Medical University of South Carolina, Charleston, SC
e-cigarette - Behavioral
You have a chance of qualifying for this trial. We made sure your application will take less than 5 minutes.
What conditions do you have?
What conditions do you have?
The majority of smokers try to quit each year, and the majority of quit attempts fail, even when the most effective FDA-approved pharmacotherapies are used. Non-combustible tobacco products emit fewer harmful chemicals than cigarettes, and thus for smokers who cannot quit smoking, switching completely to a less harmful product is likely to improve their risk of cancer and other deleterious health outcomes. E-cigarettes, the most commonly used non-cigarette tobacco product, have been shown to deliver sufficient nicotine, be appealing to smokers, and reduce cigarette smoking when provided to smokers to use ad libitum. For smokers who have failed to quit with traditional methods, trying to switch to a less harmful product may be more likely to help them stop smoking than trying to quit using tobacco altogether repeatedly with pharmacotherapy. The proposed trial evaluates the potential of e-cigarettes to serve as harm reduction tools for current smokers who have already tried, and failed, to quit with traditional methods. Current smokers who failed to quit with FDA-approved pharmacotherapy within the past year (N=30) will be randomly assigned to either 1) switch completely to e-cigarettes (Switch Group, n=20), or 2) try to quit again using pharmacotherapy (Meds Group, n=10). Thus, our design is strengthened by a strong active control group. Participants will select a Target Switch / Quit Date on which they will stop smoking. Participants in the Switch group will receive a 5-week supply of JUUL e-cigarettes, the most popular e-cigarette currently available. Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge). Participants will use 1-week of their tobacco product or medication ad libitum while continuing to smoke in advance of their Target Switch / Quit Date, and 4-weeks as instructed following a Target Switch or Quit Date. Behavioral outcomes of interest include smoking reduction > 50% and biochemically-confirmed abstinence from cigarette smoking at 4-weeks. The proposed trial addresses a highly significant research question using a rigorous design and is supported by a strong investigative team.
This histogram enumerates side effects from a completed 2021 Phase 2 & 3 trial (NCT04210180) in the Varenicline Plus E-cigarette ARM group. Side effects include: Nausea with 40%, Headache with 24%, Cough with 20%, Insomnia with 16%, Nightmares/ Vivid Dreams with 12%.
2 Treatment Groups
1 of 2
1 of 2
30 Total Participants · 2 Treatment Groups
Primary Treatment: e-cigarette · No Placebo Group · N/A
Experimental Group · 1 Intervention: e-cigarette · Intervention Types: Behavioral
ActiveComparator Group · 1 Intervention: Nicotine patch, Nicotine lozenge · Intervention Types: Drug
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3
Screening: ~3 weeks
Reporting: day 0 through day 35
Closest Location: Medical University of South Carolina · Charleston, SC
1993First Recorded Clinical Trial
7 TrialsResearching Tobacco Use
1235 CompletedClinical Trials
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
828 Previous Clinical Trials
5,371,823 Total Patients Enrolled
8 Trials studying Tobacco Use
42,398 Patients Enrolled for Tobacco Use
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:
You are 21 or older.
You smoke at least 5 cigarettes per day for 1 year.
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.