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

NCT06260683 | Recruiting DMC FDA Device

• 3 other identifiers: OSU-22240NCI-2023-04102R01DA057327
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (3)

• 7-day point prevalence complete switching rate

  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.

  At week 14

• Biochemically verified 7-day point prevalence abstinence from cigarettes

  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).

  At week 14

• Cigarettes smoked per day

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

  At week 14

Secondary Outcomes (7)

• Change in cigarettes smoked per day

  From baseline to 26 weeks

• Change in nicotine dependence

  From baseline to 14 weeks

• Changes in cigarette craving and nicotine withdrawal

  At baseline, 2, 6, 14, and 26 weeks

• Number of days used in past week

  At 2, 6, and 14 weeks

• Number of days used in past month

  At 6 and 14 weeks

Study Arms (3)

Arm I (PEC)

EXPERIMENTAL

Participants receive PEC 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.

Other: Questionnaire Administration; Device: Vaping

Arm II (TEC)

EXPERIMENTAL

Participants receive TEC 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.

Other: Questionnaire Administration; Device: Vaping

Arm III (NRT)

ACTIVE COMPARATOR

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.

Drug: Nicotine Replacement; Other: Questionnaire Administration

Interventions

Nicotine Replacement DRUG

Given nicotine patches and nicotine lozenges

Also known as: Nicotine Replacement Therapy, NRT

Arm III (NRT)

Questionnaire Administration OTHER

Ancillary studies

Arm I (PEC); Arm II (TEC); Arm III (NRT)

Vaping DEVICE

Given Preferred Flavor e-liquid

Also known as: Vape

Arm I (PEC)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Interventions

Nicotine Replacement Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Theodore L Wagener, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

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

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: April 10, 2024
• Primary Completion (Estimated): April 12, 2028
• Study Completion (Estimated): April 12, 2028
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)