Comparing tobacco-flavored and non-tobacco flavored e-cigarettes for smoking cessation
A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-Cigarettes on Smoking Behavior
This study tests whether tobacco-flavored e-cigarettes, non-tobacco flavored e-cigarettes, or nicotine replacement therapy can help current smokers quit smoking and manage their cravings better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06260683 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of tobacco-flavored electronic cigarettes (ECs), non-tobacco flavored ECs, and nicotine replacement therapy (NRT) on smoking behavior among current cigarette smokers. Participants will be randomized into three groups, each receiving one of the interventions for 14 weeks, with a pre-switch period to familiarize themselves with the products. The study aims to assess tobacco use patterns, cravings, withdrawal symptoms, and the appeal of the different products. Participants will also be followed for an additional 12 weeks after the intervention to monitor long-term effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who smoke at least 5 cigarettes per day and are willing to use either e-cigarettes or nicotine replacement therapy.
Not a fit: Patients who are currently using smoking cessation medications or have certain medical conditions such as lung disease or heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective smoking cessation strategies tailored to individual preferences.
How similar studies have performed: Other studies have shown varying success with e-cigarettes as cessation tools, but this specific comparison of flavors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Theodore L Wagener, PhD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.