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Recruiting NCT06260683

A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior

No phase Interventional Cigarette Smoking-Related Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nicotine Replacement, Questionnaire Administration, Vaping, Vaping.
Who it may be relevant to
Registry conditions: Cigarette Smoking-Related Carcinoma. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-Cigarettes on Smoking Behavior

Overview

This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) vs. non-tobacco flavored ECs vs. nicotine replacement therapy (patches and lozenges) on smoking behavior in current cigarette smokers. ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use and learn how ECs affect smoking behaviors and health.

Detailed description

PRIMARY OBJECTIVES:

I. Determine PEC versus vs. TEC vs. nicotine replacement therapy (NRT) on tobacco use patterns including product switching, abstinence from cigarettes, and number of cigarettes smoked.

II. Examine PEC vs. TEC vs. NRT on cigarette craving, withdrawal symptoms, and perceived nicotine dependence.

III. Examine PEC vs. TEC on product appeal and uptake, including initial trial, days used during period of product provision, and purchase and continued use after 12 weeks.

OUTLINE: Participants are randomized to 1 of 3 arms.

ARM I: Participants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage.

ARM II: Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage.

ARM III: Participants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage.

Participants in all arms participate in discussions throughout the trial.

SURVEILLANCE PHASE: Participants in all arms are followed for 12-weeks after completion of study procedures.

Interventions

  • Drug Nicotine Replacement
    Given nicotine patches and nicotine lozenges
  • Other Questionnaire Administration
    Ancillary studies
  • Device Vaping
    Given Preferred Flavor e-liquid
  • Device Vaping
    Given Tobacco flavored e-liquid

Primary outcome measures

  • 7-day point prevalence complete switching rate [Time frame: At week 14]
  • Biochemically verified 7-day point prevalence abstinence from cigarettes [Time frame: At week 14]
  • Cigarettes smoked per day [Time frame: At week 14]
Secondary outcome measures (7)
  • Change in cigarettes smoked per day [Time frame: From baseline to 26 weeks]
  • Change in nicotine dependence [Time frame: From baseline to 14 weeks]
  • Changes in cigarette craving and nicotine withdrawal [Time frame: At baseline, 2, 6, 14, and 26 weeks]
  • Number of days used in past week [Time frame: At 2, 6, and 14 weeks]
  • Number of days used in past month [Time frame: At 6 and 14 weeks]
  • Product appeal [Time frame: At 2, 6, 14, and 26 weeks]
  • Continued use of ECs [Time frame: From 14 to 26 weeks]

Eligibility criteria

Inclusion criteria

  • >= 21 years old
  • Smoke >= 5 cigarettes per day for the past year
  • Willing to use either an EC or NRT
  • Read and speak English
  • Have a smartphone

Exclusion criteria

  • Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation
  • Current use of an EC > 4 days a month
  • Diagnosed medical conditions of lung disease, asthma, cystic fibrosis, heart disease or chronic obstructive pulmonary disease (COPD)
  • Unmanaged (unmedicated and/or without counseling) diagnosis of schizophrenia
  • History of cardiac event or distress within the past 3 months
  • Currently pregnant, planning to become pregnant within 6 months, or breastfeeding
  • High blood pressure not controlled by medications
  • Serious angina pectoris or chest pain
  • Stroke within the past three months
  • Known allergy to propylene glycol or vegetable glycerin
  • Serious underlying arrhythmias, irregular heartbeat or abnormal heart rhythm
  • Live in same household as another study participant

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT06260683 · OSU-22240 · NCI-2023-04102 · R01DA057327

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗