N/A
N=372
Examination of Low Wattage and High Wattage E-Cigarettes
Smoking, Cigarette · Smoking, Tobacco · Nicotine Dependence · Exposure to Toxic Agent
Bottom Line
View on ClinicalTrials.gov: NCT03113136 ↗Enrolled (actual)
372
Serious AEs
1.9%
Results posted
Feb 2024
Primary outcome: Primary: Complete Change From Conventional Cigarettes - Self Report — 0; 12; 10; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low wattage E cigarette device (Behavioral); High wattage E cigarette device (Behavioral); Usual brand cigarette (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Change From Conventional Cigarettes - Self Report |
0; 12; 10; 0; 19; 10 | — |
| PRIMARY Complete Change From Conventional Cigarettes - Biochemically Verified |
0; 10; 9; 0; 16; 8 | — |
| SECONDARY Cigarette Dependence |
48.27; 47.63; 47.45; 48.45; 43.71; 43.33 | — |
| SECONDARY Cigarette Likeability/Preference |
4.68; 5.01; 4.81; 4.30; 4.54; 4.13 | — |
| SECONDARY EC Likeability/Preference |
4.67; 4.63; 2.93; 2.61; 1.48; 1.50 | — |
| SECONDARY EC Abuse Liability |
72.08; 61.87; 60.43; 78.95; 67.78; 69.44 | — |
| SECONDARY Biomarker of Exposure - NNAL |
3.27; 3.13; 3.20; 3.09; 2.21; 2.98 | — |
| SECONDARY Biomarker of Exposure - NNN |
0.07; 0.06; 0.07; 0.06; 0.03; 0.09 | — |
| SECONDARY Biomarker of Exposure - Total Nicotine Equivalents (TNE) |
74.61; 70.18; 69.95; 77.57; 63.85; 73.44 | — |
| SECONDARY Biomarker of Exposure - Nickel |
13.31; 15.59; 27.44; 17.91; 14.75; 19.69 | — |
| SECONDARY Biomarker of Exposure - Cadmium |
0.25; 0.34; 0.36; 0.33; 0.20; 0.26 | — |
| SECONDARY Biomarker of Exposure - Lead |
0.67; 0.56; 1.13; 0.94; 0.54; 0.63 | — |
| SECONDARY Biomarker of Exposure - 8-iso-PGF2a |
1.41; 1.66; 1.18; 1.49; 1.73; 4.68 | — |
| SECONDARY Biomarker of Effect - q-PADDA |
1.14; -4.30; -3.37; -0.10; -5.40; -4.10 | — |
| SECONDARY Biomarker of Exposure - Nicotine Metabolite Ratio |
— | — |
| SECONDARY Biomarker of Exposure - PGEM |
— | — |
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
- 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).
-
Data sourced from ClinicalTrials.gov (NCT03113136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.