NCT03194256: CENIC2-P3

Evaluating New Nicotine Standards for Cigarettes - Project 3

Completed NA Results posted Last updated 18 December 2023

What this trial tests

NA trial testing Spectrum Research Cigarettes in Smoking, Cigarette in 80 participants. Completed in 30 November 2022.

Timeline

1 September 2018

Primary endpoint
28 October 2022

30 November 2022

Quick facts

Lead sponsor	Brown University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	80
Start date	1 September 2018
Primary completion	28 October 2022
Estimated completion	30 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Spectrum Research Cigarettes

Conditions studied

• Smoking, Cigarette — all drugs for Smoking, Cigarette →
• Electronic Cigarettes — all drugs for Electronic Cigarettes →

Sponsor

Brown University

Who can join

Adults 15 to 20, any sex, with Smoking, Cigarette or Electronic Cigarettes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Cigarette Puffs Taken (0 to 20) Primary · 30-minute preference task

The number of cigarette puffs selected during a 30 minute choice procedure when no vaping device was available

Group	Value	95% CI
Normal Nicotine Content Cigarettes	12.1	± 5.0
Very Low Nicotine Content Cigarettes	10.8	± 5.3

Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 3mg/ml of Nicotine and Was Available in Tobacco Flavor Primary · 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

Group	Value	95% CI
Normal Nicotine Content Cigarettes	8.9	± 5.6
Very Low Nicotine Content Cigarettes	5.2	± 5.4

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 Primary · 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

Group	Value	95% CI
Normal Nicotine Content Cigarettes	8.0	± 5.0
Very Low Nicotine Content Cigarettes	4.6	± 4.3

Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 18mg/ml of Nicotine and Was Available in Tobacco Flavor Primary · 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

Group	Value	95% CI
Normal Nicotine Content Cigarettes	9.4	± 5.4
Very Low Nicotine Content Cigarettes	4.7	± 5.1

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 Primary · 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

Group	Value	95% CI
Normal Nicotine Content Cigarettes	8.6	± 5.4
Very Low Nicotine Content Cigarettes	4.5	± 4.2

Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Tobacco Flavor Secondary · 30-minute preference task session

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

Group	Value	95% CI
Normal Nicotine Content Cigarettes	6.6	± 5.0
Very Low Nicotine Content Cigarettes	10.5	± 6.1

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 Secondary · 30-minute preference task session

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

Group	Value	95% CI
Normal Nicotine Content Cigarettes	7.2	± 4.6
Very Low Nicotine Content Cigarettes	11.0	± 6.0

Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Tobacco Flavor Secondary · 30-minute preference task session

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

Group	Value	95% CI
Normal Nicotine Content Cigarettes	4.3	± 4.3
Very Low Nicotine Content Cigarettes	8.2	± 6.6

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 Secondary · 30-minute preference task session

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

Group	Value	95% CI
Normal Nicotine Content Cigarettes	5.2	± 5.0
Very Low Nicotine Content Cigarettes	11.0	± 5.6

Carbon Monoxide Change From pre-to the Post-choice Task When no Vaping Device Was Available Secondary · 30-minute preference task

Post-choice CO minus pre-choice CO at session 1 in which no vaping device was available

Group	Value	95% CI
Normal Nicotine Content Cigarettes	5.9	± 4.3
Very Low Nicotine Content Cigarettes	6.7	± 4.5

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 Secondary · 30-minute preference task

Post-choice CO minus pre-choice CO when the available vaping device contained 3mg/ml nicotine and was available in tobacco flavor

Group	Value	95% CI
Normal Nicotine Content Cigarettes	4.4	± 3.2
Very Low Nicotine Content Cigarettes	3.8	± 3.2

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 Secondary · 30-minute preference task

Post-choice CO minus pre-choice CO when the available vaping device contained 3mg/ml nicotine and was available in non-tobacco flavors

Group	Value	95% CI
Normal Nicotine Content Cigarettes	3.9	± 3.6
Very Low Nicotine Content Cigarettes	3.6	± 2.9

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Qualitative reactions to a low nicotine product standard for cigarettes from adolescents and young adults living in the United States who smoke.
   Denlinger-Apte RL, Cassidy RN, Donny EC, Godin J, et al · · 2023 · cited 3× · PMID 36895826 · DOI 10.1016/j.pmedr.2023.102163
2. Effects of Very Low Nicotine Content Cigarettes and Nicotine Vaping Device Characteristics on Choices to Smoke, Vape, or Abstain in Early Young Adults.
   Cassidy RN, Tidey JW, Bello MS, Denlinger-Apte R, et al · · 2025 · PMID 39109883 · DOI 10.1093/ntr/ntae194