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

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: Completed
• Conditions: Nicotine Dependence; Smoking, Tobacco; Smoking, Cigarette; Exposure to Toxic Agent
• Intervention / Treatment: Behavioral: Low wattage E cigarette device; Behavioral: Usual brand cigarette; Behavioral: High wattage E cigarette device

• Study Type: Interventional
• Enrollment (Actual): 372
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43214
      • The Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• 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).

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	Week 4, Week 8, Week 12, Week 26, and Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cigarette Dependence	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	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	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	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	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	Urinary biomarker of oxidative stress and inflammation	Baseline, Week 4, Week 12
Biomarker of Exposure - NNAL	Urinary total 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanol [NNAL] (pmol/mg creatinine)	Baseline, Week 4, Week 12
Biomarker of Exposure - NNN	Presence of urinary [pyridine-D4]NNN ([D4]NNN) (pmol/mg creatinine)	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)	Baseline, Week 4, Week 12
Biomarker of Exposure - Nickel	Metals and metalloids in saliva - Nickel (ng/mL)	Baseline, Week 4, Week 12
Biomarker of Exposure - Cadmium	Metals and metalloids in saliva - Cadmium (ng/mL)	Baseline, Week 4, Week 12
Biomarker of Exposure - Lead	Metals and metalloids in saliva - Lead (ng/mL)	Baseline, Week 4, Week 12
Biomarker of Exposure - 8-iso-PGF2a	Urinary biomarker of oxidative stress and inflammation - 8-iso-PGF2a (pmol/mg creatinine)	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.	Week 4, Week 12

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH); University of Minnesota
• Investigators: Principal Investigator: Theodore Wagener, PhD, Ohio State Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2017
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Smoking; Tobacco Use; Tobacco Use Disorder; Cigarette Smoking; Tobacco Smoking
• Other Study ID 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