Clinical trial NCT02587312: Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers
Official title: Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-10-27
Enrollment: 70
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of cigarettes smoked per day
timeFrame: End of 3-week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University School of Public Health
state: Rhode Island
Study officials:
References: