A Trial of E-cigarettes in Current Cigarette Smokers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02357173|
Recruitment Status : Completed
First Posted : February 6, 2015
Results First Posted : April 4, 2018
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Smoking Nicotine Dependence Nicotine Dependence, Other Tobacco Product||Other: electronic cigarette Other: cigarette group||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Trial of E-cigarettes: Natural Uptake, Patterns and Impact of Use|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||July 2017|
Active Comparator: cigarette group
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.
Other: cigarette group
Experimental: electronic cigarette
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.
Other: electronic cigarette
Other Name: Blu ecigs
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357173
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Matthew J Carpenter, PhD||Medical University of South Carolina|