This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) vs. non-tobacco flavored ECs vs. nicotine replacement therapy (patches and lozenges) on smoking behavior in current cigarette smokers. ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use and learn how ECs affect smoking behaviors and health.
>= 21 years old
Smoke >= 5 cigarettes per day for the past year
Willing to use either an EC or NRT
Read and speak English
Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation
Current use of an EC > 4 days a month
Diagnosed medical conditions of lung disease, asthma, cystic fibrosis, heart disease or chronic obstructive pulmonary disease (COPD)
Unmanaged (unmedicated and/or without counseling) diagnosis of schizophrenia
Parallel
Nicotine Replacement
DrugGiven nicotine patches and nicotine lozenges
Questionnaire Administration
Other interventionAncillary studies
Vaping
DeviceGiven Preferred Flavor e-liquid
Vaping
DeviceGiven Tobacco flavored e-liquid
7-day point prevalence complete switching rate
Self-reported 7-day point prevalence abstinence (no cigarettes, not even a puff, in the previous 7 days), any reported use of ECs or NRT over the past 7 days, and an exhaled CO reading of ≤6ppm.
Biochemically verified 7-day point prevalence abstinence from cigarettes
Biochemical verification of abstinence from cigarettes (exhaled CO reading of ≤6ppm) combined with self-reported 7-day point prevalence abstinence (no cigarettes, not even a puff, in the previous 7 days).
Cigarettes smoked per day
Cigarettes smoked per day as evaluated with the timeline follow-back questionnaire.
Change in cigarettes smoked per day
Changes in cigarettes smoked per day from baseline to 26 weeks will be evaluated with the timeline follow-back questionnaire.
Change in nicotine dependence
Among participants abstaining from smoking, changes in nicotine dependence from baseline to 14 weeks will be assessed in the PEC, TEC, and NRT arms with the PROMIS nicotine dependence scale. Scores range from 0 to 16 with higher scores indicating greater dependence.
Changes in cigarette craving and nicotine withdrawal
Cigarette craving and nicotine withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS). Total MPSS scores range from 12 to 60 with higher scores indicating a greater severity of tobacco withdrawal symptoms.
Number of days used in past week
The number of days the study products are used in the past 7 days during the period of product provision in the PEC and TEC arms.
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Ohio State University Comprehensive Cancer Center
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
