Examination of Low Wattage and High Wattage E-Cigarettes (SWITCH)

The Ohio State University

Status: Completed

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

Treatments: Behavioral: Low wattage E cigarette device; Behavioral: High wattage E cigarette device; Behavioral: Usual brand cigarette

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03113136

NCI-2019-01855 (Registry Identifier)

R01CA204891-01 (U.S. NIH Grant/Contract)

OSU-19095

Details and patient eligibility

About

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.

Enrollment: 372 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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372 participants in 3 patient groups

Low wattage E cigarette device

Active Comparator group

Treatment:

Behavioral: Low wattage E cigarette device

High wattage E cigarette device

Active Comparator group

Treatment:

Behavioral: High wattage E cigarette device

Usual brand cigarette

Active Comparator group

Treatment:

Behavioral: Usual brand cigarette