SmokingNCT03185546

Project 2 Cigarette and E-cigarette Nicotine Content and E-liquid Flavors

A study testing NNC Spectrum Cigarette, VLNC Spectrum Cigarette and Moderate nicotine level e-liquid in people with Smoking, run by Wake Forest University Health Sciences at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Smoking
What is being tested?: NNC Spectrum Cigarette, VLNC Spectrum Cigarette and Moderate nicotine level e-liquid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 156 participants
Where: 2 sitesUnited States
Study dates: 6 Aug 2018to 13 Mar 2020
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Smokers who have tried vaping multiple times.
Generally good health.

Who cannot join

If female, currently pregnant, trying to become pregnant or breastfeeding.
Planning to quit smoking.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Wake Forest Biotech Place
Winston-Salem, North Carolina, 27101

Other trials in United States

About this study

Official title: Project 2: The Impact of Cigarette Nicotine Content, E-cigarette Nicotine Content, and E-cigarette Flavoring on Smoking Behavior

Project 2 will evaluate the impact of very low nicotine content cigarettes, e-cigarette nicotine content, and e-cigarette flavoring on cigarettes smoked per day, nicotine exposure, puff topography, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cardiovascular function, and perceived risk. Project 2 will also evaluate differences between conditions in compliance with product use and the ability to abstain from cigarette smoking when provided a financial incentive for abstinence from combusted tobacco. This is not a treatment program for smoking.

Conditions: Smoking
Being tested: NNC Spectrum Cigarette, VLNC Spectrum Cigarette, Moderate nicotine level e-liquid, Low nicotine level e-liquid, Tobacco Flavors
Keywords: smoking, vaping
Medical subject headings: Smoking, Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NNC Spectrum CigaretteOther
Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
VLNC Spectrum CigaretteOther
Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquidOther
Participants are provided with moderate nicotine level e-liquid for 13 weeks
Low nicotine level e-liquidOther
Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco FlavorsOther
Participants can choose e-liquid flavors from a selection of tobacco flavors
Tobacco and non-tobacco e-liquid flavorsOther
Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices

Study groups in NCT03185546
Study group	Role	What they receive
Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors	Experimental	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. Receives: Other: NNC Spectrum Cigarette; Other: Moderate nicotine level e-liquid; Other: Tobacco Flavors
NNC cigarette + low nicotine e-liquid + tobacco flavors	Experimental	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. Receives: Other: NNC Spectrum Cigarette; Other: Low nicotine level e-liquid; Other: Tobacco Flavors
NNC cigarette + moderate nicotine e-liquid + variety flavors	Experimental	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors. Receives: Other: NNC Spectrum Cigarette; Other: Moderate nicotine level e-liquid; Other: Tobacco and non-tobacco e-liquid flavors
NNC cigarette + low nicotine e-liquid + variety flavors	Experimental	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors Receives: Other: NNC Spectrum Cigarette; Other: Low nicotine level e-liquid; Other: Tobacco and non-tobacco e-liquid flavors
Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor	Experimental	Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. Receives: Other: VLNC Spectrum Cigarette; Other: Moderate nicotine level e-liquid; Other: Tobacco Flavors
VLNC cigarette + low nicotine e-liquid +tobacco flavors	Experimental	Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. Receives: Other: VLNC Spectrum Cigarette; Other: Low nicotine level e-liquid; Other: Tobacco Flavors
VLNC cigarette + moderate nicotine e-liquid + variety flavors	Experimental	Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors. Receives: Other: VLNC Spectrum Cigarette; Other: Moderate nicotine level e-liquid; Other: Tobacco and non-tobacco e-liquid flavors
VLNC cigarette + low nicotine e-liquid + variety flavors	Experimental	Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors Receives: Other: VLNC Spectrum Cigarette; Other: Low nicotine level e-liquid; Other: Tobacco and non-tobacco e-liquid flavors

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Cigarettes Smoked Per Day
The average number of cigarettes (study and non-study, summed) smoked per day between the Week 10 and Week 12 visits (the end of the study).
Measured: Week 10 through Week 12

Secondary outcomes (2)

Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO)
Measure of cigarette smoke exposure using data on expired breath CO. CO was captured using Covita Smokelyzer devices and standard exhalation procedures. The unit of measurement is parts per million (ppm).
Measured: Baseline - Week 12
Number of Subjects With Smoke Free Days
Study team generates the smoke free days outcome by counting days where no cigarettes and no other forms of combusted tobacco products are used. Days where participants use no nicotine products and days where participants only vape are "smoke free." Percentage of smoke free days = the number days that participants reported smoking 0 cigarettes (0 study cigarettes and 0 non-study cigarettes) divided by the total number of days between their randomization and Week 12 visits. Due to the distribution of the data, statisticians grouped participants according to whether they had 0 smoke-free days or more than 0 smoke free days during the study.
Measured: Baseline-Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Aug 201813 Mar 2020

First posted14 Jun 2017
Study start6 Aug 2018
Primary completion13 Mar 2020
Study completion13 Mar 2020

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 (26)Papers the sponsor has linked to this study.
Other trials for SmokingStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03185546
Sponsor's protocol ID: IRB00047676
Other IDs: 1U54DA031659-01, U54DA031659-06
Status last verified: Apr 2021
First submitted: 22 May 2017
Last updated: 14 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data will be available to other researchers, please contact the principal investigator for instructions.

Publications

Agaku IT, King BA, Husten CG, Bunnell R, Ambrose BK, Hu SS, Holder-Hayes E, Day HR; Centers for Disease Control and Prevention (CDC). Tobacco product use among adults--United States, 2012-2013. MMWR Morb Mortal Wkly Rep. 2014 Jun 27;63(25):542-7.
PubMed 24964880
Arrazola RA, Singh T, Corey CG, Husten CG, Neff LJ, Apelberg BJ, Bunnell RE, Choiniere CJ, King BA, Cox S, McAfee T, Caraballo RS; Centers for Disease Control and Prevention (CDC). Tobacco use among middle and high school students - United States, 2011-2014. MMWR Morb Mortal Wkly Rep. 2015 Apr 17;64(14):381-5.
PubMed 25879896
Baker H. E-cigarettes and subsequent tobacco use in adolescence. Lancet Oncol. 2015 Oct;16(13):e481. doi: 10.1016/S1470-2045(15)00272-7. Epub 2015 Aug 28. No abstract available.
PubMed 26321209
Bandiera FC, Ross KC, Taghavi S, Delucchi K, Tyndale RF, Benowitz NL. Nicotine Dependence, Nicotine Metabolism, and the Extent of Compensation in Response to Reduced Nicotine Content Cigarettes. Nicotine Tob Res. 2015 Sep;17(9):1167-72. doi: 10.1093/ntr/ntu337. Epub 2015 Jan 2.
PubMed 25555385
BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369
Biener L, Abrams DB. The Contemplation Ladder: validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10(5):360-5. doi: 10.1037//0278-6133.10.5.360.
PubMed 1935872
Benowitz NL, Pomerleau OF, Pomerleau CS, Jacob P 3rd. Nicotine metabolite ratio as a predictor of cigarette consumption. Nicotine Tob Res. 2003 Oct;5(5):621-4. doi: 10.1080/1462220031000158717.
PubMed 14577978
Benowitz NL, Henningfield JE. Establishing a nicotine threshold for addiction. The implications for tobacco regulation. N Engl J Med. 1994 Jul 14;331(2):123-5. doi: 10.1056/NEJM199407143310212. No abstract available.
PubMed 7818638
Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Progressive commercial cigarette yield reduction: biochemical exposure and behavioral assessment. Cancer Epidemiol Biomarkers Prev. 2009 Mar;18(3):876-83. doi: 10.1158/1055-9965.EPI-08-0731. Epub 2009 Mar 3.
PubMed 19258480
Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Smoking behavior and exposure to tobacco toxicants during 6 months of smoking progressively reduced nicotine content cigarettes. Cancer Epidemiol Biomarkers Prev. 2012 May;21(5):761-9. doi: 10.1158/1055-9965.EPI-11-0644. Epub 2012 Feb 21.
PubMed 22354905
Benowitz NL, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Nicotine and carcinogen exposure with smoking of progressively reduced nicotine content cigarette. Cancer Epidemiol Biomarkers Prev. 2007 Nov;16(11):2479-85. doi: 10.1158/1055-9965.EPI-07-0393.
PubMed 18006940
Benowitz NL, Nardone N, Dains KM, Hall SM, Stewart S, Dempsey D, Jacob P 3rd. Effect of reducing the nicotine content of cigarettes on cigarette smoking behavior and tobacco smoke toxicant exposure: 2-year follow up. Addiction. 2015 Oct;110(10):1667-75. doi: 10.1111/add.12978. Epub 2015 Jul 21.
PubMed 26198394
Blank MD, Disharoon S, Eissenberg T. Comparison of methods for measurement of smoking behavior: mouthpiece-based computerized devices versus direct observation. Nicotine Tob Res. 2009 Jul;11(7):896-903. doi: 10.1093/ntr/ntp083. Epub 2009 Jun 11.
PubMed 19525207
Brauer LH, Hatsukami D, Hanson K, Shiffman S. Smoking topography in tobacco chippers and dependent smokers. Addict Behav. 1996 Mar-Apr;21(2):233-8. doi: 10.1016/0306-4603(95)00054-2.
PubMed 8730526
Buchhalter AR, Acosta MC, Evans SE, Breland AB, Eissenberg T. Tobacco abstinence symptom suppression: the role played by the smoking-related stimuli that are delivered by denicotinized cigarettes. Addiction. 2005 Apr;100(4):550-9. doi: 10.1111/j.1360-0443.2005.01030.x.
PubMed 15784070

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Smoking trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Project 2: The Impact of Cigarette Nicotine Content, E-cigarette Nicotine Content, and E-cigarette Flavoring on Smoking Behavior
ClinicalTrials.gov ID: NCT03185546
Acronym / sponsor ID: IRB00047676
Conditions: Smoking
Keywords: smoking, vaping
Study type: Interventional
Recruitment status: Completed
Enrolment: 156 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: University of Pennsylvania, National Institute on Drug Abuse (NIDA)
Study start: 6 Aug 2018 (actual)
Primary completion: 13 Mar 2020 (actual)
Study completion: 13 Mar 2020 (actual)
First posted: 14 Jun 2017 (actual)
Results: Posted 14 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors	Experimental	Other: NNC Spectrum Cigarette, Other: Moderate nicotine level e-liquid, Other: Tobacco FlavorsParticipants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC cigarette + low nicotine e-liquid + tobacco flavors	Experimental	Other: NNC Spectrum Cigarette, Other: Low nicotine level e-liquid, Other: Tobacco FlavorsParticipants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC cigarette + moderate nicotine e-liquid + variety flavors	Experimental	Other: NNC Spectrum Cigarette, Other: Moderate nicotine level e-liquid, Other: Tobacco and non-tobacco e-liquid flavorsParticipants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
NNC cigarette + low nicotine e-liquid + variety flavors	Experimental	Other: NNC Spectrum Cigarette, Other: Low nicotine level e-liquid, Other: Tobacco and non-tobacco e-liquid flavorsParticipants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor	Experimental	Other: VLNC Spectrum Cigarette, Other: Moderate nicotine level e-liquid, Other: Tobacco FlavorsParticipants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC cigarette + low nicotine e-liquid +tobacco flavors	Experimental	Other: VLNC Spectrum Cigarette, Other: Low nicotine level e-liquid, Other: Tobacco FlavorsParticipants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC cigarette + moderate nicotine e-liquid + variety flavors	Experimental	Other: VLNC Spectrum Cigarette, Other: Moderate nicotine level e-liquid, Other: Tobacco and non-tobacco e-liquid flavorsParticipants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
VLNC cigarette + low nicotine e-liquid + variety flavors	Experimental	Other: VLNC Spectrum Cigarette, Other: Low nicotine level e-liquid, Other: Tobacco and non-tobacco e-liquid flavorsParticipants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Smokers who have tried vaping multiple times.
Generally good health.

Key exclusion criteria (2 listed)

If female, currently pregnant, trying to become pregnant or breastfeeding.
Planning to quit smoking.

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
NNC Spectrum CigaretteParticipants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.	Other	NNC cigarette + low nicotine e-liquid + tobacco flavors, NNC cigarette + low nicotine e-liquid + variety flavors, NNC cigarette + moderate nicotine e-liquid + variety flavors, Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors
VLNC Spectrum CigaretteParticipants are provided with very low nicotine content Spectrum Cigarette for13 weeks	Other	VLNC cigarette + low nicotine e-liquid + variety flavors, VLNC cigarette + low nicotine e-liquid +tobacco flavors, VLNC cigarette + moderate nicotine e-liquid + variety flavors, Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor
Moderate nicotine level e-liquidParticipants are provided with moderate nicotine level e-liquid for 13 weeks	Other	NNC cigarette + moderate nicotine e-liquid + variety flavors, Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors, VLNC cigarette + moderate nicotine e-liquid + variety flavors, Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor
Low nicotine level e-liquidParticipants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks	Other	NNC cigarette + low nicotine e-liquid + tobacco flavors, NNC cigarette + low nicotine e-liquid + variety flavors, VLNC cigarette + low nicotine e-liquid + variety flavors, VLNC cigarette + low nicotine e-liquid +tobacco flavors
Tobacco FlavorsParticipants can choose e-liquid flavors from a selection of tobacco flavors	Other	NNC cigarette + low nicotine e-liquid + tobacco flavors, Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors, VLNC cigarette + low nicotine e-liquid +tobacco flavors, Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor
Tobacco and non-tobacco e-liquid flavorsParticipants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices	Other	NNC cigarette + low nicotine e-liquid + variety flavors, NNC cigarette + moderate nicotine e-liquid + variety flavors, VLNC cigarette + low nicotine e-liquid + variety flavors, VLNC cigarette + moderate nicotine e-liquid + variety flavors

Primary outcome

Total Cigarettes Smoked Per Day
Time frame: Week 10 through Week 12
The average number of cigarettes (study and non-study, summed) smoked per day between the Week 10 and Week 12 visits (the end of the study).

2 secondary outcomes

Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO)
Time frame: Baseline - Week 12
Number of Subjects With Smoke Free Days
Time frame: Baseline-Week 12

Results and safety

Results posted to the registry on 14 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Nicotine Content (NNC) Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors	6	2
NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors	10	7
NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors	5	4
NNC Cigarette + Low Nicotine E-liquid + Variety Flavors	5	4
Very Low Nicotine Content (VLNC) Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor	6	5
VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors	6	4
VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors	7	4
VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors	5	2

Primary outcome: Total Cigarettes Smoked Per Day

Time frame: Week 10 through Week 12. Mean (Standard Deviation). Unit: number of cigarettes

Measure	NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors n = 2	VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors n = 4	VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors n = 4	VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor n = 5	NNC Cigarette + Low Nicotine E-liquid + Variety Flavors n = 4	NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors n = 4	NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors n = 7	VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors n = 2
Value	21.6 (3.7)	7.7 (12.1)	18.4 (8)	12.5 (16.3)	34 (14.8)	18.7 (13.9)	17.7 (8.5)	15.8 (1.1)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors	0 of 6 (0%)	6 of 6 (100%)	0 of 6
VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor	0 of 6 (0%)	6 of 6 (100%)	0 of 6
NNC Cigarette + Low Nicotine E-liquid + Variety Flavors	0 of 5 (0%)	5 of 5 (100%)	0 of 5
NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors	1 of 5 (20%)	4 of 5 (80%)	0 of 5
NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors	1 of 10 (10%)	10 of 10 (100%)	0 of 10
VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Pre-Randomization	0 of 106 (0%)	14 of 106 (13.2%)	0 of 106

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24964880Agaku IT, King BA, Husten CG, Bunnell R, Ambrose BK, Hu SS, Holder-Hayes E, Day HR; Centers for Disease Control and Prevention (CDC). Tobacco product use among adults--United States, 2012-2013. MMWR Morb Mortal Wkly Rep. 2014 Jun 27;63(25):542-7.
Background: PubMed 25879896Arrazola RA, Singh T, Corey CG, Husten CG, Neff LJ, Apelberg BJ, Bunnell RE, Choiniere CJ, King BA, Cox S, McAfee T, Caraballo RS; Centers for Disease Control and Prevention (CDC). Tobacco use among middle and high school students - United States, 2011-2014. MMWR Morb Mortal Wkly Rep. 2015 Apr 17;64(14):381-5.
Background: PubMed 26321209Baker H. E-cigarettes and subsequent tobacco use in adolescence. Lancet Oncol. 2015 Oct;16(13):e481. doi: 10.1016/S1470-2045(15)00272-7. Epub 2015 Aug 28. No abstract available.
Background: PubMed 25555385Bandiera FC, Ross KC, Taghavi S, Delucchi K, Tyndale RF, Benowitz NL. Nicotine Dependence, Nicotine Metabolism, and the Extent of Compensation in Response to Reduced Nicotine Content Cigarettes. Nicotine Tob Res. 2015 Sep;17(9):1167-72. doi: 10.1093/ntr/ntu337. Epub 2015 Jan 2.
Background: PubMed 13688369BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
Background: PubMed 1935872Biener L, Abrams DB. The Contemplation Ladder: validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10(5):360-5. doi: 10.1037//0278-6133.10.5.360.
Background: PubMed 14577978Benowitz NL, Pomerleau OF, Pomerleau CS, Jacob P 3rd. Nicotine metabolite ratio as a predictor of cigarette consumption. Nicotine Tob Res. 2003 Oct;5(5):621-4. doi: 10.1080/1462220031000158717.
Background: PubMed 7818638Benowitz NL, Henningfield JE. Establishing a nicotine threshold for addiction. The implications for tobacco regulation. N Engl J Med. 1994 Jul 14;331(2):123-5. doi: 10.1056/NEJM199407143310212. No abstract available.
Background: PubMed 19258480Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Progressive commercial cigarette yield reduction: biochemical exposure and behavioral assessment. Cancer Epidemiol Biomarkers Prev. 2009 Mar;18(3):876-83. doi: 10.1158/1055-9965.EPI-08-0731. Epub 2009 Mar 3.
Background: PubMed 22354905Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Smoking behavior and exposure to tobacco toxicants during 6 months of smoking progressively reduced nicotine content cigarettes. Cancer Epidemiol Biomarkers Prev. 2012 May;21(5):761-9. doi: 10.1158/1055-9965.EPI-11-0644. Epub 2012 Feb 21.
Background: PubMed 18006940Benowitz NL, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Nicotine and carcinogen exposure with smoking of progressively reduced nicotine content cigarette. Cancer Epidemiol Biomarkers Prev. 2007 Nov;16(11):2479-85. doi: 10.1158/1055-9965.EPI-07-0393.
Background: PubMed 26198394Benowitz NL, Nardone N, Dains KM, Hall SM, Stewart S, Dempsey D, Jacob P 3rd. Effect of reducing the nicotine content of cigarettes on cigarette smoking behavior and tobacco smoke toxicant exposure: 2-year follow up. Addiction. 2015 Oct;110(10):1667-75. doi: 10.1111/add.12978. Epub 2015 Jul 21.
Individual participant dataSharing planned: Yes. Data will be available to other researchers, please contact the principal investigator for instructions.

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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.

Eric Donny, PhD principal investigator

Wake Forest University Health Sciences

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NNC Spectrum Cigarette, VLNC Spectrum Cigarette and Moderate nicotine level e-liquid in people with Smoking, run by Wake Forest University Health Sciences at 2 sites 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 2 inclusion and 2 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 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 14 May 2021). 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?

Total Cigarettes Smoked Per Day (time frame: Week 10 through Week 12). 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 NCT03185546, which also lists 26 linked publications.

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 14 May 2021.