Examination of Low Wattage and High Wattage E-Cigarettes

Ohio State University Comprehensive Cancer Center372 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

372

Conditions

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

Interventions

Low wattage E cigarette deviceBEHAVIORAL

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 deviceBEHAVIORAL

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 cigaretteBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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). \-

Locations (1)

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: Week 4, Week 8, Week 12, Week 26, and Week 52

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.

Time frame: Week 4, Week 8, Week 12, Week 26, and Week 52

Secondary Outcomes

Cigarette Dependence

Cigarette Dependence Scale Scores range from 12 to 60 with higher scores indicating greater dependence.

Time frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 26 and Week 52

Cigarette Likeability/Preference

Cigarette Evaluation Scale Scores range from 1 to 7 with higher scores indicating greater satisfaction, psychological reward, aversion, or relief

Time frame: Baseline, Week 4, Week 12, Week 26, and Week 52

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.

Time frame: Week 4, Week 12

Data from ClinicalTrials.gov

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