Clinical trial NCT06260683: A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior
Official title: A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-Cigarettes on Smoking Behavior
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-02-15
Enrollment: 1500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 7-day point prevalence complete switching rate
timeFrame: At week 14
measure: Biochemically verified 7-day point prevalence abstinence from cigarettes
timeFrame: At week 14
measure: Cigarettes smoked per day
timeFrame: At week 14
Secondary outcomes:
measure: Change in cigarettes smoked per day
timeFrame: From baseline to 26 weeks
measure: Change in nicotine dependence
timeFrame: From baseline to 14 weeks
measure: Changes in cigarette craving and nicotine withdrawal
timeFrame: At baseline, 2, 6, 14, and 26 weeks
measure: Number of days used in past week
timeFrame: At 2, 6, and 14 weeks
measure: Number of days used in past month
timeFrame: At 6 and 14 weeks
measure: Product appeal
timeFrame: At 2, 6, 14, and 26 weeks
measure: Continued use of ECs
timeFrame: From 14 to 26 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Theodore L Wagener, PhD
role: PRINCIPAL_INVESTIGATOR
References: