- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02294617
E-cigarette vs. Nicotine Inhaler Comparisons
April 9, 2025 updated by: Michael B. Steinberg, MD, MPH, FACP, Rutgers, The State University of New Jersey
Comparative Evaluation of the Perceptions and Utilization of Nicotine Inhalation Devices
The goal of this study is to get information from current smokers about how they feel towards both the electronic cigarette (e-cigarette) and the nicotine oral inhaler.
This will include beliefs, harms, appeal, ease of use, enjoyment, and their use for helping people stop smoking.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Subjects will be seen at Baseline, then 3-days post-baseline, then 9 days post-baseline for post product use questionnaires and carbon monoxide monitoring.
The time frame for follow up is 6 months post Baseline visit.
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Subjects will be smokers 18 years or older, who have had no previous experience with either the e-cigarette or the nicotine oral inhaler, and will be recruited from the local community. They can currently smoke any amount or frequency and with any level of motivation to stop smoking.
Exclusion Criteria:
- Exclusion criteria include recent (within 2 weeks) myocardial infarction or angina, poorly controlled asthma/chronic obstructive pulmonary disease , active substance abuse, pregnancy, or current use of any other cessation medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Nicotrol Inhaler
Subjects will use the Nicotine Inhaler for 3 days.
|
Subjects will use the Nicotrol Inhaler for 3 days.
|
|
Active Comparator: Electronic Cigarette
Subject will use the electronic cigarette for 3 days.
|
Subject will use electronic cigarette for 3 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction of devices on Likert Scale
Time Frame: 6 months (August 2012-December 2013)
|
The goal of this study is to gather data from current smokers regarding their perceptions and experiences with both the e-cigarette and the nicotine oral inhaler over a 6 month time period.
|
6 months (August 2012-December 2013)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
June 23, 2014
First Submitted That Met QC Criteria
November 14, 2014
First Posted (Estimated)
November 19, 2014
Study Record Updates
Last Update Posted (Actual)
April 13, 2025
Last Update Submitted That Met QC Criteria
April 9, 2025
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P30CA072720 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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