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

The Ohio State University

Status: Enrolling

Conditions: Cigarette Smoking-Related Carcinoma

Treatments: Other: Questionnaire Administration; Device: Vaping; Drug: Nicotine Replacement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06260683

OSU-22240

R01DA057327 (U.S. NIH Grant/Contract)

NCI-2023-04102 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 3 patient groups

Arm I (PEC)

Experimental group

Description:

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.

Treatment:

Device: Vaping

Device: Vaping

Other: Questionnaire Administration

Arm II (TEC)

Experimental group

Description:

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.

Treatment:

Device: Vaping

Device: Vaping

Other: Questionnaire Administration

Arm III (NRT)

Active Comparator group

Description:

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.

Treatment:

Drug: Nicotine Replacement

Other: Questionnaire Administration