Back to resultsExamination of Low Wattage and High Wattage E-Cigarettes (SWITCH)
Primary Purpose
Smoking, Cigarette, Smoking, Tobacco, Nicotine Dependence
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low wattage E cigarette device
HIgh wattage E cigarette device
Usual brand cigarette
Sponsored by
About this trial
This is an interventional basic science trial for Smoking, Cigarette
Eligibility Criteria
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).
-
Sites / Locations
- The Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Low wattage E cigarette device
High wattage E cigarette device
Usual brand cigarette
Arm Description
Outcomes
Primary Outcome Measures
Complete change from conventional cigarettes
Timeline Follow Back Questionnaire
Complete change from conventional cigarettes
Exhaled carbon monoxide of ≤10ppm
Secondary Outcome Measures
EC Dependence
Cigarette Dependence Scale
EC Likeability/Preference
Cigarette Evaluation Scale; and EC modified-Cigarette Evaluation Scale
EC Abuse Liability
Drug Effects/Liking Questionnaire
Biomarker of Exposure - NNAL
Urinary total 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanol [NNAL] (ng/g creatinine)
Biomarker of Exposure - NNN
Presence of urinary [pyridine-D4]NNN ([D4]NNN)
Biomarker of Exposure - Total Nicotine Equivalents (TNE)
Sum of nicotine and metabolites in urine
Biomarker of Exposure - Nicotine Metabolite Ratio
Biomarker of nicotine clearance formed using the ratio of 2 nicotine metabolites (3'hydroxycotinine [3HC]/cotinine)
Biomarker of Exposure - Nickel and other relevant metals
Metals and metalloids in saliva
Biomarker of Exposure - Cadmium and other relevant metals
Metals and metalloids in saliva
Biomarker of Exposure - Lead and other relevant metals
Metals and metalloids in saliva
Biomarker of Exposure - 8-iso-PGF2a
Urinary biomarker of oxidative stress and inflammation
Biomarker of Exposure - PGEM
Urinary biomarker of oxidative stress and inflammation
Biomarker of Effect - q-PADDA
Quantifies DNA damage
Full Information
NCT ID
NCT03113136
First Posted
March 22, 2017
Last Updated
April 21, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI), University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT03113136
Brief Title
Examination of Low Wattage and High Wattage E-Cigarettes
Acronym
SWITCH
Official Title
Examination of Low Wattage and High Wattage E-Cigarettes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI), University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Cigarette, Smoking, Tobacco, Nicotine Dependence, Exposure to Toxic Agent
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low wattage E cigarette device
Arm Type
Active Comparator
Arm Title
High wattage E cigarette device
Arm Type
Active Comparator
Arm Title
Usual brand cigarette
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Low wattage E cigarette device
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HIgh wattage E cigarette device
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual brand cigarette
Intervention Description
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 Outcome Measure Information:
Title
Complete change from conventional cigarettes
Description
Timeline Follow Back Questionnaire
Time Frame
Baseline, Week1, Week 4, Week 8, Week 12, Week 26, and Week 52
Title
Complete change from conventional cigarettes
Description
Exhaled carbon monoxide of ≤10ppm
Time Frame
Baseline, Week1, Week 4, Week 8, Week 12, Week 26, and Week 52
Secondary Outcome Measure Information:
Title
EC Dependence
Description
Cigarette Dependence Scale
Time Frame
Week -1, Baseline, Week 1, Week 4, Week 8, Week 12, Week 26 and Week 52
Title
EC Likeability/Preference
Description
Cigarette Evaluation Scale; and EC modified-Cigarette Evaluation Scale
Time Frame
Baseline, Week 4, Week 12, Week 26, and Week 52
Title
EC Abuse Liability
Description
Drug Effects/Liking Questionnaire
Time Frame
Baseline, Week 4, Week 12, Week 26, and Week 52
Title
Biomarker of Exposure - NNAL
Description
Urinary total 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanol [NNAL] (ng/g creatinine)
Time Frame
Baseline, Week 4, Week 12, Week 26, and Week 52
Title
Biomarker of Exposure - NNN
Description
Presence of urinary [pyridine-D4]NNN ([D4]NNN)
Time Frame
Baseline, Week 4, Week 12, Week 26, and Week 52
Title
Biomarker of Exposure - Total Nicotine Equivalents (TNE)
Description
Sum of nicotine and metabolites in urine
Time Frame
Baseline, Week 4, Week 12, Week 26, and Week 52
Title
Biomarker of Exposure - Nicotine Metabolite Ratio
Description
Biomarker of nicotine clearance formed using the ratio of 2 nicotine metabolites (3'hydroxycotinine [3HC]/cotinine)
Time Frame
Baseline, Week 4, Week 12, Week 26, and Week 52
Title
Biomarker of Exposure - Nickel and other relevant metals
Description
Metals and metalloids in saliva
Time Frame
Baseline, Week 4, Week 12, Week 26, and Week 52
Title
Biomarker of Exposure - Cadmium and other relevant metals
Description
Metals and metalloids in saliva
Time Frame
Baseline, Week 4, Week 12, Week 26, and Week 52
Title
Biomarker of Exposure - Lead and other relevant metals
Description
Metals and metalloids in saliva
Time Frame
Baseline, Week 4, Week 12, Week 26, and Week 52
Title
Biomarker of Exposure - 8-iso-PGF2a
Description
Urinary biomarker of oxidative stress and inflammation
Time Frame
Baseline, Week 4, Week 12, Week 26, and Week 52
Title
Biomarker of Exposure - PGEM
Description
Urinary biomarker of oxidative stress and inflammation
Time Frame
Baseline, Week 4, Week 12, Week 26, and Week 52
Title
Biomarker of Effect - q-PADDA
Description
Quantifies DNA damage
Time Frame
Baseline, Week 4, Week 12, Week 26, and Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore Wagener, PhD
Organizational Affiliation
Ohio State Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline
Learn more about this trial
Examination of Low Wattage and High Wattage E-Cigarettes
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