The overall aim of the study is to evaluate the provision of e-cigarette (EC) versus NRT on smoking behavior, product use patterns and continued use, and iCO, a biomarker of toxicant exposure, among a sample of recent QL treatment failures. We will randomly assign N=372 smokers (targeted accrual) to EC (n=186) or QL treatment as usual with combination nicotine replacement therapy (NRT; n=186). All participants will receive three calls from QL coaches and EC and NRT will be provided at no cost for 8 weeks. The final follow-up will occur 12-weeks post baseline.
There remains a lack of prospective and controlled research on the behavioral, toxicological, and physiological effects of electronic cigarettes (ECs) to help the public health community come to a clear and accurate consensus on their risk-benefit. In order to successfully execute the proposed study, the investigators plan to recruit and enroll recent smoking cessation treatment failures from a state QL, which predominately serves priority populations (e.g., low socioeconomic status, high levels of mental health conditions). The proposed study will randomly assign smokers who were recent QL treatment failures to a) EC (JUUL 5%) or b) QL treatment as usual with combination nicotine replacement therapy control (NRT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
350
Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Proportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes
Self-Reported 7-day Point Prevalence Abstinence from Cigarettes to assess complete product switching/substitution.
Time frame: Daily for 12 weeks
Proportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence
Intent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an iCO reading less than or equal to 8. A portable exhaled carbon monoxide detector confirms daily smoking status. Used to evaluate changes iCO, a biomarker of tobacco constituent exposure and other health effects.
Time frame: 12 weeks
Sociodemographic Questionnaire - Age
Assess participant age from the sociodemographic questionnaire
Time frame: Baseline
Sociodemographic Questionnaire - Sex
Assess participant sex from the sociodemographic questionnaire
Time frame: Baseline
Sociodemographic Questionnaire - Marital Status
Assess participant marital status from the sociodemographic questionnaire
Time frame: Baseline
Sociodemographic Questionnaire - Ethnicity
Assess participant ethnicity from the sociodemographic questionnaire
Time frame: Baseline
Sociodemographic Questionnaire - Employment Status
Assess participant employment status from the sociodemographic questionnaire
Time frame: Baseline
Sociodemographic Questionnaire - Socioeconomic Status
Assess participant socioeconomic status via yearly household income
Time frame: Baseline
Cigarette/EC Dependency Scale
Assess e-cigarette and cigarette dependence. Scores range from 5 to 25 with higher scores indicating a greater level of dependence.
Time frame: 12 weeks
Drug Effects/Liking Questionnaire
Assess the desire and liking of products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness Scores range from 1 to 5 with higher scores indicating greater strength (effect from smoking cigarettes/vaping e-cigarettes) or liking (liking of effect from smoking cigarettes/vaping e-cigarettes)
Time frame: 12 weeks
Cigarette Purchase Task - Breakpoint
Asks participants how much they would be willing to pay (ranging from 0¢ to $1,120) for a puff of their own brand cigarette. Specifically they will be asked, "How much would you be willing to pay for a puff of your usual cigarette brand?".
Time frame: Week 1 (Baseline)
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
Smoking and vaping urges/craving will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form with a modified version (replacing the word "cigarette" with "e-cigarette") for EC users. This is a 10-item measure where participants rate smoking/vaping-related items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke/vape; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving to smoke/vape.
Time frame: 12 Weeks
Minnesota Nicotine Withdrawal Scale
Asses Nicotine withdrawal and smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). Scores range from 0 to 4 with higher scores indicating greater levels of withdrawal (MNWS) or more craving to smoke (MNWS Craving).
Time frame: 12 Weeks
Change in Motivation Rulers (Scale) From Baseline to Week 12
Assess for changes in motivation from baseline to week 12 among participants who continue to smoke. Rulers including importance, confidence, and readiness to quit smoking (3-items total, with a scale ranging from 0 "not at all important/confident/ready" to 10 "extremely important/confident/ready"). Medians reported are change from baseline \[week 12 score - baseline score\] where negative values indicate a decrease in motivation over time and positive values indicate an increase in motivation over time.
Time frame: 12 Weeks
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