Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failures

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failure

Conditions
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Smoking, Cigarette

Intervention / Treatment
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* Device: JUUL
* Other: Treatment As Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: smoke ≥5 cigarettes per day for the past year read, write, and speak in English report at least minimal interest in switching to an alternative product (> not at all on a Likert scale) participation in the Oklahoma Tobacco Helpline or South Carolina Tobacco Helpline within the last 4-7 months. Exclusion Criteria: <21 years old report NRT use or making a quit attempt within the last 7 days current daily use of an e-cigarette over last month. unstable or significant medical condition such as respiratory, kidney, or liver disease unstable or significant psychiatric conditions (past and stable conditions will be allowed) history of cardiac event or distress within the past 6 months currently pregnant, planning to become pregnant, or breastfeeding. currently enrolled in a contradictory study. cohabitates with a currently enrolled participant in the REACH study reaction to using patch medication or adhesive tape known allergy to propylene glycol or vegetable glycerin

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be assigned to one of two conditions randomly.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-cigarette<br>5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling. | Device: JUUL<br>* Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.<br>|
| Active Comparator: Treatment As Usual<br>Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling. | Other: Treatment As Usual<br>* Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic Questionnaire - Age | Assess participant age from the sociodemographic questionnaire | Baseline | 
| Sociodemographic Questionnaire - Sex | Assess participant sex from the sociodemographic questionnaire | Baseline | 
| Sociodemographic Questionnaire - Marital Status | Assess participant marital status from the sociodemographic questionnaire | Baseline | 
| Sociodemographic Questionnaire - Ethnicity | Assess participant ethnicity from the sociodemographic questionnaire | Baseline | 
| Sociodemographic Questionnaire - Employment Status | Assess participant employment status from the sociodemographic questionnaire | Baseline | 
| Sociodemographic Questionnaire - Socioeconomic Status | Assess participant socioeconomic status via yearly household income | 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. | 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) | 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?. | 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. | 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). | 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. | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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e-cigarettes, harm reduction, smoking behavior