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Completed

NCT Number: NCT03113136

Examination of Low Wattage and High Wattage E-Cigarettes

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.

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Key information

Conditions

Smoking, Cigarette Behavior Chemically-Induced Disorders Cigarette Smoking Exposure to Toxic Agent Mental Disorders Nicotine Dependence Smoking Smoking, Tobacco Substance-Related Disorders Tobacco Smoking Tobacco Use Tobacco Use Disorder

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43214, United States

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;
  • 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. -

Exclusion criteria

  • <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).

-

Treatment and study plan

Low wattage E cigarette device

Behavioral

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 device

Behavioral

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 cigarette

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. Biomarker of Exposure - NNAL

    Time frame: Baseline, Week 4, Week 12

    Urinary total 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanol [NNAL] (pmol/mg creatinine)

  6. Biomarker of Exposure - NNN

    Time frame: Baseline, Week 4, Week 12

    Presence of urinary [pyridine-D4]NNN ([D4]NNN) (pmol/mg creatinine)

  7. 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)

  8. Biomarker of Exposure - Nickel

    Time frame: Baseline, Week 4, Week 12

    Metals and metalloids in saliva - Nickel (ng/mL)

  9. Biomarker of Exposure - Cadmium

    Time frame: Baseline, Week 4, Week 12

    Metals and metalloids in saliva - Cadmium (ng/mL)

  10. Biomarker of Exposure - Lead

    Time frame: Baseline, Week 4, Week 12

    Metals and metalloids in saliva - Lead (ng/mL)

  11. 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)

  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.

  13. 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)

  14. Biomarker of Exposure - PGEM

    Time frame: Baseline, Week 4, Week 12

    Urinary biomarker of oxidative stress and inflammation

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

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

Registry information

Acronym: SWITCH

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Apr 13, 2017
Registry last updated
Apr 17, 2026

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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