Smoking, CigaretteSWITCHNCT03113136

Examination of Low Wattage and High Wattage E-Cigarettes

A study testing Low wattage E cigarette device, High wattage E cigarette device and Usual brand cigarette in people with Smoking, Cigarette and Smoking, Tobacco, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Smoking, Cigarette, Smoking, Tobacco, Nicotine Dependence
What is being tested?: Low wattage E cigarette device, High wattage E cigarette device and Usual brand cigarette
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 372 participants
Where: 1 siteUnited States
Study dates: 29 Jun 2017to 31 Jan 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

smoke ≥5 cigarettes per day for the past year;
no quit attempt in the prior 3 months and no plan to quit in the next 3 months;
read, write, and speak in English;
report at least minimal interest in switching to an alternative product (> "not at all" on a Likert scale);
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;
plan to live in the local area for next year; and
have reliable means of transport. -

Who cannot join

<18 years old;
unstable or significant medical condition such as respiratory, kidney, or liver disease that could potentially affect biomarker data;
unstable or significant psychiatric conditions (past and stable conditions will be allowed);
history of cardiac event or distress within the past 3 months; and
currently pregnant, planning to become pregnant, or breastfeeding (n.b: pregnancy status will continue to be evaluated throughout the study at each visit).
-

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43214

Other trials in United States

About this study

Conditions: Smoking, Cigarette, Smoking, Tobacco, Nicotine Dependence, Exposure to Toxic Agent
Being tested: Low wattage E cigarette device, High wattage E cigarette device, Usual brand cigarette
Medical subject headings: Cigarette Smoking, Tobacco Smoking, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low wattage E cigarette deviceBehavioural
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.
High wattage E cigarette deviceBehavioural
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.
Usual brand cigaretteBehavioural
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.

Study groups in NCT03113136
Study group	Role	What they receive
Low wattage E cigarette device	Active comparator	Not described Receives: Behavioral: Low wattage E cigarette device
High wattage E cigarette device	Active comparator	Not described Receives: Behavioral: High wattage E cigarette device
Usual brand cigarette	Active comparator	Not described Receives: Behavioral: Usual brand cigarette

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete Change From Conventional Cigarettes - Self Report
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.
Measured: Week 4, Week 8, Week 12, Week 26, and Week 52
Complete Change From Conventional Cigarettes - Biochemically Verified
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.
Measured: Week 4, Week 8, Week 12, Week 26, and Week 52

Secondary outcomes (14)

Cigarette Dependence
Cigarette Dependence Scale Scores range from 12 to 60 with higher scores indicating greater dependence.
Measured: Baseline, Week 1, Week 4, Week 8, Week 12, Week 26 and Week 52
Cigarette Likeability/Preference
Cigarette Evaluation Scale Scores range from 1 to 7 with higher scores indicating greater satisfaction, psychological reward, aversion, or relief
Measured: Baseline, Week 4, Week 12, Week 26, and Week 52
EC Likeability/Preference
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.
Measured: Week 4, Week 12
EC Abuse Liability
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.
Measured: Week 4, Week 12, Week 26, and Week 52
Biomarker of Exposure - NNAL
Urinary total 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanol [NNAL] (pmol/mg creatinine)
Measured: Baseline, Week 4, Week 12
Biomarker of Exposure - NNN
Presence of urinary [pyridine-D4]NNN ([D4]NNN) (pmol/mg creatinine)
Measured: Baseline, Week 4, Week 12
Biomarker of Exposure - Total Nicotine Equivalents (TNE)
Sum of nicotine and metabolites in urine - Total Nicotine Equivalents (TNE) (nmol/mg creatinine)
Measured: Baseline, Week 4, Week 12
Biomarker of Exposure - Nickel
Metals and metalloids in saliva - Nickel (ng/mL)
Measured: Baseline, Week 4, Week 12
Biomarker of Exposure - Cadmium
Metals and metalloids in saliva - Cadmium (ng/mL)
Measured: Baseline, Week 4, Week 12
Biomarker of Exposure - Lead
Metals and metalloids in saliva - Lead (ng/mL)
Measured: Baseline, Week 4, Week 12
Biomarker of Exposure - 8-iso-PGF2a
Urinary biomarker of oxidative stress and inflammation - 8-iso-PGF2a (pmol/mg creatinine)
Measured: Baseline, Week 4, Week 12
Biomarker of Effect - q-PADDA
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.
Measured: Week 4, Week 12
Biomarker of Exposure - Nicotine Metabolite Ratio
Biomarker of nicotine clearance formed using the ratio of 2 nicotine metabolites (3'hydroxycotinine [3HC]/cotinine)
Measured: Baseline, Week 4, Week 12
Biomarker of Exposure - PGEM
Urinary biomarker of oxidative stress and inflammation
Measured: Baseline, Week 4, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 201731 Jan 2022

First posted13 Apr 2017
Study start29 Jun 2017
Primary completion31 Jan 2022
Study completion31 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Smoking, CigaretteStudies of the same condition, open and under way.
More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 372 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03113136
Sponsor's protocol ID: OSU-19095
Other IDs: R01CA204891-01, NCI-2019-01855
Acronym: SWITCH
Status last verified: Mar 2026
First submitted: 22 Mar 2017
Last updated: 17 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cho YJ, Hinton A, Nshimiyimana J, Mehta T, Bobu A, Beebe LA, Queimado L, Stepanov I, Brinkman MC, Lee DN, Davis AK, Wagener TL. Changes in preferred e-cigarette flavor, nicotine concentration, wattage and air valve settings and cigarette consumption during a switching trial. Addiction. 2026 Oct 23. doi: 10.1111/add.70687. Online ahead of print.
PubMed 42924544

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Examination of Low Wattage and High Wattage E-Cigarettes
ClinicalTrials.gov ID: NCT03113136
Acronym / sponsor ID: SWITCH / OSU-19095
Conditions: Smoking, Cigarette, Smoking, Tobacco, Nicotine Dependence, Exposure to Toxic Agent
Study type: Interventional
Recruitment status: Completed
Enrolment: 372 participants (actual)
Lead sponsor: Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI), University of Minnesota
Study start: 29 Jun 2017 (actual)
Primary completion: 31 Jan 2022 (actual)
Study completion: 31 Jan 2022 (actual)
First posted: 13 Apr 2017 (actual)
Results: Posted 9 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Low wattage E cigarette device	Active comparator	Behavioral: Low wattage E cigarette device
High wattage E cigarette device	Active comparator	Behavioral: High wattage E cigarette device
Usual brand cigarette	Active comparator	Behavioral: Usual brand cigarette

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

smoke ≥5 cigarettes per day for the past year;
no quit attempt in the prior 3 months and no plan to quit in the next 3 months;
read, write, and speak in English;
report at least minimal interest in switching to an alternative product (> "not at all" on a Likert scale);
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;

Key exclusion criteria (6 listed)

<18 years old;
unstable or significant medical condition such as respiratory, kidney, or liver disease that could potentially affect biomarker data;
unstable or significant psychiatric conditions (past and stable conditions will be allowed);
history of cardiac event or distress within the past 3 months; and
currently pregnant, planning to become pregnant, or breastfeeding (n.b: pregnancy status will continue to be evaluated throughout the study at each visit).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Low wattage E cigarette deviceThe 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.	Behavioural	Low wattage E cigarette device
High wattage E cigarette deviceThe 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.	Behavioural	High wattage E cigarette device
Usual brand cigaretteThe 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.	Behavioural	Usual brand cigarette

Primary outcome

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.
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.

14 secondary outcomes

Cigarette Dependence
Time frame: 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
EC Likeability/Preference
Time frame: Week 4, Week 12
EC Abuse Liability
Time frame: Week 4, Week 12, Week 26, and Week 52
Biomarker of Exposure - NNAL
Time frame: Baseline, Week 4, Week 12
Biomarker of Exposure - NNN
Time frame: Baseline, Week 4, Week 12
Biomarker of Exposure - Total Nicotine Equivalents (TNE)
Time frame: Baseline, Week 4, Week 12
Biomarker of Exposure - Nickel
Time frame: Baseline, Week 4, Week 12
Biomarker of Exposure - Cadmium
Time frame: Baseline, Week 4, Week 12
Biomarker of Exposure - Lead
Time frame: Baseline, Week 4, Week 12
Biomarker of Exposure - 8-iso-PGF2a
Time frame: Baseline, Week 4, Week 12
Biomarker of Effect - q-PADDA
Time frame: Week 4, Week 12
Biomarker of Exposure - Nicotine Metabolite Ratio
Time frame: Baseline, Week 4, Week 12
Biomarker of Exposure - PGEM
Time frame: Baseline, Week 4, Week 12

Results and safety

Results posted to the registry on 9 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Brand Cigarette	105	78
Low Wattage E Cigarette Device	133	67
High Wattage E Cigarette Device	134	65

Primary outcome: Complete Change From Conventional Cigarettes - Self Report

Time frame: Week 4, Week 8, Week 12, Week 26, and Week 52. Count of participants. Unit: Participants

Measure	Usual Brand Cigarette n = 105	Low Wattage E Cigarette Device n = 133	High Wattage E Cigarette Device n = 134
Week 4	0	12	10
Week 8	0	19	10
Week 12	0	16	16
Week 26	5	20	9
Week 52	4	13	8

Primary outcome: Complete Change From Conventional Cigarettes - Biochemically Verified

Time frame: Week 4, Week 8, Week 12, Week 26, and Week 52. Count of participants. Unit: Participants

Measure	Usual Brand Cigarette n = 105	Low Wattage E Cigarette Device n = 133	High Wattage E Cigarette Device n = 134
Week 4	0	10	9
Week 8	0	16	8
Week 12	0	15	11
Week 26	5	18	6
Week 52	4	11	8

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Brand Cigarette	3 of 105 (2.9%)	64 of 105 (61%)	0 of 105
Low Wattage E Cigarette Device	2 of 133 (1.5%)	103 of 133 (77.4%)	0 of 133
High Wattage E Cigarette Device	2 of 134 (1.5%)	95 of 134 (70.9%)	0 of 134

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42924544Cho YJ, Hinton A, Nshimiyimana J, Mehta T, Bobu A, Beebe LA, Queimado L, Stepanov I, Brinkman MC, Lee DN, Davis AK, Wagener TL. Changes in preferred e-cigarette flavor, nicotine concentration, wattage and air valve settings and cigarette consumption during a switching trial. Addiction. 2026 Oct 23. doi: 10.1111/add.70687. Online ahead of print.
The JameslineLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Theodore Wagener, PhD principal investigator

Ohio State Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Change From Conventional Cigarettes - Self Report (time frame: Week 4, Week 8, Week 12, Week 26, and Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03113136, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.