SmokingNCT03844672
Impact of E-cigarette Characteristics on Reinforcement and Tobacco Use Patterns
A study testing Low Power, High Power and Low Concentration in people with Smoking and Tobacco Use, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this project is to understand how different e-cigarettes influence their likeability and use among current smokers who try using e-cigarettes. Participants will receive an e-cigarette to sample over a three week period. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Smoking, Tobacco Use
- What is being tested?
- Low Power, High Power and Low Concentration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 9 Nov 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
- adults who have been smoking daily
- interested in using e-cigarettes
- who have a smartphone that can receive text messages and access to the internet or has an e-mail account that they check daily
Who cannot join
- minimal prior e-cigarette use
- use of tobacco products other than cigarettes
- current use of cessation medications
- pregnant, trying to become pregnant, or breastfeeding,
- recent history of cardiovascular distress in the last three months (e.g., arrhythmia, heart attack, stroke, uncontrolled hypertension),
- household member currently enrolled in the study.
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 E-cigarette Characteristics on Reinforcement and Tobacco Use Patterns Among
The purpose of this project is to understand how different e-cigarettes influence their likeability and use among current smokers who try using e-cigarettes. Participants will receive an e-cigarette to sample over a three week period. During this time period they will complete daily electronic diaries and weekly lab visits. The results from this information will help understand how different types of e-cigarettes are likely to influence cigarette and e-cigarette use.
- Conditions
- Smoking, Tobacco Use
- Being tested
- Low Power, High Power, Low Concentration, High Concentration
- 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.
Low PowerBehavioural
Participants will receive a low power e-cigarette to use for 3 weeks
High PowerBehavioural
Participants will receive a high power e-cigarette to use for 3 weeks
Low ConcentrationBehavioural
Participants will receive a low concentration e-liquid to use for 3 weeks
High ConcentrationBehavioural
Participants will receive a high concentration e-liquid to use for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low Concentration / Low Power | Experimental | Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks. Receives: Behavioral: Low Power; Behavioral: Low Concentration |
| Low Concentration / High Power | Experimental | Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks. Receives: Behavioral: High Power; Behavioral: Low Concentration |
| High Concentration / Low Power | Experimental | Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks. Receives: Behavioral: Low Power; Behavioral: High Concentration |
| High Concentration / High Power | Experimental | Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks. Receives: Behavioral: High Power; Behavioral: High Concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Cigarettes Per Day
Participants complete weekly surveys reporting the number of cigarettes smoked each day on a continuous scale
Measured: Week 3
Secondary outcomes (2)
Average Number of E-cigarette Puffing Episodes
Participants complete weekly surveys reporting the number of e-cigarette puffing episodes each day on a continuous scale
Measured: Week 3
Number of Choices to Smoke Cigarette in Lab Setting
Participants complete lab-based choice task at Week 3 visit in which they choose between smoking conventional cigarette and e-cigarette over 10 trials. Outcome is number of times each participant chooses to smoke conventional cigarette.
Measured: Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start1 Apr 2019
- Primary completion17 Oct 2023
- Study completion9 Nov 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 SmokingStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Tracy Smith, Medical University of South Carolina
- Investigators
- Tracy Smith, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844672
- Sponsor's protocol ID
- 00081069
- Other IDs
- K01DA047433
- Status last verified
- Oct 2024
- First submitted
- 14 Feb 2019
- Last updated
- 24 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of E-cigarette Characteristics on Reinforcement and Tobacco Use Patterns Among
- ClinicalTrials.gov ID
- NCT03844672
- Acronym / sponsor ID
- 00081069
- Conditions
- Smoking, Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Posted 24 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to understand how different e-cigarettes influence their likeability and use among current smokers who try using e-cigarettes. Participants will receive an e-cigarette to sample over a three week period. During this time period they will complete daily electronic diaries and weekly lab visits. The results from this information will help understand how different types of e-cigarettes are likely to influence cigarette and e-cigarette use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Concentration / Low Power | Experimental | Behavioral: Low Power, Behavioral: Low ConcentrationParticipant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks. |
| Low Concentration / High Power | Experimental | Behavioral: High Power, Behavioral: Low ConcentrationParticipant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks. |
| High Concentration / Low Power | Experimental | Behavioral: Low Power, Behavioral: High ConcentrationParticipant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks. |
| High Concentration / High Power | Experimental | Behavioral: High Power, Behavioral: High ConcentrationParticipant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults who have been smoking daily
- interested in using e-cigarettes
- who have a smartphone that can receive text messages and access to the internet or has an e-mail account that they check daily
Key exclusion criteria (6 listed)
- minimal prior e-cigarette use
- use of tobacco products other than cigarettes
- current use of cessation medications
- pregnant, trying to become pregnant, or breastfeeding,
- recent history of cardiovascular distress in the last three months (e.g., arrhythmia, heart attack, stroke, uncontrolled hypertension),
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 |
|---|---|---|
| Low PowerParticipants will receive a low power e-cigarette to use for 3 weeks | Behavioural | High Concentration / Low Power, Low Concentration / Low Power |
| High PowerParticipants will receive a high power e-cigarette to use for 3 weeks | Behavioural | High Concentration / High Power, Low Concentration / High Power |
| Low ConcentrationParticipants will receive a low concentration e-liquid to use for 3 weeks | Behavioural | Low Concentration / High Power, Low Concentration / Low Power |
| High ConcentrationParticipants will receive a high concentration e-liquid to use for 3 weeks | Behavioural | High Concentration / High Power, High Concentration / Low Power |
Primary outcome
Mean Cigarettes Per Day
Time frame: Week 3
Participants complete weekly surveys reporting the number of cigarettes smoked each day on a continuous scale
2 secondary outcomes
Average Number of E-cigarette Puffing Episodes
Time frame: Week 3
Number of Choices to Smoke Cigarette in Lab Setting
Time frame: Week 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 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.
Tracy Smith, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Power, High Power and Low Concentration 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 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 24 Oct 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 24 Oct 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?
Mean Cigarettes Per Day (time frame: Week 3). 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 24 Oct 2024.