e-cigarette for Tobacco Use

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Medical University of South Carolina, Charleston, SC
Tobacco Use
e-cigarette - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Treatment Effectiveness

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: day 0 through day 35

Day 35
Full substitution of study product
Percentage of participants who have biochemically-confirmed abstinence from cigarette smoking
Percentage of participants who report daily use of e-cigarettes or NRT and no cigarette use
biochemically-confirmed abstinence from cigarette smoking

Trial Safety

Side Effects for

Varenicline Plus E-cigarette
40%Nausea
24%Headache
20%Cough
16%Insomnia
12%Nightmares/ Vivid Dreams
8%Sore Throat
8%Vomiting
8%Constipation
8%Agitation/Anxiety
4%Allergic Reaction to lidocaine
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%.

Trial Design

2 Treatment Groups

Meds Group
1 of 2
Switch Group
1 of 2
Active Control
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: e-cigarette · No Placebo Group · N/A

Switch Group
Behavioral
Experimental Group · 1 Intervention: e-cigarette · Intervention Types: Behavioral
Meds Group
Drug
ActiveComparator Group · 1 Intervention: Nicotine patch, Nicotine lozenge · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
e-cigarette
2015
Completed Phase 3
~1720

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 0 through day 35
Closest Location: Medical University of South Carolina · Charleston, SC
Photo of medical university of south carolina 1Photo of medical university of south carolina 2Photo of medical university of south carolina 3
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

Eligibility Criteria

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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.