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

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) to non-tobacco flavored ECs on smoking behavior in current cigarette smokers to use of nicotine replacement therapy (patches and lozenges). 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Device: Vaping; Device: Vaping; Drug: Nicotine Replacement

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.

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
      • Principal Investigator: Theodore L. Wagener, PhD
      • Contact: Theodore L. Wagener, PhD; Email: Theodore.Wagener@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (PEC); 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; Ancillary studies; Device: Vaping; Given Preferred Flavor e-liquid; Other Names: Vape; Device: Vaping; Given Tobacco flavored e-liquid; Other Names: Vape
Experimental: Arm II (TEC); 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; Ancillary studies; Device: Vaping; Given Preferred Flavor e-liquid; Other Names: Vape; Device: Vaping; Given Tobacco flavored e-liquid; Other Names: Vape
Active Comparator: Arm III (NRT); 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.	Other: Questionnaire Administration; Ancillary studies; Drug: Nicotine Replacement; Given nicotine patches and nicotine lozenges; Other Names: Nicotine Replacement Therapy; NRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Switching rate	Complete switching rate will be assessed in the preferred flavor EC (PEC) and tobacco flavor EC (TEC) arms.	At week 14
Biochemically verified 7-day point prevalence abstinence from cigarettes	Biochemical verification of abstinence from cigarettes combined with self-reported use of nicotine replacement therapy (NRT) or electronic cigarette (EC) to assess complete switching. Participants reporting both 7-day point prevalence abstinence and an exhaled carbon monoxide reading less than or equal to 8 will be considered to be abstinent.	At week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cigarettes smoked per day	Changes in cigarettes smoked per day from baseline to 26 weeks will be evaluated with the timeline follow-back questionnaire.	From baseline to 26 weeks
Number of days used	The number of days the study products are used during the period of product provision in the PEC and TEC arms.	From baseline through 14 weeks
Product appeal	EC appeal is measured with the modified Cigarette Evaluation Questionnaire (mCEQ) to assess subjected responses to ECs (e.g., reward, satisfaction).	At 2, 6, 14, and 26 weeks
Continued purchase and use of ECs	The proportion of participants who continue to purchase and use ECs between 14 and 26 weeks in the PEC and TEC arms.	From 14 to 26 weeks
Change in nicotine dependence	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 cigarette dependence scale. Scores range from 12 to 60 with higher scores indicating greater dependence.	From baseline to 14 weeks
Changes in cigarette craving and nicotine withdrawal	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.	At baseline, 2, 6, 14, and 26 weeks

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Theodore L Wagener, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Estimated): April 29, 2024
• Primary Completion (Estimated): April 29, 2027
• Study Completion (Estimated): April 29, 2027

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: OSU-22240; NCI-2023-04102 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01DA057327 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No