Smoking, CigaretteCENIC2-P3NCT03194256
Evaluating New Nicotine Standards for Cigarettes - Project 3
A study testing Spectrum Research Cigarettes in people with Smoking, Cigarette and Electronic Cigarettes, run by Brown University at 1 site in United States.
Trial summary
This study is designed to examine how the nicotine content of cigarettes and the nicotine concentration and flavors in e-liquids influence responses to and use of these products in adolescent smokers. Participants will complete a total of six sessions (an in-person screening/baseline session and five lab sessions. Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigarette, Electronic Cigarettes
- What is being tested?
- Spectrum Research Cigarettes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 30 Nov 2022
- 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 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages 15-20
- Adolescents who report current daily or near daily cigarette smoking for at least 3 months
- Must have used an electronic nicotine device on a minimum of two lifetime occasions.
- Breath Carbon Monoxide (CO) levels > 5 ppm (if < 5 ppm, then cotinine assay via NicAlert Strip = > 3)
- Speak, comprehend, and read English well enough to complete study procedures
Who cannot join
- Unwilling to use research cigarettes or ENDS as part of the study
- Intention to quit smoking in the next 30 days
- Using tobacco products (other than ENDS or roll-your-own tobacco) > 15 days in the past 30 days.
- Any medical or psychiatric condition in which participation is likely to post a significant threat to health or for which the condition could interfere with the ability of the participant to fully participants (as determined by the LMP)
- Self-reported illicit use of any drug except marijuana > 10 days in the past 30 days
- Binge drinking alcohol (>10 days in the past 30 days, >4/5 drinks in a 2-hour period (female/male))
Show all 11Show fewer
- Pregnant or breastfeeding
- CO reading > 80 ppm
- Systolic BP outside the range of 90-159, diastolic BP outside the range of 50-99, or heart rate outside the range of 45-104. Participants failing for any of these criteria will be allowed to re-screen once per criterion.
- Indicating Yes on Questions 4-6 on the MINI with a suicide attempt in the past 2 years (if within the past 2-10 years, LMP approval required).
- Having participated in another research study during the past year in which they were switched to reduced nicotine cigarettes for longer than one week.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University School of Public Health
Providence, Rhode Island, 02912
About this study
Official title: Effects of Very Low Nicotine Content Cigarettes and E-cigarette Characteristics on Smoking in Adolescents
This study is designed to examine how the nicotine content of cigarettes and the nicotine concentration and flavors in e-liquids influence responses to and use of these products in adolescent smokers. Participants will complete a total of six sessions (an in-person screening/baseline session and five lab sessions.
Read the detailed description
Adolescence is a critical developmental period for tobacco initiation and progression to regular use and dependence. The Food and Drug Administration (FDA) has the authority to establish standards for tobacco products for the protection of public health, including the authority to mandate a reduction in the nicotine content of all cigarettes to minimally addictive levels. Numerous studies have found that adult smokers who are switched to very low nicotine content (VLNC) cigarettes experience reductions in smoking rates, nicotine intake, nicotine dependence and abstinence-induced craving relative to those who use normal nicotine content (NNC) cigarettes. However, studies of VLNC cigarettes in adolescent smokers are limited and more information is needed to inform potential product standards. Furthermore, use of electronic nicotine delivery systems (ENDS), e-cigarettes or vaping devices, has increased dramatically in adolescents. Therefore, effects of VLNC cigarettes on smoking in youth should be examined in the context of vaping device availability. This study is designed to examine how the nicotine content of cigarettes and the nicotine concentration and flavors in e-liquids influence responses to these products in adolescents.
Participants will complete an in-person baseline session in which eligibility criteria are confirmed and background questionnaires are completed. Next, participants will complete five in-person lab sessions in which NNC or VLNC cigarettes are available (based on random assignment). During the first lab session, participants will test the assigned research cigarettes when no alternative product is available. During each of the four remaining lab sessions, smokers' responses to the assigned research cigarettes will be compared to their responses to a vaping device with the following characteristics: 1) no nicotine, tobacco flavor; 2) no nicotine, non-tobacco flavor; 3) moderate nicotine concentration, tobacco flavor; or 4) moderate nicotine concentration, non-tobacco flavor. In each session, after sampling and rating the subjective effects of the products available during that session, participants will make a series of 10 choices. Choices will be for either 2 puffs of the research cigarette, 2 puffs of the vaping device, or abstinence from puffing.
- Conditions
- Smoking, Cigarette, Electronic Cigarettes
- Being tested
- Spectrum Research Cigarettes
- Keywords
- Smoking, Cigarettes, E-Cigarettes
- Medical subject headings
- Cigarette Smoking, Vaping, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectrum Research CigarettesBehavioural
Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
| Study group | Role | What they receive |
|---|---|---|
| Normal Nicotine Content Cigarettes | Active comparator | Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar Receives: Behavioral: Spectrum Research Cigarettes |
| Very Low Nicotine Content Cigarettes | Experimental | Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar Receives: Behavioral: Spectrum Research Cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cigarette Puffs Taken (0 to 20)
The number of cigarette puffs selected during a 30 minute choice procedure when no vaping device was available
Measured: 30-minute preference task
Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 3mg/ml of Nicotine and Was Available in Tobacco Flavor
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 3mg/ml of nicotine and was available in tobacco flavor
Measured: 30-minute preference task
Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 3mg/ml of Nicotine and Was Available in Non-tobacco Flavors
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 3mg/ml of nicotine and was available in non-tobacco flavors
Measured: 30-minute preference task
Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 18mg/ml of Nicotine and Was Available in Tobacco Flavor
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 18mg/ml of nicotine and was available in tobacco flavor
Measured: 30-minute preference task
Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 18mg/ml of Nicotine and Was Available in Non-tobacco Flavors
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 18mg/ml of nicotine and was available in non-tobacco flavors
Measured: 30-minute preference task
Secondary outcomes (9)
Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Tobacco Flavor
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device contained 3mg/ml nicotine and was available in tobacco flavor
Measured: 30-minute preference task session
Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Non-tobacco Flavors
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device contained 3mg/ml nicotine and was available in non-tobacco flavors
Measured: 30-minute preference task session
Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Tobacco Flavor
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device contained 18mg/ml nicotine and was available in tobacco flavor
Measured: 30-minute preference task session
Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Non-tobacco Flavors
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device contained 18mg/ml nicotine and was available in non-tobacco flavors
Measured: 30-minute preference task session
Carbon Monoxide Change From pre-to the Post-choice Task When no Vaping Device Was Available
Post-choice CO minus pre-choice CO at session 1 in which no vaping device was available
Measured: 30-minute preference task
Carbon Monoxide Change From pre-to the Post-choice Task When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Tobacco Flavor
Post-choice CO minus pre-choice CO when the available vaping device contained 3mg/ml nicotine and was available in tobacco flavor
Measured: 30-minute preference task
Carbon Monoxide Change From pre-to the Post-choice Taskwhen the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Non-tobacco Flavors
Post-choice CO minus pre-choice CO when the available vaping device contained 3mg/ml nicotine and was available in non-tobacco flavors
Measured: 30-minute preference task
Carbon Monoxide Change From pre-to the Post-choice Task When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Tobacco Flavor
Post-choice CO minus pre-choice CO when the available vaping device contained 18mg/ml nicotine and was available in tobacco flavor
Measured: 30-minute preference task
Carbon Monoxide Change From pre-to the Post-choice Task When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Non-tobacco Flavors
Post-choice CO minus pre-choice CO when the available vaping device contained 18mg/ml nicotine and was available in non-tobacco flavors
Measured: 30-minute preference task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Sep 2018
- Primary completion28 Oct 2022
- Study completion30 Nov 2022
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, CigaretteStudies 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
- Parallel groups
- Model description
- Mixed between subjects and within-subjects design. Random assignment to the between subjects factor (nicotine content in cigarettes), within-subjects manipulation of nicotine concentration and flavors in e-liquid in the electronic cigarettes
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University, University of Minnesota, National Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Suzanne Colby, PhD, Principal investigator, Brown UniversityJennifer Tidey, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194256
- Sponsor's protocol ID
- 1705001771
- Other IDs
- U54DA031659
- Acronym
- CENIC2-P3
- Status last verified
- Nov 2023
- First submitted
- 7 Jun 2017
- Last updated
- 18 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- 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 (Hatsukami). 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 Brown University.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Very Low Nicotine Content Cigarettes and E-cigarette Characteristics on Smoking in Adolescents
- ClinicalTrials.gov ID
- NCT03194256
- Acronym / sponsor ID
- CENIC2-P3 / 1705001771
- Conditions
- Smoking, Cigarette, Electronic Cigarettes
- Keywords
- Smoking, Cigarettes, E-Cigarettes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Wake Forest University, University of Minnesota, National Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Posted 18 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to examine how the nicotine content of cigarettes and the nicotine concentration and flavors in e-liquids influence responses to and use of these products in adolescent smokers. Participants will complete a total of six sessions (an in-person screening/baseline session and five lab sessions.
Detailed description
Adolescence is a critical developmental period for tobacco initiation and progression to regular use and dependence. The Food and Drug Administration (FDA) has the authority to establish standards for tobacco products for the protection of public health, including the authority to mandate a reduction in the nicotine content of all cigarettes to minimally addictive levels. Numerous studies have found that adult smokers who are switched to very low nicotine content (VLNC) cigarettes experience reductions in smoking rates, nicotine intake, nicotine dependence and abstinence-induced craving relative to those who use normal nicotine content (NNC) cigarettes. However, studies of VLNC cigarettes in adolescent smokers are limited and more information is needed to inform potential product standards. Furthermore, use of electronic nicotine delivery systems (ENDS), e-cigarettes or vaping devices, has increased dramatically in adolescents. Therefore, effects of VLNC cigarettes on smoking in youth should be examined in the context of vaping device availability. This study is designed to examine how the nicotine content of cigarettes and the nicotine concentration and flavors in e-liquids influence responses to these products in adolescents.
Participants will complete an in-person baseline session in which eligibility criteria are confirmed and background questionnaires are completed. Next, participants will complete five in-person lab sessions in which NNC or VLNC cigarettes are available (based on random assignment). During the first lab session, participants will test the assigned research cigarettes when no alternative product is available. During each of the four remaining lab sessions, smokers' responses to the assigned research cigarettes will be compared to their responses to a vaping device with the following characteristics: 1) no nicotine, tobacco flavor; 2) no nicotine, non-tobacco flavor; 3) moderate nicotine concentration, tobacco flavor; or 4) moderate nicotine concentration, non-tobacco flavor. In each session, after sampling and rating the subjective effects of the products available during that session, participants will make a series of 10 choices. Choices will be for either 2 puffs of the research cigarette, 2 puffs of the vaping device, or abstinence from puffing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Mixed between subjects and within-subjects design. Random assignment to the between subjects factor (nicotine content in cigarettes), within-subjects manipulation of nicotine concentration and flavors in e-liquid in the electronic cigarettes
| Arm | Type | Receives |
|---|---|---|
| Normal Nicotine Content Cigarettes | Active comparator | Behavioral: Spectrum Research CigarettesSpectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar |
| Very Low Nicotine Content Cigarettes | Experimental | Behavioral: Spectrum Research CigarettesSpectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Ages 15-20
- Adolescents who report current daily or near daily cigarette smoking for at least 3 months
- Must have used an electronic nicotine device on a minimum of two lifetime occasions.
- Breath Carbon Monoxide (CO) levels > 5 ppm (if < 5 ppm, then cotinine assay via NicAlert Strip = > 3)
- Speak, comprehend, and read English well enough to complete study procedures
Key exclusion criteria (11 listed)
- Unwilling to use research cigarettes or ENDS as part of the study
- Intention to quit smoking in the next 30 days
- Using tobacco products (other than ENDS or roll-your-own tobacco) > 15 days in the past 30 days.
- Any medical or psychiatric condition in which participation is likely to post a significant threat to health or for which the condition could interfere with the ability of the participant to fully participants (as determined by the LMP)
- Self-reported illicit use of any drug except marijuana > 10 days in the past 30 days
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 |
|---|---|---|
| Spectrum Research CigarettesParticipants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes. | Behavioural | Normal Nicotine Content Cigarettes, Very Low Nicotine Content Cigarettes |
Primary outcome
Number of Cigarette Puffs Taken (0 to 20)
Time frame: 30-minute preference task
The number of cigarette puffs selected during a 30 minute choice procedure when no vaping device was available
Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 3mg/ml of Nicotine and Was Available in Tobacco Flavor
Time frame: 30-minute preference task
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 3mg/ml of nicotine and was available in tobacco flavor
Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 3mg/ml of Nicotine and Was Available in Non-tobacco Flavors
Time frame: 30-minute preference task
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 3mg/ml of nicotine and was available in non-tobacco flavors
Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 18mg/ml of Nicotine and Was Available in Tobacco Flavor
Time frame: 30-minute preference task
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 18mg/ml of nicotine and was available in tobacco flavor
Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 18mg/ml of Nicotine and Was Available in Non-tobacco Flavors
Time frame: 30-minute preference task
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 18mg/ml of nicotine and was available in non-tobacco flavors
9 secondary outcomes
Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Tobacco Flavor
Time frame: 30-minute preference task session
Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Non-tobacco Flavors
Time frame: 30-minute preference task session
Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Tobacco Flavor
Time frame: 30-minute preference task session
Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Non-tobacco Flavors
Time frame: 30-minute preference task session
Carbon Monoxide Change From pre-to the Post-choice Task When no Vaping Device Was Available
Time frame: 30-minute preference task
Carbon Monoxide Change From pre-to the Post-choice Task When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Tobacco Flavor
Time frame: 30-minute preference task
Carbon Monoxide Change From pre-to the Post-choice Taskwhen the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Non-tobacco Flavors
Time frame: 30-minute preference task
Carbon Monoxide Change From pre-to the Post-choice Task When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Tobacco Flavor
Time frame: 30-minute preference task
Carbon Monoxide Change From pre-to the Post-choice Task When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Non-tobacco Flavors
Time frame: 30-minute preference task
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 (Hatsukami). 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 Brown University.
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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.
Suzanne Colby, PhD principal investigator
Brown University
Jennifer Tidey, PhD principal investigator
Brown 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 Spectrum Research Cigarettes in people with Smoking, Cigarette and Electronic Cigarettes, run by Brown University 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 11 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 18 Dec 2023. 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 18 Dec 2023). 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?
Number of Cigarette Puffs Taken (0 to 20) (time frame: 30-minute preference task). The study lists 5 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 18 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.