Tobacco UseNCT05525078
Quit or Switch: E-cigarette Study
A study testing e-cigarette and Nicotine patch, Nicotine lozenge in people with Tobacco Use, run by Medical University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tobacco Use
- What is being tested?
- e-cigarette and Nicotine patch, Nicotine lozenge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 17 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 21 years old
- Smoking at least 5 cigarettes per day for 1 year
- A quit attempt using an FDA-approved pharmacotherapy in the past year that resulted in abstinence of at least 24 hours
- Intention to quit smoking within the next month
- Access to daily e-mail or a smartphone that receives text messages
Who cannot join
- use of non-cigarette tobacco products in the past 30 days
- current use of pharmacotherapy for smoking cessation
- pregnant, breastfeeding, or trying to become pregnant
- household member currently enrolled in the study
- contraindicated for NRT
- planning to move out of the area within the next 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: E-cigarettes as Harm Reduction Tools in Smokers Who Fail to Quit With Traditional Methods
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.
- Conditions
- Tobacco Use
- Being tested
- e-cigarette, Nicotine patch, Nicotine lozenge
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-cigaretteBehavioural
Participants will select a Target Switch on which they will stop smoking cigarettes and switch entirely to the e-cigarette product.
Nicotine patch, Nicotine lozengeOther
Participants will select a Target Quit Date on which they will stop smoking, using the patches and lozenges provided.
| Study group | Role | What they receive |
|---|---|---|
| Switch Group | Experimental | Participants in the Switch group will receive a 5-week supply of e-cigarettes. Receives: Behavioral: e-cigarette |
| Meds Group | Active comparator | Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge). Receives: Other: Nicotine patch, Nicotine lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 0 through day 35
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
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Aug 2022
- Primary completion17 Jul 2023
- Study completion17 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracy Smith, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525078
- Sponsor's protocol ID
- PRO#00118102
- Status last verified
- Nov 2023
- First submitted
- 30 Aug 2022
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-cigarettes as Harm Reduction Tools in Smokers Who Fail to Quit With Traditional Methods
- ClinicalTrials.gov ID
- NCT05525078
- Acronym / sponsor ID
- PRO#00118102
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 17 Jul 2023 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Posted 26 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Switch Group | Experimental | Behavioral: e-cigaretteParticipants in the Switch group will receive a 5-week supply of e-cigarettes. |
| Meds Group | Active comparator | Other: Nicotine patch, Nicotine lozengeParticipants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 21 years old
- Smoking at least 5 cigarettes per day for 1 year
- A quit attempt using an FDA-approved pharmacotherapy in the past year that resulted in abstinence of at least 24 hours
- Intention to quit smoking within the next month
- Access to daily e-mail or a smartphone that receives text messages
Key exclusion criteria (6 listed)
- use of non-cigarette tobacco products in the past 30 days
- current use of pharmacotherapy for smoking cessation
- pregnant, breastfeeding, or trying to become pregnant
- household member currently enrolled in the study
- contraindicated for NRT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-cigaretteParticipants will select a Target Switch on which they will stop smoking cigarettes and switch entirely to the e-cigarette product. | Behavioural | Switch Group |
| Nicotine patch, Nicotine lozengeParticipants will select a Target Quit Date on which they will stop smoking, using the patches and lozenges provided. | Other | Meds Group |
Primary outcome
Percentage of Participants Who Report Daily Use of E-cigarettes or NRT and no Cigarette Use
Time frame: day 0 through day 35
daily use of e-cigarette or NRT instead of cigarettes
Percentage of Participants Who Have Biochemically-confirmed Abstinence From Cigarette Smoking at Week 4
Time frame: Week 4
Self reported point prevalence abstinence from cigarettes and expired carbon monoxide < 6 ppm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-cigarette and Nicotine patch, Nicotine lozenge in people with Tobacco Use, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Report Daily Use of E-cigarettes or NRT and no Cigarette Use (time frame: day 0 through day 35). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.