This study aims to determine the health effects of very low nicotine content in cigarettes, in conjunction with the availability of nicotine-containing electronic cigarettes (e-cigs) among smokers with mental health conditions (SMHC).
The specific objective of this study is to recruit a cohort of 240 current exclusive daily SMHC (diagnosed using the MINI International Neuropsychiatric Interview) and to measure a comprehensive battery of behavioral and health indicators at 4, 8, 12 and 16 weeks after being randomized to use either normal nicotine content (NNC) Spectrum cigarettes (11.6 mg nicotine/cigarette) or very low nicotine content (VLNC) Spectrum cigarettes (0.2 mg nicotine/cigarette) while also having access to an electronic cigarette (containing either 0 nicotine or high nicotine e-liquid) in a randomized double-blind, placebo-controlled, 2 by 2 design. All participants will be followed up with a study visit 4 weeks after the final randomized visit to identify whether they have continued to use e-cigs/cigarettes and to assess their motivation in smoking abstinence. Our central hypothesis is that key markers of harms to health (e.g. urinary NNAL, exhaled carbon monoxide, measures of addiction, and mental distress) will be significantly improved among SMHC who are provided VLNC cigarettes and high nicotine e-cigs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
88
Research cigarettes with 11.6 mg nicotine/cigarette.
E-cigarette containing high nicotine e-liquid
Research cigarettes with 0.2 mg nicotine/cigarette.
Penn State College of Medicine
Hershey, Pennsylvania, United States
Urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)
Measure of tobacco-specific nitrosamine
Time frame: Week 16
Exhaled Carbon Monoxide
Measure of cigarette smoke exposure
Time frame: Week 16
Kessler-6 Score
Measure of serious psychological distress. This scale is a brief, self-report tool used to assess psychological distress. Scores range from 0-24, with higher scores indicating greater distress
Time frame: Week 16
Penn State Cigarette Dependence Index
Measure of cigarette dependence. This 10-item scale (with scores ranging from 0 to 20) was developed to measure cigarette dependence, where a score of 0 indicates no cigarette dependence and 20 indicates maximum cigarette dependence.
Time frame: Week 16
Penn State Electronic Cigarette Dependence Index
Measure of e-cigarette dependence. This 10-item scale (with scores ranging from 0 to 20) was developed to measure e-cigarette dependence, where a score of 0 indicates no cigarette dependence and 20 indicates maximum e-cigarette dependence.
Time frame: Week 16
Cigarette Abstinence
No cigarette use in the past 7 days and exhaled carbon monoxide \< 6ppm
Time frame: Week 20
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E-cigarette containing zero nicotine e-liquid