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

Not Applicable

Completed

Conditions: Smoking, Cigarette

Interventions: Other: Treatment As Usual
Device: JUUL

Registration Number: NCT03502200

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary: 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: 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 350

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment As Usual	Treatment As Usual	Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
E-cigarette	JUUL	5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence	12 weeks	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.
Proportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes	Daily for 12 weeks	Self-Reported 7-day Point Prevalence Abstinence from Cigarettes to assess complete product switching/substitution.

Secondary Outcome Measures

Name	Time	Method
Sociodemographic Questionnaire - Age	Baseline	Assess participant age from the sociodemographic questionnaire
Sociodemographic Questionnaire - Ethnicity	Baseline	Assess participant ethnicity from the sociodemographic questionnaire
Change in Motivation Rulers (Scale) From Baseline to Week 12	12 Weeks	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.
Sociodemographic Questionnaire - Sex	Baseline	Assess participant sex from the sociodemographic questionnaire
Sociodemographic Questionnaire - Employment Status	Baseline	Assess participant employment status from the sociodemographic questionnaire
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)	12 Weeks	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.
Minnesota Nicotine Withdrawal Scale	12 Weeks	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).
Sociodemographic Questionnaire - Marital Status	Baseline	Assess participant marital status from the sociodemographic questionnaire
Sociodemographic Questionnaire - Socioeconomic Status	Baseline	Assess participant socioeconomic status via yearly household income
Cigarette/EC Dependency Scale	12 weeks	Assess e-cigarette and cigarette dependence. Scores range from 5 to 25 with higher scores indicating a greater level of dependence.
Drug Effects/Liking Questionnaire	12 weeks	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)
Cigarette Purchase Task - Breakpoint	Week 1 (Baseline)	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?".