A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior
- Conditions
- Cigarette Smoking-Related Carcinoma
- Interventions
- Registration Number
- NCT06260683
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- >= 21 years old
- Smoke >= 5 cigarettes per day for the past year
- Willing to use either an EC or NRT
- Read and speak English
- Have a smartphone
- 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
- History of cardiac event or distress within the past 3 months
- Currently pregnant, planning to become pregnant within 6 months, or breastfeeding
- High blood pressure not controlled by medications
- Serious angina pectoris or chest pain
- Stroke within the past three months
- Known allergy to propylene glycol or vegetable glycerin
- Serious underlying arrhythmias, irregular heartbeat or abnormal heart rhythm
- Live in same household as another study participant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (PEC) Questionnaire Administration Participants receive PEC 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. Arm III (NRT) Questionnaire Administration 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. Arm I (PEC) Vaping Participants receive PEC 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. Arm II (TEC) Vaping Participants receive TEC 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. Arm II (TEC) Questionnaire Administration Participants receive TEC 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. Arm III (NRT) Nicotine Replacement 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.
- Primary Outcome Measures
Name Time Method 7-day point prevalence complete switching rate At week 14 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 At week 14 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 At week 14 Cigarettes smoked per day as evaluated with the timeline follow-back questionnaire.
- Secondary Outcome Measures
Name Time Method Change in cigarettes smoked per day From baseline to 26 weeks Changes in cigarettes smoked per day from baseline to 26 weeks will be evaluated with the timeline follow-back questionnaire.
Change in nicotine dependence From baseline to 14 weeks 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 At baseline, 2, 6, 14, and 26 weeks 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 At 2, 6, and 14 weeks 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.
Number of days used in past month At 6 and 14 weeks 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.
Product appeal At 2, 6, 14, and 26 weeks EC appeal is measured with the modified Cigarette Evaluation Questionnaire (mCEQ) to assess subjected responses to ECs (e.g., reward, satisfaction).
Continued use of ECs From 14 to 26 weeks The proportion of participants who continue to use ECs between 14 and 26 weeks in the PEC and TEC arms.
Trial Locations
- Locations (1)
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States