarette, Smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Nicotine Content CigarettesDrug
Low Nicotine Content Cigarettes 0.4 mg/g nicotine; 9 mg tar Other Name: Reduced Nicotine Content Cigarettes
Control messageOther
Participants will read control message
Test messageOther
Participants will read test message
| Study group | Role | What they receive |
|---|---|---|
| Control message on low nicotine cigarettes | Experimental | Not described Receives: Drug: Low Nicotine Content Cigarettes; Other: Control message |
| Test message on low nicotine cigarettes | Experimental | Not described Receives: Drug: Low Nicotine Content Cigarettes; Other: Test message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants that choose ANDS or no tobacco
Proportion of participants who select to use ANDS or no tobacco if LNC cigarettes were the only cigarettes available will be compared in arm 1 versus arm 2
Measured: Within 17 days of virtual screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start20 Apr 2021
- Primary completion24 Aug 2022
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana Mowls Carroll, Ph.D., M.P.H, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740008
- Sponsor's protocol ID
- SPH-2020-29384
- Other IDs
- 2020LS214
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2021
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Intend to share findings from this research through publications and presentations. Institutions and individuals wishing to access any resources or data must contact the Principal Investigator (Carroll). Data will be available in two formats. One will be a summary of the data, with graphs and tables, posted as pdf files and as raw individual-level data for analysis. Data generated by this grant will be made to outside investigators, according to NIH Guidance. When data are shared, there will be no limits placed on how the data will be used. Users will agree, however, that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. A record of transfer of data and a copy of the dataset that was distributed will be kept by University of Minnesota
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Low Nicotine Cigarette Messaging on Risk Perceptions and Hypothetical Tobacco and Nicotine Product Choices.
- ClinicalTrials.gov ID
- NCT04740008
- Acronym / sponsor ID
- SPH-2020-29384
- Keywords
- Low Nicotine Content, Educational Messaging, Cigarette, Smoking
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to evaluate the effects of low nicotine content cigarette (LNC) educational messaging on perceptions of low nicotine cigarettes, tobacco/nicotine product choice preferences (hypothetical), LNC cigarette subjective ratings, and LNC cigarette abuse liability among adult smokers.
Detailed description
This randomized single-site study will assess the subject's risk perceptions and hypothetical tobacco product choices based on their exposure to an educational messaging condition related to nicotine content in cigarettes.
Subjects (N=40 in each group) will be given a pack of low nicotine content cigarettes (LNC; 0.4 mg/g) and will be randomly assigned to read one of two messaging conditions on low nicotine cigarettes.
Smokers will undergo a telephone screening to assess eligibility, then move on to the next steps of the study depending on eligibility:
- Virtual Zoom Screening - Completed after telephone screen: Informed consent is obtained and then an interview where data is collected and eligibility is further assessed.
- Curbside Visit - Completed after the screening and if eligible: Breath test, and if necessary a urine test, is performed to assess smoking levels and urine pregnancy test is attained (if applicable). If eligible, randomization to messaging condition occurs and participants provided a pack of low nicotine content cigarettes.
- Virtual Zoom Home Session - Completed after curbside and if eligible based on curbside: Surveys assessing main outcome variables assessed.
- Follow-up - Completed 1 week after the virtual Zoom session: Interview where assessment of health and product usage is assessed.
Except for the initial telephone screening, participants will receive compensation for each part of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control message on low nicotine cigarettes | Experimental | Drug: Low Nicotine Content Cigarettes, Other: Control message |
| Test message on low nicotine cigarettes | Experimental | Drug: Low Nicotine Content Cigarettes, Other: Test message |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female
- At least 21 years of age
- Biochemically confirmed smoker
Key exclusion criteria (4 listed)
- Unstable health condition
- Unstable medications
- Pregnant or nursing
- Unreliable access to a computer, smart phone or tablet without working camera and internet access for telehealth visits and online questionnaires
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 |
|---|---|---|
| Low Nicotine Content CigarettesLow Nicotine Content Cigarettes 0.4 mg/g nicotine; 9 mg tar Other Name: Reduced Nicotine Content Cigarettes | Drug | Control message on low nicotine cigarettes, Test message on low nicotine cigarettes |
| Control messageParticipants will read control message | Other | Control message on low nicotine cigarettes |
| Test messageParticipants will read test message | Other | Test message on low nicotine cigarettes |
Primary outcome
Proportion of participants that choose ANDS or no tobacco
Time frame: Within 17 days of virtual screening
Proportion of participants who select to use ANDS or no tobacco if LNC cigarettes were the only cigarettes available will be compared in arm 1 versus arm 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: Yes. Intend to share findings from this research through publications and presentations. Institutions and individuals wishing to access any resources or data must contact the Principal Investigator (Carroll). Data will be available in two formats. One will be a summary of the data, with graphs and tables, posted as pdf files and as raw individual-level data for analysis. Data generated by this grant will be made to outside investigators, according to NIH Guidance. When data are shared, there will be no limits placed on how the data will be used. Users will agree, however, that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. A record of transfer of data and a copy of the dataset that was distributed will be kept by University of Minnesota
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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 Mowls Carroll, Ph.D., M.P.H principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low Nicotine Content Cigarettes and Test message in people with Smoking and Cigarette, run by Masonic Cancer Center, University of Minnesota 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 3 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 26 Feb 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants that choose ANDS or no tobacco (time frame: Within 17 days of virtual screening). 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 26 Feb 2024.