Clinical trial NCT03113136: Examination of Low Wattage and High Wattage E-Cigarettes
Official title: Examination of Low Wattage and High Wattage E-Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Cigarette
Smoking, Tobacco
Nicotine Dependence
Exposure to Toxic Agent
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
name: University of Minnesota
First posted: 2017-04-13
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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).

   -

Primary outcomes:
measure: Complete Change From Conventional Cigarettes - Self Report
timeFrame: Week 4, Week 8, Week 12, Week 26, and Week 52
measure: Complete Change From Conventional Cigarettes - Biochemically Verified
timeFrame: Week 4, Week 8, Week 12, Week 26, and Week 52
Secondary outcomes:
measure: Cigarette Dependence
timeFrame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 26 and Week 52
measure: Cigarette Likeability/Preference
timeFrame: Baseline, Week 4, Week 12, Week 26, and Week 52
measure: EC Likeability/Preference
timeFrame: Week 4, Week 12
measure: EC Abuse Liability
timeFrame: Week 4, Week 12, Week 26, and Week 52
measure: Biomarker of Exposure - NNAL
timeFrame: Baseline, Week 4, Week 12
measure: Biomarker of Exposure - NNN
timeFrame: Baseline, Week 4, Week 12
measure: Biomarker of Exposure - Total Nicotine Equivalents (TNE)
timeFrame: Baseline, Week 4, Week 12
measure: Biomarker of Exposure - Nicotine Metabolite Ratio
timeFrame: Baseline, Week 4, Week 12
measure: Biomarker of Exposure - Nickel and Other Relevant Metals
timeFrame: Baseline, Week 4, Week 12
measure: Biomarker of Exposure - Cadmium and Other Relevant Metals
timeFrame: Baseline, Week 4, Week 12
measure: Biomarker of Exposure - Lead and Other Relevant Metals
timeFrame: Baseline, Week 4, Week 12
measure: Biomarker of Exposure - 8-iso-PGF2a
timeFrame: Baseline, Week 4, Week 12
measure: Biomarker of Exposure - PGEM
timeFrame: Baseline, Week 4, Week 12
measure: Biomarker of Effect - q-PADDA
timeFrame: Week 4, Week 12
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State Comprehensive Cancer Center
name: Theodore Wagener, PhD
role: PRINCIPAL_INVESTIGATOR
References: