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

Smoking, Cigarette Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03502200
• Other study ID #: OSU-19133
• Secondary ID: U01DA045537
• Status: Completed
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: June 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking, Cigarette

Intervention

Device:
• JUUL
Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.

Other:
• Treatment As Usual
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tobacco Use History Questionnaire - Years of Smoking	Assess years of smoking from the tobacco use history questionnaire	Week 1 (baseline)
Other	Tobacco Use History Questionnaire - Cigarettes Per Day	Assess average number of cigarettes per day with the tobacco use history questionnaire	Week 1 (baseline)
Other	Tobacco Use History Questionnaire - 24-hour Quit Attempts	Assess number of previous 24-hour quit attempts with the tobacco use history questionnaire	Week 1 (baseline)
Other	Tobacco Use History Questionnaire - Number of Smokers in the Household	Assess number of smokers in the household with the tobacco use history questionnaire	Week 1 (baseline)
Other	Tobacco Use History Questionnaire - Cigarette Expectance Effects	Assess cigarette expectance effects with the tobacco use history questionnaire	Week 1 (baseline)
Other	Tobacco Use History Questionnaire	Assess frequency of use all of nicotine/tobacco products including cigars, cigarillos, little cigars, smokeless tobacco, EC, and hookah.	Week 1 (Baseline)
Primary	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
Primary	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	Sociodemographic Questionnaire - Age	Assess participant age from the sociodemographic questionnaire	Baseline
Secondary	Sociodemographic Questionnaire - Sex	Assess participant sex from the sociodemographic questionnaire	Baseline
Secondary	Sociodemographic Questionnaire - Marital Status	Assess participant marital status from the sociodemographic questionnaire	Baseline
Secondary	Sociodemographic Questionnaire - Ethnicity	Assess participant ethnicity from the sociodemographic questionnaire	Baseline
Secondary	Sociodemographic Questionnaire - Employment Status	Assess participant employment status from the sociodemographic questionnaire	Baseline
Secondary	Sociodemographic Questionnaire - Socioeconomic Status	Assess participant socioeconomic status via yearly household income	Baseline
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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