Nicotine AddictionPhase 4NCT01925781
e-Cigarettes Versus NRT Gum for Smoking Cessation
A Phase 4 study testing Nicotine polacrilex and STAM 1100mAh CE4 eGo Clearomizer in people with Nicotine Addiction and Smoking Cessation, run by Creighton University at 1 site in United States.
Trial summary
This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for smoking cessation. Participants will be randomly assigned to either e-cigarette use or nicotine gum use during a quit attempt. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Nicotine Addiction, Smoking Cessation
- What is being tested?
- Nicotine polacrilex and STAM 1100mAh CE4 eGo Clearomizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Nov 2013
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smokes at least five cigarettes per day
- No current or previous regular use of e-cigarettes
- Ready to quit smoking
Who cannot join
- Use of smokeless or pipe tobacco
- Smoke more than 40 cigarettes per day
- Pregnant or breastfeeding
- Unable to chew gum due to dental or jaw problems
- Myocardial infarction (heart attack) within the previous 12 months
- Hypersensitivity to propylene glycol or nicotine gum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: e-Cigarettes Versus Nicotine Replacement Therapy for Smoking Cessation
This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for smoking cessation. Participants will be randomly assigned to either e-cigarette use or nicotine gum use during a quit attempt. All participants will have a one hour meeting with a tobacco treatment specialist to develop a quit plan and set a quit date. Quit status will be determined at 12 weeks after the quit date. Continued use of nicotine replacement (either e-Cigarette or nicotine gum) and satisfaction with the treatment assignment will be evaluated.
- Conditions
- Nicotine Addiction, Smoking Cessation
- Being tested
- Nicotine polacrilex, STAM 1100mAh CE4 eGo Clearomizer
- Keywords
- Smoking Cessation, Nicotine Addiction, e-Cigarette, electronic nicotine delivery device, electronic cigarette, nicotine replacement therapy
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine polacrilexDrug
Also called Nicotine Gum
2 mg and 4 mg gum will be used according to the FDA approved product labelling
STAM 1100mAh CE4 eGo ClearomizerOther
Also called e-Cigarette, electronic nicotine delivery device
| Study group | Role | What they receive |
|---|---|---|
| e-Cigarette | Experimental | STAM 1100mAh CE4 eGo Clearomizer e-Cigarette Receives: Other: STAM 1100mAh CE4 eGo Clearomizer |
| Nicotine polacrilex | Active comparator | Nicotine Replacement gum Receives: Drug: Nicotine polacrilex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Abstinence
No smoking at 12 weeks after the predetermined quit date with a 5 day grace period. Self-report will be biochemically confirmed with expired carbon monoxide (CO) and salivary cotinine.
Measured: 12 weeks
Secondary outcomes (1)
Point Prevalence Abstinence
No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: IND required
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 Nicotine AddictionStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy J Arouni, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925781
- Sponsor's protocol ID
- 13-16684
- Status last verified
- Dec 2015
- First submitted
- 16 Aug 2013
- Last updated
- 14 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-Cigarettes Versus Nicotine Replacement Therapy for Smoking Cessation
- ClinicalTrials.gov ID
- NCT01925781
- Acronym / sponsor ID
- 13-16684
- Conditions
- Nicotine Addiction, Smoking Cessation
- Keywords
- Smoking Cessation, Nicotine Addiction, e-Cigarette, electronic nicotine delivery device, electronic cigarette, nicotine replacement therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IND required
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Posted 14 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for smoking cessation. Participants will be randomly assigned to either e-cigarette use or nicotine gum use during a quit attempt. All participants will have a one hour meeting with a tobacco treatment specialist to develop a quit plan and set a quit date. Quit status will be determined at 12 weeks after the quit date. Continued use of nicotine replacement (either e-Cigarette or nicotine gum) and satisfaction with the treatment assignment will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e-Cigarette | Experimental | Other: STAM 1100mAh CE4 eGo ClearomizerSTAM 1100mAh CE4 eGo Clearomizer e-Cigarette |
| Nicotine polacrilex | Active comparator | Drug: Nicotine polacrilexNicotine Replacement gum |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Smokes at least five cigarettes per day
- No current or previous regular use of e-cigarettes
- Ready to quit smoking
Key exclusion criteria (6 listed)
- Use of smokeless or pipe tobacco
- Smoke more than 40 cigarettes per day
- Pregnant or breastfeeding
- Unable to chew gum due to dental or jaw problems
- Myocardial infarction (heart attack) within the previous 12 months
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 |
|---|---|---|
| Nicotine polacrilexAlso: Nicotine Gum2 mg and 4 mg gum will be used according to the FDA approved product labelling | Drug | Nicotine polacrilex |
| STAM 1100mAh CE4 eGo ClearomizerAlso: e-Cigarette, electronic nicotine delivery device | Other | e-Cigarette |
Primary outcome
Sustained Abstinence
Time frame: 12 weeks
No smoking at 12 weeks after the predetermined quit date with a 5 day grace period. Self-report will be biochemically confirmed with expired carbon monoxide (CO) and salivary cotinine.
1 secondary outcome
Point Prevalence Abstinence
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Nicotine Addiction
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation
Smoking Cessation, Cigarette Smoking
Recruiting
Adapting and Pilot Testing a Skills-based Smoking Cessation Intervention to Address Developmental and Health-related Stress Among Adults Who Smoke
Smoking Cessation, Depression
Not yet recruitingPhase 2
Effects of Psilocybin on Craving in Nicotine Dependence
Nicotine Dependence
Not yet recruitingObservational study
Prevalence and Association of Dysfunctional Breathing With Nicotine Dependence and Physical Activity Among Young Smokers
Dysfunctional Breathing, Physical Activity
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.
Amy J Arouni, MD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine polacrilex and STAM 1100mAh CE4 eGo Clearomizer in people with Nicotine Addiction and Smoking Cessation, run by Creighton University 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: stopped early, as of the sponsor's last update on 14 Jan 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2016). 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?
Sustained Abstinence (time frame: 12 weeks). 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 14 Jan 2016.