Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers
| Status: | Recruiting |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 15 - 19 |
| Updated: | 7/12/2018 |
| Start Date: | October 13, 2016 |
| End Date: | September 2019 |
| Contact: | Rachel N Cassidy, Ph.D |
| Email: | Rachel_cassidy@brown.edu |
| Phone: | (401)863-6621 |
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.
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.
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
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