Status:
RECRUITING
A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cigarette Smoking-Related Carcinoma
Eligibility:
All Genders
21+ years
Phase:
NA
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...
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 sm...
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
Key Trial Info
Start Date :
April 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 12 2028
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06260683
Start Date
April 10 2024
End Date
April 12 2028
Last Update
April 6 2026
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210