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Completed

NCT Number: NCT03502200

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

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.

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Key information

Conditions

Smoking, Cigarette Behavior Cigarette Smoking Harm Reduction Smoking Tobacco Smoking Tobacco Use Vaping

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JUUL

Device

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

Treatment as Usual

Other

Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.

Primary outcomes

  1. Proportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes

    Time frame: Daily for 12 weeks

    Self-Reported 7-day Point Prevalence Abstinence from Cigarettes to assess complete product switching/substitution.

  2. Proportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence

    Time frame: 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.

Secondary outcomes

  1. Sociodemographic Questionnaire - Age

    Time frame: Baseline

    Assess participant age from the sociodemographic questionnaire

  2. Sociodemographic Questionnaire - Sex

    Time frame: Baseline

    Assess participant sex from the sociodemographic questionnaire

  3. Sociodemographic Questionnaire - Marital Status

    Time frame: Baseline

    Assess participant marital status from the sociodemographic questionnaire

  4. Sociodemographic Questionnaire - Ethnicity

    Time frame: Baseline

    Assess participant ethnicity from the sociodemographic questionnaire

  5. Sociodemographic Questionnaire - Employment Status

    Time frame: Baseline

    Assess participant employment status from the sociodemographic questionnaire

  6. Sociodemographic Questionnaire - Socioeconomic Status

    Time frame: Baseline

    Assess participant socioeconomic status via yearly household income

  7. Cigarette/EC Dependency Scale

    Time frame: 12 weeks

    Assess e-cigarette and cigarette dependence.

    Scores range from 5 to 25 with higher scores indicating a greater level of dependence.

  8. Drug Effects/Liking Questionnaire

    Time frame: 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)

  9. Cigarette Purchase Task - Breakpoint

    Time frame: 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?".

  10. Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)

    Time frame: 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.

  11. Minnesota Nicotine Withdrawal Scale

    Time frame: 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).

  12. Change in Motivation Rulers (Scale) From Baseline to Week 12

    Time frame: 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.

Other outcomes

  1. Tobacco Use History Questionnaire - Years of Smoking

    Time frame: Week 1 (baseline)

    Assess years of smoking from the tobacco use history questionnaire

  2. Tobacco Use History Questionnaire - Cigarettes Per Day

    Time frame: Week 1 (baseline)

    Assess average number of cigarettes per day with the tobacco use history questionnaire

  3. Tobacco Use History Questionnaire - 24-hour Quit Attempts

    Time frame: Week 1 (baseline)

    Assess number of previous 24-hour quit attempts with the tobacco use history questionnaire

  4. Tobacco Use History Questionnaire - Number of Smokers in the Household

    Time frame: Week 1 (baseline)

    Assess number of smokers in the household with the tobacco use history questionnaire

  5. Tobacco Use History Questionnaire - Cigarette Expectance Effects

    Time frame: Week 1 (baseline)

    Assess cigarette expectance effects with the tobacco use history questionnaire

  6. Tobacco Use History Questionnaire

    Time frame: Week 1 (Baseline)

    Assess frequency of use all of nicotine/tobacco products including cigars, cigarillos, little cigars, smokeless tobacco, EC, and hookah.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2018
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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