Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers

Nicotine Dependence Clinical Trial

Official title:

Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587312
• Other study ID #: 1K01CA189300
• Status: Completed
• Phase: N/A
• Start date: October 13, 2016
• Est. completion date: August 31, 2019

Study information

• Verified date: October 2022
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 31, 2019
• Est. primary completion date: August 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

Inclusion Criteria:

• current daily smoking (1 or more cigarettes per day for the past 6 months or longer). Participants must meet a breath carbon monoxide criterion of 6 ppm or higher; if this is not met, urine cotinine levels, detected by a NicAlert cotinine screening device, must indicate recent smoking (level 3 or higher).
• Participants must speak and comprehend English well enough to complete study procedures.

Exclusion Criteria:

• Current pregnancy
• Self-reported daily use of alcohol or other non-prescribed drugs (excluding marijuana).
• Participants who are seeking treatment for their smoking or who report that they intend to quit smoking within the next 30 days and have made a 24-hour quit attempt in the past year
• Participants who report current suicidal ideation on the MINI suicide subscale questions 4 & 5 ("In the past month did you have a suicide plan?" and "In the past month did you attempt suicide?"), as well as participants who indicate that they have made a suicide attempt in their lifetime
• Participants who report use of other non-cigarette tobacco products more than 9 out of the last 30 days

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Other:
• Very low nicotine content cigarettes

• Standard nicotine content cigarettes

Locations

Country	Name	City	State
United States	Brown University School of Public Health	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cigarettes smoked per day		End of 3-week intervention