N/A N=80 Randomized Triple-blind Other

Evaluating New Nicotine Standards for Cigarettes - Project 3

Smoking, Cigarette · Electronic Cigarettes

Bottom Line

View on ClinicalTrials.gov: NCT03194256 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2023

Primary outcome: Primary: Number of Cigarette Puffs Taken (0 to 20) — 12.1; 10.8 Puffs chosen

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Spectrum Research Cigarettes (Behavioral)
Age: Pediatric, Adult · 15+ yrs
Sex: All
Sponsor: Brown University
Primary completion: Oct 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Cigarette Puffs Taken (0 to 20)	12.1; 10.8	—
PRIMARY Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 3mg/ml of Nicotine and Was Available in Tobacco Flavor	8.9; 5.2	—
PRIMARY 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	8.0; 4.6	—
PRIMARY Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 18mg/ml of Nicotine and Was Available in Tobacco Flavor	9.4; 4.7	—
PRIMARY 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	8.6; 4.5	—
SECONDARY Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Tobacco Flavor	6.6; 10.5	—
SECONDARY 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	7.2; 11.0	—
SECONDARY Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Tobacco Flavor	4.3; 8.2	—
SECONDARY 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	5.2; 11.0	—
SECONDARY Carbon Monoxide Change From pre-to the Post-choice Task When no Vaping Device Was Available	5.9; 6.7	—
SECONDARY 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	4.4; 3.8	—
SECONDARY 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	3.9; 3.6	—
SECONDARY 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	4.3; 2.7	—
SECONDARY 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	4.0; 3.3	—

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.

Eligibility Criteria

Inclusion Criteria

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 3)
Speak, comprehend, and read English well enough to complete study procedures

Exclusion Criteria

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))
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03194256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.