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Quit or Switch: E-cigarette Study

E-cigarettes as Harm Reduction Tools in Smokers Who Fail to Quit With Traditional Methods

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05525078
Enrollment
30
Registered
2022-09-01
Start date
2022-08-01
Completion date
2023-07-17
Last updated
2024-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use

Brief 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.

Interventions

BEHAVIORALe-cigarette

Participants will select a Target Switch on which they will stop smoking cigarettes and switch entirely to the e-cigarette product.

OTHERNicotine patch, Nicotine lozenge

Participants will select a Target Quit Date on which they will stop smoking, using the patches and lozenges provided.

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. At least 21 years old 2. Smoking at least 5 cigarettes per day for 1 year 3. A quit attempt using an FDA-approved pharmacotherapy in the past year that resulted in abstinence of at least 24 hours 4. Intention to quit smoking within the next month 5. Access to daily e-mail or a smartphone that receives text messages

Exclusion criteria

1. use of non-cigarette tobacco products in the past 30 days 2. current use of pharmacotherapy for smoking cessation 3. pregnant, breastfeeding, or trying to become pregnant 4. household member currently enrolled in the study 5. contraindicated for NRT 6. planning to move out of the area within the next 6 months.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Who Report Daily Use of E-cigarettes or NRT and no Cigarette Useday 0 through day 35daily use of e-cigarette or NRT instead of cigarettes
Percentage of Participants Who Have Biochemically-confirmed Abstinence From Cigarette Smoking at Week 4Week 4Self reported point prevalence abstinence from cigarettes and expired carbon monoxide \< 6 ppm

Countries

United States

Participant flow

Participants by arm

ArmCount
Switch Group
Participants in the Switch group will receive a 5-week supply of e-cigarettes. e-cigarette: Participants will select a Target Switch on which they will stop smoking cigarettes and switch entirely to the e-cigarette product.
20
Meds Group
Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge). Nicotine patch, Nicotine lozenge: Participants will select a Target Quit Date on which they will stop smoking, using the patches and lozenges provided.
10
Total30

Baseline characteristics

CharacteristicSwitch GroupTotalMeds Group
Age, Continuous50.8 years
STANDARD_DEVIATION 12.8
50.4 years
STANDARD_DEVIATION 11.9
49.6 years
STANDARD_DEVIATION 10.3
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants30 Participants10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
3 Participants3 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
17 Participants26 Participants9 Participants
Region of Enrollment
United States
20 Participants30 Participants10 Participants
Sex: Female, Male
Female
11 Participants17 Participants6 Participants
Sex: Female, Male
Male
9 Participants13 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 10
other
Total, other adverse events
8 / 2010 / 10
serious
Total, serious adverse events
0 / 201 / 10

Outcome results

Primary

Percentage of Participants Who Have Biochemically-confirmed Abstinence From Cigarette Smoking at Week 4

Self reported point prevalence abstinence from cigarettes and expired carbon monoxide \< 6 ppm

Time frame: Week 4

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Switch GroupPercentage of Participants Who Have Biochemically-confirmed Abstinence From Cigarette Smoking at Week 47 Participants
Meds GroupPercentage of Participants Who Have Biochemically-confirmed Abstinence From Cigarette Smoking at Week 41 Participants
Primary

Percentage of Participants Who Report Daily Use of E-cigarettes or NRT and no Cigarette Use

daily use of e-cigarette or NRT instead of cigarettes

Time frame: day 0 through day 35

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026