Examination of Low Wattage and High Wattage E-Cigarettes (SWITCH)

March 30, 2026 updated by: Theodore Wagener, Ohio State University Comprehensive Cancer Center
The overall aim of the proposed study is to evaluate the effect of switching from conventional cigarettes to either a LWe or HWe on smoking behavior, product use patterns and continued use, as well as biomarkers of toxicant exposure and effects.

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.

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.
372

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, 43214
        • The 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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. smoke ≥5 cigarettes per day for the past year;
  2. no quit attempt in the prior 3 months and no plan to quit in the next 3 months;
  3. read, write, and speak in English;
  4. report at least minimal interest in switching to an alternative product (> "not at all" on a Likert scale);
  5. never purchased or regularly used a tank system, mechanical mod, or advanced personal vaporizer EC, though previous use of cig-a-like devices will be allowed but not in the last 3 months;
  6. plan to live in the local area for next year; and
  7. have reliable means of transport. -

Exclusion Criteria:

  1. <18 years old;
  2. unstable or significant medical condition such as respiratory, kidney, or liver disease that could potentially affect biomarker data;
  3. unstable or significant psychiatric conditions (past and stable conditions will be allowed);
  4. history of cardiac event or distress within the past 3 months; and

  5. currently pregnant, planning to become pregnant, or breastfeeding (n.b: pregnancy status will continue to be evaluated throughout the study at each visit).

    -

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: Basic Science
  • 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.
Active Comparator: Low wattage E cigarette device
Behavioral: Low wattage E cigarette device
The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
Active Comparator: High wattage E cigarette device
Behavioral: High wattage E cigarette device
The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
Active Comparator: Usual brand cigarette
Behavioral: Usual brand cigarette
The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.

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
Complete Change From Conventional Cigarettes - Self Report
Time Frame: Week 4, Week 8, Week 12, Week 26, and Week 52

Self-Reported 7-day Point Prevalence Abstinence from Cigarettes evaluated via the Timeline Follow Back Questionnaire.

An intent-to-treat approach is taken where no participants are excluded and missing data is imputed as not abstinent from cigarettes.
Week 4, Week 8, Week 12, Week 26, and Week 52
Complete Change From Conventional Cigarettes - Biochemically Verified
Time Frame: Week 4, Week 8, Week 12, Week 26, and Week 52

Intent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an exhaled carbon monoxide reading less than or equal to 10.

An intent-to-treat approach is taken where no participants are excluded and missing data is imputed as not abstinent from cigarettes.
Week 4, Week 8, Week 12, Week 26, and Week 52

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
Cigarette Dependence
Time Frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 26 and Week 52
Cigarette Dependence Scale Scores range from 12 to 60 with higher scores indicating greater dependence.
Baseline, Week 1, Week 4, Week 8, Week 12, Week 26 and Week 52
Cigarette Likeability/Preference
Time Frame: Baseline, Week 4, Week 12, Week 26, and Week 52
Cigarette Evaluation Scale Scores range from 1 to 7 with higher scores indicating greater satisfaction, psychological reward, aversion, or relief
Baseline, Week 4, Week 12, Week 26, and Week 52
EC Likeability/Preference
Time Frame: Week 4, Week 12

EC modified-Cigarette Evaluation Scale Scores range from 1 to 7 with higher scores indicating greater satisfaction, psychological reward, aversion, or relief.

No results are reported for the Usual Brand Cigarette arm as the participants in this arm did not receive a study e-cigarette device and thus were not asked to respond to the e-cigarette modified cigarette evaluation scale items.
Week 4, Week 12
EC Abuse Liability
Time Frame: Week 4, Week 12, Week 26, and Week 52
An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of all three study products. Five visual analog scale items ranging from 0 ('not at all') to 100 ('extremely') assessed wanting to smoke the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying.
Week 4, Week 12, Week 26, and Week 52
Biomarker of Exposure - Nicotine Metabolite Ratio
Time Frame: Baseline, Week 4, Week 12
Biomarker of nicotine clearance formed using the ratio of 2 nicotine metabolites (3'hydroxycotinine [3HC]/cotinine)
Baseline, Week 4, Week 12
Biomarker of Exposure - PGEM
Time Frame: Baseline, Week 4, Week 12
Urinary biomarker of oxidative stress and inflammation
Baseline, Week 4, Week 12
Biomarker of Exposure - NNAL
Time Frame: Baseline, Week 4, Week 12
Urinary total 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanol [NNAL] (pmol/mg creatinine)
Baseline, Week 4, Week 12
Biomarker of Exposure - NNN
Time Frame: Baseline, Week 4, Week 12
Presence of urinary [pyridine-D4]NNN ([D4]NNN) (pmol/mg creatinine)
Baseline, Week 4, Week 12
Biomarker of Exposure - Total Nicotine Equivalents (TNE)
Time Frame: Baseline, Week 4, Week 12
Sum of nicotine and metabolites in urine - Total Nicotine Equivalents (TNE) (nmol/mg creatinine)
Baseline, Week 4, Week 12
Biomarker of Exposure - Nickel
Time Frame: Baseline, Week 4, Week 12
Metals and metalloids in saliva - Nickel (ng/mL)
Baseline, Week 4, Week 12
Biomarker of Exposure - Cadmium
Time Frame: Baseline, Week 4, Week 12
Metals and metalloids in saliva - Cadmium (ng/mL)
Baseline, Week 4, Week 12
Biomarker of Exposure - Lead
Time Frame: Baseline, Week 4, Week 12
Metals and metalloids in saliva - Lead (ng/mL)
Baseline, Week 4, Week 12
Biomarker of Exposure - 8-iso-PGF2a
Time Frame: Baseline, Week 4, Week 12
Urinary biomarker of oxidative stress and inflammation - 8-iso-PGF2a (pmol/mg creatinine)
Baseline, Week 4, Week 12
Biomarker of Effect - q-PADDA
Time Frame: Week 4, Week 12
Data is shown as change in DNA damage from baseline. We calculated change in DNA damage in Transcribed (TS) and Non-transcribed strand (NTS) and added those data points to calculate the Total Change in DNA damage. Results are presented as change in number of DNA lesions per 10,000 base pairs.
Week 4, Week 12

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 Cancer Institute (NCI)
National Institutes of Health (NIH)
University of Minnesota

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 Wagener, PhD, Ohio State Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
June 29, 2017

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, 2022

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, 2022

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).
March 22, 2017

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 7, 2017

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 13, 2017

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.
April 17, 2026

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.
March 30, 2026

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.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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-19095
  • R01CA204891-01 (U.S. NIH Grant/Contract)
  • NCI-2019-01855 (Registry Identifier: CTRP (Clinical Trial Reporting Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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