Examination of Low Wattage and High Wattage E-Cigarettes

NCT03113136 | Completed Results

• 3 other identifiers: OSU-19095R01CA204891-01NCI-2019-01855
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Week 4, Week 8, Week 12, Week 26, and Week 52

Secondary Outcomes (14)

• Cigarette Dependence

  Baseline, Week 1, Week 4, Week 8, Week 12, Week 26 and Week 52

• Cigarette Likeability/Preference

  Baseline, Week 4, Week 12, Week 26, and Week 52

• EC Likeability/Preference

  Week 4, Week 12

• EC Abuse Liability

  Week 4, Week 12, Week 26, and Week 52

• Biomarker of Exposure - NNAL

  Baseline, Week 4, Week 12

Study Arms (3)

Low wattage E cigarette device

ACTIVE COMPARATOR

Behavioral: Low wattage E cigarette device

High wattage E cigarette device

ACTIVE COMPARATOR

Behavioral: High wattage E cigarette device

Usual brand cigarette

ACTIVE COMPARATOR

Behavioral: Usual brand cigarette

Interventions

Low wattage E cigarette device BEHAVIORAL

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.

Low wattage E cigarette device

High wattage E cigarette device BEHAVIORAL

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.

High wattage E cigarette device

Usual brand cigarette BEHAVIORAL

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.

Usual brand cigarette

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• \<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).

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• University of Minnesota: collaborator

Study Sites (1)

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43214, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Cigarette Smoking; Tobacco Smoking; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Theodore L. Wagener
• Organization: OhioSUCCC

Theodore.Wagener@osumc.edu

614-366-4265

Study Officials

• Theodore Wagener, PhD

  Ohio State Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 13, 2017
• Study Start: June 29, 2017
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: April 17, 2026
• Results First Posted: February 9, 2024

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)