SmokingNCT04238832
Salt-Based E-cigarette
A study testing Salt Base Nicotine and Free Base Nicotine in people with Smoking and Tobacco Use, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Electronic nicotine delivery systems (ENDS) vary on a wide range of characteristics, which may impact the reinforcement value of the products compared to more harmful combustible products. A new type of low-powered ENDS device has surged in popularity-the pod system. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco Use
- What is being tested?
- Salt Base Nicotine and Free Base Nicotine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2020to 23 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- daily cigarette smoker
- interested in using non-cigarette tobacco product
- have a smartphone that can receive text messages and has access to the internet or have an e-mail account they check daily (necessary for daily diary completion).
Who cannot join
- additional tobacco use criteria
- additional medical criteria
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: Impact of Non-Cigarette Tobacco Product Formulation on Reinforcement Value and Use in Current Smokers
Electronic nicotine delivery systems (ENDS) vary on a wide range of characteristics, which may impact the reinforcement value of the products compared to more harmful combustible products. A new type of low-powered ENDS device has surged in popularity-the pod system. Pods use nicotine salt e-liquids, rather than free-base nicotine solutions that have been used in other ENDS device types. Manufacturers claim that these formulations reduce the harshness of nicotine delivery, while still delivering sufficiently high levels of nicotine. However, the role of nicotine salts in the popularity and use of pod systems remains unclear because no studies have directly manipulated and examined the role of nicotine formulation (salt vs. free base) in reinforcement value and use. The primary purpose of the proposed study is to assess the impact of nicotine formulation (nicotine salt vs. free-base) in reinforcement value and tobacco use. Current smokers (n=30) will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit during which they will sample a traditional cigarette and two ENDS products (nicotine salt ENDS, free base ENDS). All aspects of the device will be held constant other than the nicotine formulation (including nicotine concentration, flavor options, device brand). Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the products they sampled and their own cigarette. Finally, participants will be assigned to take one of the products they sampled home to use ad libitum (1-week sampling). During the at-home baseline and sampling weeks, participants will complete electronic daily diaries cataloging their tobacco use. Biomarkers (i.e., expired carbon monoxide, cotinine) will corroborate self-reported indices of use.
- Conditions
- Smoking, Tobacco Use
- Being tested
- Salt Base Nicotine, Free Base Nicotine
- Medical subject headings
- Smoking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt Base NicotineOther
Participants will try both free base and salt base nicotine e-liquid and then take home salt base nicotine
Free Base NicotineOther
Participants will try both free base and salt base nicotine e-liquid and then take home free base nicotine
| Study group | Role | What they receive |
|---|---|---|
| Free Base Nicotine | Active comparator | Participants assigned to this group will try both a free base nicotine and a salt base nicotine, and then take home an e-cigarette and free base nicotine e-liquid to sample for one week. Receives: Other: Free Base Nicotine |
| Salt Base Nicotine | Active comparator | Participants assigned to this group will try both a free base nicotine and a salt base nicotine, and then take home an e-cigarette and salt base nicotine e-liquid to sample for one week. Receives: Other: Salt Base Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Most preferred product
Participants complete a preference assessment in which they choose between the salt liquid, free base liquid, or a traditional cigarette in a series of trials. The outcome of this assessment is the product chosen most often by each participant.
Measured: Lab Visit 2, occurring approximately one week after the initial screening/baseline visit
Secondary outcomes (1)
Cigarettes per day
The average number of cigarettes smoked per day during the one week sampling period
Measured: Week 2 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start16 Jun 2020
- Primary completion9 Jul 2021
- Study completion23 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT04238832
- Sponsor's protocol ID
- Pro00093724
- Status last verified
- Aug 2021
- First submitted
- 17 Jan 2020
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-Cigarette Tobacco Product Formulation on Reinforcement Value and Use in Current Smokers
- ClinicalTrials.gov ID
- NCT04238832
- Acronym / sponsor ID
- Pro00093724
- Conditions
- Smoking, Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 23 Jul 2021 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electronic nicotine delivery systems (ENDS) vary on a wide range of characteristics, which may impact the reinforcement value of the products compared to more harmful combustible products. A new type of low-powered ENDS device has surged in popularity-the pod system. Pods use nicotine salt e-liquids, rather than free-base nicotine solutions that have been used in other ENDS device types. Manufacturers claim that these formulations reduce the harshness of nicotine delivery, while still delivering sufficiently high levels of nicotine. However, the role of nicotine salts in the popularity and use of pod systems remains unclear because no studies have directly manipulated and examined the role of nicotine formulation (salt vs. free base) in reinforcement value and use. The primary purpose of the proposed study is to assess the impact of nicotine formulation (nicotine salt vs. free-base) in reinforcement value and tobacco use. Current smokers (n=30) will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit during which they will sample a traditional cigarette and two ENDS products (nicotine salt ENDS, free base ENDS). All aspects of the device will be held constant other than the nicotine formulation (including nicotine concentration, flavor options, device brand). Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the products they sampled and their own cigarette. Finally, participants will be assigned to take one of the products they sampled home to use ad libitum (1-week sampling). During the at-home baseline and sampling weeks, participants will complete electronic daily diaries cataloging their tobacco use. Biomarkers (i.e., expired carbon monoxide, cotinine) will corroborate self-reported indices of use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free Base Nicotine | Active comparator | Other: Free Base NicotineParticipants assigned to this group will try both a free base nicotine and a salt base nicotine, and then take home an e-cigarette and free base nicotine e-liquid to sample for one week. |
| Salt Base Nicotine | Active comparator | Other: Salt Base NicotineParticipants assigned to this group will try both a free base nicotine and a salt base nicotine, and then take home an e-cigarette and salt base nicotine e-liquid to sample for one week. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- daily cigarette smoker
- interested in using non-cigarette tobacco product
- have a smartphone that can receive text messages and has access to the internet or have an e-mail account they check daily (necessary for daily diary completion).
Key exclusion criteria (2 listed)
- additional tobacco use criteria
- additional medical criteria
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 |
|---|---|---|
| Salt Base NicotineParticipants will try both free base and salt base nicotine e-liquid and then take home salt base nicotine | Other | Salt Base Nicotine |
| Free Base NicotineParticipants will try both free base and salt base nicotine e-liquid and then take home free base nicotine | Other | Free Base Nicotine |
Primary outcome
Most preferred product
Time frame: Lab Visit 2, occurring approximately one week after the initial screening/baseline visit
Participants complete a preference assessment in which they choose between the salt liquid, free base liquid, or a traditional cigarette in a series of trials. The outcome of this assessment is the product chosen most often by each participant.
1 secondary outcome
Cigarettes per day
Time frame: Week 2 of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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 Salt Base Nicotine and Free Base Nicotine in people with Smoking and 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 3 inclusion and 2 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 9 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Most preferred product (time frame: Lab Visit 2, occurring approximately one week after the initial screening/baseline visit). 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 9 Aug 2021; AzTrials last refreshed its copy on 27 Oct 2026.