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NCT Number: NCT06260683

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

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.

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Key information

Conditions

Cigarette Smoking-Related Carcinoma

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Theodore L. Wagener, PhD

CONTACT

[email protected]

Theodore L. Wagener, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine Replacement

Drug

Given nicotine patches and nicotine lozenges

Other names: Nicotine Replacement Therapy, NRT

Questionnaire Administration

Other

Ancillary studies

Vaping

Device

Given Preferred Flavor e-liquid

Other names: Vape

Primary outcomes

  1. 7-day point prevalence complete switching rate

    Time frame: At week 14

    Self-reported 7-day point prevalence abstinence (no cigarettes, not even a puff, in the previous 7 days), any reported use of ECs or NRT over the past 7 days, and an exhaled CO reading of ≤6ppm.

  2. Biochemically verified 7-day point prevalence abstinence from cigarettes

    Time frame: At week 14

    Biochemical verification of abstinence from cigarettes (exhaled CO reading of ≤6ppm) combined with self-reported 7-day point prevalence abstinence (no cigarettes, not even a puff, in the previous 7 days).

  3. Cigarettes smoked per day

    Time frame: At week 14

    Cigarettes smoked per day as evaluated with the timeline follow-back questionnaire.

Secondary outcomes

  1. Change in cigarettes smoked per day

    Time frame: From baseline to 26 weeks

    Changes in cigarettes smoked per day from baseline to 26 weeks will be evaluated with the timeline follow-back questionnaire.

  2. Change in nicotine dependence

    Time frame: From baseline to 14 weeks

    Among participants abstaining from smoking, changes in nicotine dependence from baseline to 14 weeks will be assessed in the PEC, TEC, and NRT arms with the PROMIS nicotine dependence scale. Scores range from 0 to 16 with higher scores indicating greater dependence.

  3. Changes in cigarette craving and nicotine withdrawal

    Time frame: At baseline, 2, 6, 14, and 26 weeks

    Cigarette craving and nicotine withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS). Total MPSS scores range from 12 to 60 with higher scores indicating a greater severity of tobacco withdrawal symptoms.

  4. Number of days used in past week

    Time frame: At 2, 6, and 14 weeks

    The number of days the study products are used in the past 7 days during the period of product provision in the PEC and TEC arms.

  5. Number of days used in past month

    Time frame: At 6 and 14 weeks

    The number of days the study products are used in the past 30 days during the period of product provision in the PEC and TEC arms.

  6. Product appeal

    Time frame: At 2, 6, 14, and 26 weeks

    EC appeal is measured with the modified Cigarette Evaluation Questionnaire (mCEQ) to assess subjected responses to ECs (e.g., reward, satisfaction).

  7. Continued use of ECs

    Time frame: From 14 to 26 weeks

    The proportion of participants who continue to use ECs between 14 and 26 weeks in the PEC and TEC arms.

Study contacts

Contact information is provided by the study sponsor or research team.

The Ohio State Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 15, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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