Smoking BehaviorsNCT05108649
Impact of Nicotine Messaging on Beliefs and Behavior
A study testing Nicotine Messaging and Cigarette Condition in people with Smoking Behaviors and Cigarette Smoking, run by Andrew Strasser at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of nicotine messaging and nicotine content of study cigarettes on nicotine beliefs and subsequent use of tobacco and nicotine products. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Smoking Behaviors, Cigarette Smoking
- What is being tested?
- Nicotine Messaging and Cigarette Condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2022to 20 Jun 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-report smoking at least 5 non-menthol, filtered cigarettes per day for at least the last 12 months.
- Not currently undergoing smoking cessation treatment or planning to quit over the duration of the study (~6 weeks).
- Plan to live in the area for the duration of the study.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
- Able to communicate fluently in English (i.e., speaking, writing, and reading).
Who cannot join
- Smoke menthol cigarettes greater than 20% of the time.
- Smoke cigarettes of non-standard circumference (e.g., wides, slim, capri, etc.)
- Use of any nicotine containing products other than cigarettes. Participants reporting isolated use of other nicotine containing products less than 5 times per month are eligible to participate.
- Attempt to quit smoking over the duration of the study period.
- Provide a Carbon Monoxide (CO) reading less than 5 parts per million (ppm) at Session 1 (D0).
- History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. Attendance at alcoholics anonymous or narcotics anonymous meetings will not be considered medical treatment for the purposes of this protocol.
Show all 17Show fewer
- Current alcohol consumption that exceeds 25 standard drinks/week.
- Women, including all individuals assigned as "female" at birth, who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period.
- Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the proper completion of the study procedures. Notable impairments will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
- Color blindness.
- Serious or unstable medical condition. Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
- Lifetime history of schizophrenia, psychosis, and/or bipolar disorder.
- Current diagnosis of active major depression. Participants who maintain a diagnosis of major depression who have not experienced any major depressive episodes in the past 6 months and are stable on antidepressant medication(s) are eligible to participate.
- Additional, general reasons for exclusion include:
- Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator and/or Study Physician.
- Any circumstance, medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator and/or Study Physician. Participants may be withdrawn for any of the aforementioned reasons at any point throughout the study.
- Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Participants may be withdrawn at any point throughout the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interdisciplinary Research for Nicotine Addiction
Philadelphia, Pennsylvania, 19104
About this study
Official title: Study 2: Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior
The purpose of this study is to examine the effect of nicotine messaging and nicotine content of study cigarettes on nicotine beliefs and subsequent use of tobacco and nicotine products.
Read the detailed description
This project will utilize a randomized, factorial design trial to examine the effects of nicotine messaging on nicotine harm beliefs and smoking behavior. After a 7-day period of smoking own preferred brand cigarettes, participants will begin a 28-day experimental period and will be randomized to one of four conditions: 1) Nicotine Corrective Messaging (NCM) + Reduced nicotine content (RNC) cigarettes, 2) NCM + normal nicotine content (NNC) cigarettes, 3) Delayed Control Messaging + RNC cigarettes, or 4) Delayed Control Messaging + NNC cigarettes. The investigators will aim to recruit and randomize 160 current, daily cigarette smokers (80 male, 80 female) in a 35-day protocol. Participants will be asked to attend 6 in-person sessions at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) on Days 0, 7, 14, 21, 28 \& 35. Sessions will occur every 6-8 days.
- Conditions
- Smoking Behaviors, Cigarette Smoking
- Being tested
- Nicotine Messaging, Cigarette Condition
- Keywords
- Smoking Behavior
- Medical subject headings
- Smoking, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine MessagingOther
After completing a 7-day baseline period, participants will be randomized to a 28-day experimental period and will view nicotine corrective messaging at each in-person session or delayed control messaging at the final study session.
Cigarette ConditionOther
After completing a 7-day period of smoking own brand cigarettes, participants will be randomized to a 28-day experimental period and will receive reduced nicotine content (RNC) cigarettes or normal nicotine content (NNC) cigarettes.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Corrective Messaging | Experimental | After completing a 7-day baseline period, participants will be randomized to a 28-day experimental period and will view nicotine corrective messaging at each in-person session. Receives: Other: Nicotine Messaging |
| Delayed Control Messaging | Experimental | After completing a 7-day baseline period, participants will be randomized to a 28-day experimental period and will not view nicotine messaging until the final study session (Delayed Control Messaging). Receives: Other: Nicotine Messaging |
| Normal Nicotine Content (NNC) cigarettes | Experimental | After completing a 7-day baseline period of smoking own brand cigarettes, participants will be randomized to a 28-day experimental period and will receive normal nicotine content cigarettes. Receives: Other: Cigarette Condition |
| Reduced Nicotine Content (RNC) cigarettes | Experimental | After completing a 7-day baseline period of smoking own brand cigarettes, participants will be randomized to a 28-day experimental period and will receive reduced nicotine content cigarettes. Receives: Other: Cigarette Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine Beliefs
Nicotine belief measures will be assessed by participant self-report and comprised of four broad constructs (nicotine beliefs, NRT beliefs, e-cigarette beliefs, and RNC cigarette beliefs). Nicotine beliefs relate specifically to its addictive nature, nicotine as a cause of cancer, and the role of nicotine in the health harms and cancer caused by smoking. The product-specific constructs (i.e., NRT, e-cigarette, RNC cigarette) include items related to the addictiveness of the product and the perceived health risks of the product compared to regular cigarettes. Three items assessing nicotine false beliefs (range 3-11), 6 items assessing nicotine replacement therapy (NRT) false beliefs (range 4-20), 4 items assessing e-cigarette false beliefs (range 2-14), 11 items assessing reduced nicotine content (RNC) cigarettes false beliefs (range 14-45), and two items assessing beliefs about additive-free and organic tobacco products. Higher scale scores indicate a higher number of false beliefs.
Measured: Day 35
Secondary outcomes (6)
Daily Cigarette Consumption
Daily cigarette consumption will be assessed by participant self-report and verified through collection of spent filters.
Measured: Day 35
Puff Duration
Total puff duration, the sum of all puff durations per cigarette, will be collected using a standardized video scoring procedure. Participants will be video recorded while smoking each lab cigarette in order to collect smoking topography data.
Measured: Day 35
Carbon Monoxide (CO)
Carbon monoxide (CO; measured in parts per million [ppm]) is a measure of toxicant exposure. Two measures assess daily CO exposure (collected at the onset of each session) and CO boost - the change in CO values before and after smoking a cigarette - estimates smoke exposure due to smoking an individual cigarette.
Measured: Day 35
Number of Participants With Intention to Use Tobacco/Nicotine Products
Participants will provide subjective ratings for four items assessing intention to use tobacco cigarettes, e-cigarettes, NRT, and RNC cigarettes during the next 12 months. Adapted from PhenX Toolkit- Susceptibility to Tobacco Products, response options Definitely Yes; Probably Yes; Probably Not; Definitely Not. Outcomes reported for participants reporting Definitely Yes or Probably Yes to each item.
Measured: Day 35
Tobacco Use
Description Number of days used tobacco in the past 30 days. Days used summed across eight different nicotine/tobacco products (e.g., tobacco cigarettes, e-cigarettes, cigars, NRT, RNC cigarettes).
Measured: Day 35
Subjective Cigarette Ratings
Participants will provide subjective ratings of the strength and satisfaction for cigarettes smoked at Day 35 using a 100 mm Visual Analogue Scale (VAS). Anchors are item-specific (strength: 0 = "very weak," 100 = "very strong"), with lower scores indicating less favorable ratings.
Measured: Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start2 Mar 2022
- Primary completion20 Jun 2024
- Study completion20 Jun 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 Smoking BehaviorsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This project will recruit current, daily, non-menthol cigarette smokers to a 35-day, randomized, factorial design protocol. After a 7-day period of smoking own preferred brand cigarettes, participants will be randomized to a 28-day experimental period and will be randomized to one of four conditions: 1) Nicotine Corrective Messaging (NCM) + Reduced nicotine content (RNC) cigarettes, 2) NCM + normal nicotine content (NNC) cigarettes, 3) Delayed Control Messaging + RNC cigarettes, or 4) Delayed Control Messaging + NNC cigarettes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Strasser
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA), Rutgers University
- Responsible party
- Sponsor-investigator, Andrew Strasser, Abramson Cancer Center at Penn Medicine
- Investigators
- Andrew Strasser, Ph.D., Principal investigator, University of PennsylvaniaAndrea Villanti, Ph.D., Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108649
- Sponsor's protocol ID
- UPCC 06021
- Other IDs
- R01DA051001, 849654
- Status last verified
- Nov 2025
- First submitted
- 14 Oct 2021
- Last updated
- 8 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study 2: Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior
- ClinicalTrials.gov ID
- NCT05108649
- Acronym / sponsor ID
- UPCC 06021
- Conditions
- Smoking Behaviors, Cigarette Smoking
- Keywords
- Smoking Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Andrew StrasserUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA), Rutgers University
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Posted 8 Dec 2025
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 study is to examine the effect of nicotine messaging and nicotine content of study cigarettes on nicotine beliefs and subsequent use of tobacco and nicotine products.
Detailed description
This project will utilize a randomized, factorial design trial to examine the effects of nicotine messaging on nicotine harm beliefs and smoking behavior. After a 7-day period of smoking own preferred brand cigarettes, participants will begin a 28-day experimental period and will be randomized to one of four conditions: 1) Nicotine Corrective Messaging (NCM) + Reduced nicotine content (RNC) cigarettes, 2) NCM + normal nicotine content (NNC) cigarettes, 3) Delayed Control Messaging + RNC cigarettes, or 4) Delayed Control Messaging + NNC cigarettes. The investigators will aim to recruit and randomize 160 current, daily cigarette smokers (80 male, 80 female) in a 35-day protocol. Participants will be asked to attend 6 in-person sessions at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) on Days 0, 7, 14, 21, 28 \& 35. Sessions will occur every 6-8 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This project will recruit current, daily, non-menthol cigarette smokers to a 35-day, randomized, factorial design protocol. After a 7-day period of smoking own preferred brand cigarettes, participants will be randomized to a 28-day experimental period and will be randomized to one of four conditions: 1) Nicotine Corrective Messaging (NCM) + Reduced nicotine content (RNC) cigarettes, 2) NCM + normal nicotine content (NNC) cigarettes, 3) Delayed Control Messaging + RNC cigarettes, or 4) Delayed Control Messaging + NNC cigarettes.
| Arm | Type | Receives |
|---|---|---|
| Nicotine Corrective Messaging | Experimental | Other: Nicotine MessagingAfter completing a 7-day baseline period, participants will be randomized to a 28-day experimental period and will view nicotine corrective messaging at each in-person session. |
| Delayed Control Messaging | Experimental | Other: Nicotine MessagingAfter completing a 7-day baseline period, participants will be randomized to a 28-day experimental period and will not view nicotine messaging until the final study session (Delayed Control Messaging). |
| Normal Nicotine Content (NNC) cigarettes | Experimental | Other: Cigarette ConditionAfter completing a 7-day baseline period of smoking own brand cigarettes, participants will be randomized to a 28-day experimental period and will receive normal nicotine content cigarettes. |
| Reduced Nicotine Content (RNC) cigarettes | Experimental | Other: Cigarette ConditionAfter completing a 7-day baseline period of smoking own brand cigarettes, participants will be randomized to a 28-day experimental period and will receive reduced nicotine content cigarettes. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-report smoking at least 5 non-menthol, filtered cigarettes per day for at least the last 12 months.
- Not currently undergoing smoking cessation treatment or planning to quit over the duration of the study (~6 weeks).
- Plan to live in the area for the duration of the study.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
- Able to communicate fluently in English (i.e., speaking, writing, and reading).
Key exclusion criteria (17 listed)
- Smoke menthol cigarettes greater than 20% of the time.
- Smoke cigarettes of non-standard circumference (e.g., wides, slim, capri, etc.)
- Use of any nicotine containing products other than cigarettes. Participants reporting isolated use of other nicotine containing products less than 5 times per month are eligible to participate.
- Attempt to quit smoking over the duration of the study period.
- Provide a Carbon Monoxide (CO) reading less than 5 parts per million (ppm) at Session 1 (D0).
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 |
|---|---|---|
| Nicotine MessagingAfter completing a 7-day baseline period, participants will be randomized to a 28-day experimental period and will view nicotine corrective messaging at each in-person session or delayed control messaging at the final study session. | Other | Delayed Control Messaging, Nicotine Corrective Messaging |
| Cigarette ConditionAfter completing a 7-day period of smoking own brand cigarettes, participants will be randomized to a 28-day experimental period and will receive reduced nicotine content (RNC) cigarettes or normal nicotine content (NNC) cigarettes. | Other | Normal Nicotine Content (NNC) cigarettes, Reduced Nicotine Content (RNC) cigarettes |
Primary outcome
Nicotine Beliefs
Time frame: Day 35
Nicotine belief measures will be assessed by participant self-report and comprised of four broad constructs (nicotine beliefs, NRT beliefs, e-cigarette beliefs, and RNC cigarette beliefs). Nicotine beliefs relate specifically to its addictive nature, nicotine as a cause of cancer, and the role of nicotine in the health harms and cancer caused by smoking. The product-specific constructs (i.e., NRT, e-cigarette, RNC cigarette) include items related to the addictiveness of the product and the perceived health risks of the product compared to regular cigarettes. Three items assessing nicotine false beliefs (range 3-11), 6 items assessing nicotine replacement therapy (NRT) false beliefs (range 4-20), 4 items assessing e-cigarette false beliefs (range 2-14), 11 items assessing reduced nicotine content (RNC) cigarettes false beliefs (range 14-45), and two items assessing beliefs about additive-free and organic tobacco products. Higher scale scores indicate a higher number of false beliefs.
6 secondary outcomes
Daily Cigarette Consumption
Time frame: Day 35
Puff Duration
Time frame: Day 35
Carbon Monoxide (CO)
Time frame: Day 35
Number of Participants With Intention to Use Tobacco/Nicotine Products
Time frame: Day 35
Tobacco Use
Time frame: Day 35
Subjective Cigarette Ratings
Time frame: Day 35
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrew Strasser, Ph.D. principal investigator
University of Pennsylvania
Andrea Villanti, Ph.D. principal investigator
Rutgers 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 Nicotine Messaging and Cigarette Condition in people with Smoking Behaviors and Cigarette Smoking, run by Andrew Strasser 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 5 inclusion and 17 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 Dec 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 Dec 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?
Nicotine Beliefs (time frame: Day 35). 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 8 Dec 2025.