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.
PRIMARY OBJECTIVES: I. Determine PEC versus vs. TEC vs. nicotine replacement therapy (NRT) on tobacco use patterns including product switching, abstinence from cigarettes, and number of cigarettes smoked. II. Examine PEC vs. TEC vs. NRT on cigarette craving, withdrawal symptoms, and perceived nicotine dependence. III. Examine PEC vs. TEC on product appeal and uptake, including initial trial, days used during period of product provision, and purchase and continued use after 12 weeks. OUTLINE: Participants are randomized to 1 of 3 arms. ARM I: Participants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. ARM II: Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. ARM III: Participants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial. SURVEILLANCE PHASE: Participants in all arms are followed for 12-weeks after completion of study procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,500
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
RECRUITING7-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.
Time frame: At week 14
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).
Time frame: At week 14
Cigarettes smoked per day
Cigarettes smoked per day as evaluated with the timeline follow-back questionnaire.
Time frame: At week 14
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.
Time frame: From baseline to 26 weeks
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.
Time frame: From baseline to 14 weeks
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.
Time frame: At baseline, 2, 6, 14, and 26 weeks
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.
Time frame: At 2, 6, and 14 weeks
Number of days used in past month
The number of days the study products are used in the past 30 days during the period of product provision in the PEC and TEC arms.
Time frame: At 6 and 14 weeks
Product appeal
EC appeal is measured with the modified Cigarette Evaluation Questionnaire (mCEQ) to assess subjected responses to ECs (e.g., reward, satisfaction).
Time frame: At 2, 6, 14, and 26 weeks
Continued use of ECs
The proportion of participants who continue to use ECs between 14 and 26 weeks in the PEC and TEC arms.
Time frame: From 14 to 26 weeks
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