Examination of Low Wattage and High Wattage E-Cigarettes

Not Applicable

Completed

Conditions: Smoking, Tobacco
Exposure to Toxic Agent
Nicotine Dependence
Smoking, Cigarette

Interventions: Behavioral: High wattage E cigarette device
Behavioral: Low wattage E cigarette device
Behavioral: Usual brand cigarette

Registration Number: NCT03113136

Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 372

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High wattage E cigarette device	High wattage E cigarette device	-
Low wattage E cigarette device	Low wattage E cigarette device	-
Usual brand cigarette	Usual brand cigarette	-

Primary Outcome Measures

Name	Time	Method
Complete Change From Conventional Cigarettes - Self Report	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.
Complete Change From Conventional Cigarettes - Biochemically Verified	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 Outcome Measures

Name	Time	Method
Biomarker of Exposure - NNAL	Baseline, Week 4, Week 12	Urinary total 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanol \[NNAL\] (ng/g creatinine)
Biomarker of Exposure - Total Nicotine Equivalents (TNE)	Baseline, Week 4, Week 12	Sum of nicotine and metabolites in urine
Cigarette Dependence	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.
EC Likeability/Preference	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.
EC Abuse Liability	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.
Cigarette Likeability/Preference	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
Biomarker of Exposure - NNN	Baseline, Week 4, Week 12	Presence of urinary \[pyridine-D4\]NNN (\[D4\]NNN)
Biomarker of Exposure - Nicotine Metabolite Ratio	Baseline, Week 4, Week 12	Biomarker of nicotine clearance formed using the ratio of 2 nicotine metabolites (3'hydroxycotinine \[3HC\]/cotinine)
Biomarker of Exposure - Nickel and Other Relevant Metals	Baseline, Week 4, Week 12	Metals and metalloids in saliva
Biomarker of Exposure - 8-iso-PGF2a	Baseline, Week 4, Week 12	Urinary biomarker of oxidative stress and inflammation
Biomarker of Exposure - Lead and Other Relevant Metals	Baseline, Week 4, Week 12	Metals and metalloids in saliva
Biomarker of Exposure - PGEM	Baseline, Week 4, Week 12	Urinary biomarker of oxidative stress and inflammation
Biomarker of Effect - q-PADDA	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.
Biomarker of Exposure - Cadmium and Other Relevant Metals	Baseline, Week 4, Week 12	Metals and metalloids in saliva