SmokingNCT02357173
A Trial of E-cigarettes in Current Cigarette Smokers
A study testing electronic cigarette and cigarette group in people with Smoking and Nicotine Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to examine cigarette smokers' use of electronic cigarettes (e-cigarettes), and how use of e-cigarettes affects short term smoking behavior. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Nicotine Dependence, Nicotine Dependence, Other Tobacco Product
- What is being tested?
- electronic cigarette and cigarette group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jul 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18+
- current smoker of at least 5 cigarettes per day for at least 1 year
- at least some concern for health effects of smoking
- having an easily accessible email address
Who cannot join
- past six month use of any e-cigarette
- lifetime ever purchase of any e-cigarette
- recent history of cardiovascular distress (heart attack in past year; arrhythmia; uncontrolled hypertension)
- recent history (past 3 months) of Chronic Obstructive Pulmonary Disease (COPD), cancer (any non-dermatologic), or uncontrolled diabetes mellitus
- pregnant or breastfeeding
- any major current psychiatric impairment, including current alcohol/drug abuse/dependence
Show all 9Show fewer
- use of non-cigarette tobacco products (e.g., cigarillos) in the last 30 days
- current use of any smoking cessation medications
- current enrollment in a smoking cessation treatment 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: A Trial of E-cigarettes: Natural Uptake, Patterns and Impact of Use
The purpose of this study is to examine cigarette smokers' use of electronic cigarettes (e-cigarettes), and how use of e-cigarettes affects short term smoking behavior.
Read the detailed description
Study initiation will commence after the first telephone contact (phone pre-screen), at the baseline visit. Additional lab visits will occur at days 8, 15, and 22 (visits 2-4). At the first study visit, 2/3rds of the participants will be randomly assigned to sample e-cigarettes and 1/3rd will not. Participants in the e-cigarette group will be provided with sufficient product to sample and use as they wish, but with minimal instruction on purpose and level of use (non-use is an outcome). Smokers in the control group will smoke their own brand of cigarettes, as they wish, for the duration of the sampling period. All participants will engage in ecological momentary assessments, which will be completed 3 times daily for 3 weeks. In-person follow-up assessments will be conducted at 1, 2, and 3 months after the final lab visit (Day 22).
Overall, each participant will be contacted 8 times: at the phone pre-screening, the 4 lab visits, and 3 follow-up visits.
- Being tested
- electronic cigarette, cigarette group
- Keywords
- smoking, nicotine, tobacco products, electronic cigarette
- Medical subject headings
- Smoking, Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic cigaretteOther
Also called Blu ecigs
cigarette groupOther
| Study group | Role | What they receive |
|---|---|---|
| cigarette group | Active comparator | This group (1/3 of the sample) will not receive electronic cigarettes to sample and will continue smoking their regular cigarettes as much or as little as they would like. Receives: Other: cigarette group |
| electronic cigarette | Experimental | This group (2/3 of the sample) will be given electronic cigarettes for a 3-week period, to use as much or as little as they would like. Receives: Other: electronic cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of Electronic Nicotine Delivery Systems (ENDS)
% of participants by group used e-cigarettes in week 16
Measured: study week 16
Independent Purchase of an ENDs Product
% of participants by group who purchased an ENDs product on their own during the study
Measured: study enrollment to study week 16
% Quit Attempts
% of participants who made any quit attempt during study
Measured: study enrollment to study week 16
Point Prevalence Abstinence
% of participants with CO-verified cigarette abstinence at study week 16
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionMay 2016
- Study completionJul 2017
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 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
- Sponsor
- Investigators
- Matthew J Carpenter, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357173
- Sponsor's protocol ID
- Pro00035634
- Other IDs
- 1R21DA037407-01
- Status last verified
- Nov 2016
- First submitted
- 3 Oct 2014
- Last updated
- 4 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of E-cigarettes: Natural Uptake, Patterns and Impact of Use
- ClinicalTrials.gov ID
- NCT02357173
- Acronym / sponsor ID
- Pro00035634
- Keywords
- smoking, nicotine, tobacco products, electronic cigarette
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Posted 4 Apr 2018
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 study is to examine cigarette smokers' use of electronic cigarettes (e-cigarettes), and how use of e-cigarettes affects short term smoking behavior.
Detailed description
Study initiation will commence after the first telephone contact (phone pre-screen), at the baseline visit. Additional lab visits will occur at days 8, 15, and 22 (visits 2-4). At the first study visit, 2/3rds of the participants will be randomly assigned to sample e-cigarettes and 1/3rd will not. Participants in the e-cigarette group will be provided with sufficient product to sample and use as they wish, but with minimal instruction on purpose and level of use (non-use is an outcome). Smokers in the control group will smoke their own brand of cigarettes, as they wish, for the duration of the sampling period. All participants will engage in ecological momentary assessments, which will be completed 3 times daily for 3 weeks. In-person follow-up assessments will be conducted at 1, 2, and 3 months after the final lab visit (Day 22).
Overall, each participant will be contacted 8 times: at the phone pre-screening, the 4 lab visits, and 3 follow-up visits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cigarette group | Active comparator | Other: cigarette groupThis group (1/3 of the sample) will not receive electronic cigarettes to sample and will continue smoking their regular cigarettes as much or as little as they would like. |
| electronic cigarette | Experimental | Other: electronic cigaretteThis group (2/3 of the sample) will be given electronic cigarettes for a 3-week period, to use as much or as little as they would like. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18+
- current smoker of at least 5 cigarettes per day for at least 1 year
- at least some concern for health effects of smoking
- having an easily accessible email address
Key exclusion criteria (9 listed)
- past six month use of any e-cigarette
- lifetime ever purchase of any e-cigarette
- recent history of cardiovascular distress (heart attack in past year; arrhythmia; uncontrolled hypertension)
- recent history (past 3 months) of Chronic Obstructive Pulmonary Disease (COPD), cancer (any non-dermatologic), or uncontrolled diabetes mellitus
- pregnant or breastfeeding
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 |
|---|---|---|
| electronic cigaretteAlso: Blu ecigs | Other | electronic cigarette |
| cigarette group | Other | cigarette group |
Primary outcome
Uptake of Electronic Nicotine Delivery Systems (ENDS)
Time frame: study week 16
% of participants by group used e-cigarettes in week 16
Independent Purchase of an ENDs Product
Time frame: study enrollment to study week 16
% of participants by group who purchased an ENDs product on their own during the study
% Quit Attempts
Time frame: study enrollment to study week 16
% of participants who made any quit attempt during study
Point Prevalence Abstinence
Time frame: week 16
% of participants with CO-verified cigarette abstinence at study week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- 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.
Matthew J Carpenter, 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 electronic cigarette and cigarette group in people with Smoking and Nicotine Dependence, 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 4 inclusion and 9 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 4 Apr 2018. 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 4 Apr 2018). 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?
Uptake of Electronic Nicotine Delivery Systems (ENDS) (time frame: study week 16). The study lists 4 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 4 Apr 2018.