NCT02587312

Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 15 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine how reducing the level of nicotine in cigarettes may affect adolescent smoking behavior. In this study, the researchers will randomize adolescent (age 15-19) daily smokers to either receive VLNC cigarettes or normal-nicotine content (NNC) study cigarettes for three weeks following a one-week usual-brand baseline period. Participants will be instructed to smoke only those cigarettes. The researchers will conduct daily assessments of total cigarette use (both study cigarette and non-compliant use of usual brand cigarettes), craving, and withdrawal, weekly assessments of breath carbon monoxide (CO) levels, cigarette acceptability, risk perceptions of VLNC and NNC cigarettes and demand for usual-brand cigarettes, and pre- vs. post-use measures of nicotine and toxicant exposure. Overall, the project will help determine how VLNC cigarettes may affect real-world smoking behavior in adolescents, and illuminate the potential mechanisms through which these products may effect such changes. Such knowledge will contribute to the science base that may inform future policy decisions.

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
OTHER	Very low nicotine content cigarettes
OTHER	Standard nicotine content cigarettes

Timeline

• Start date: 2016-10-13
• Primary completion: 2019-08-28
• Completion: 2019-08-31
• First posted: 2015-10-27
• Last updated: 2022-10-27

Locations

1 site across 1 country: United States