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

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06260683
• Other study ID #: OSU-22240
• Secondary ID: NCI-2023-04102R0
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 29, 2024
• Est. completion date: April 29, 2027

Study information

• Verified date: April 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: April 29, 2027
• Est. primary completion date: April 29, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking-Related Carcinoma

Intervention

Drug:
• Nicotine Replacement
Given nicotine patches and nicotine lozenges

Other:
• Questionnaire Administration
Ancillary studies

Device:
• Vaping
Given Preferred Flavor e-liquid
• Vaping
Given Tobacco flavored e-liquid

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Switching rate	Complete switching rate will be assessed in the preferred flavor EC (PEC) and tobacco flavor EC (TEC) arms.	At week 14
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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