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

June 28, 2023 updated by: Theodore Wagener, Ohio State University Comprehensive Cancer Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: E-cigarette
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
Device: JUUL
Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
Active Comparator: Treatment As Usual
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Other: Treatment As Usual
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Daily for 12 weeks
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.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sociodemographic Questionnaire - Age
Time Frame: Baseline
Assess participant age from the sociodemographic questionnaire
Baseline
Sociodemographic Questionnaire - Sex
Time Frame: Baseline
Assess participant sex from the sociodemographic questionnaire
Baseline
Sociodemographic Questionnaire - Marital Status
Time Frame: Baseline
Assess participant marital status from the sociodemographic questionnaire
Baseline
Sociodemographic Questionnaire - Ethnicity
Time Frame: Baseline
Assess participant ethnicity from the sociodemographic questionnaire
Baseline
Sociodemographic Questionnaire - Employment Status
Time Frame: Baseline
Assess participant employment status from the sociodemographic questionnaire
Baseline
Sociodemographic Questionnaire - Socioeconomic Status
Time Frame: Baseline
Assess participant socioeconomic status via yearly household income
Baseline
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.
12 weeks
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)
12 weeks
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?".
Week 1 (Baseline)
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.
12 Weeks
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 Weeks
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.
12 Weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tobacco Use History Questionnaire - Years of Smoking
Time Frame: Week 1 (baseline)
Assess years of smoking from the tobacco use history questionnaire
Week 1 (baseline)
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
Week 1 (baseline)
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
Week 1 (baseline)
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
Week 1 (baseline)
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Time Frame: Week 1 (baseline)
Assess cigarette expectance effects with the tobacco use history questionnaire
Week 1 (baseline)
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.
Week 1 (Baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University Comprehensive Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Theodore L Wagener, PhD, Ohio State Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OSU-19133
  • U01DA045537 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified and aggregated data will be shared through poster presentations and published manuscripts.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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