Examination of Low Wattage and High Wattage E-Cigarettes

Nicotine Dependence Clinical Trial

— SWITCH  

Official title:

Examination of Low Wattage and High Wattage E-Cigarettes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113136
• Other study ID #: OSU-19095
• Secondary ID: R01CA204891-01NC
• Status: Completed
• Phase: N/A
• Start date: June 29, 2017
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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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Related Conditions & MeSH terms

• Exposure to Toxic Agent
• Nicotine Dependence
• Smoking, Cigarette
• Smoking, Tobacco
• Tobacco Use Disorder

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI), National Institutes of Health (NIH), University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Biomarker of Exposure - NNAL	Urinary total 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanol [NNAL] (ng/g creatinine)	Baseline, Week 4, Week 12
Secondary	Biomarker of Exposure - NNN	Presence of urinary [pyridine-D4]NNN ([D4]NNN)	Baseline, Week 4, Week 12
Secondary	Biomarker of Exposure - Total Nicotine Equivalents (TNE)	Sum of nicotine and metabolites in urine	Baseline, Week 4, Week 12
Secondary	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
Secondary	Biomarker of Exposure - Nickel and Other Relevant Metals	Metals and metalloids in saliva	Baseline, Week 4, Week 12
Secondary	Biomarker of Exposure - Cadmium and Other Relevant Metals	Metals and metalloids in saliva	Baseline, Week 4, Week 12
Secondary	Biomarker of Exposure - Lead and Other Relevant Metals	Metals and metalloids in saliva	Baseline, Week 4, Week 12
Secondary	Biomarker of Exposure - 8-iso-PGF2a	Urinary biomarker of oxidative stress and inflammation	Baseline, Week 4, Week 12
Secondary	Biomarker of Exposure - PGEM	Urinary biomarker of oxidative stress and inflammation	Baseline, Week 4, Week 12
Secondary	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.	Week 4, Week 12

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