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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03453385
Other study ID # 493
Secondary ID 1R01CA210625-01A
Status Completed
Phase N/A
First received
Last updated
Start date May 24, 2018
Est. completion date September 8, 2022

Study information

Verified date September 2023
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to measure changes in smoking behavior during and following sampling of an e-cigarette product. E-cigarettes are classified by the US Food and Drug Administration (FDA) as a tobacco product, though they contain no tobacco. Unlike regular cigarettes, which are burned (creating smoke that is inhaled), e-cigarettes include a heating element that vaporizes nicotine. E-cigarettes are likely much safer than conventional cigarettes, but they may not be entirely safe. We are testing the effects of one specific ecigarette (NJoy) on naturalistic changes in smoking behavior. Neither the tobacco industry nor any ecigarette manufacturer provides support of any kind to this study. There is no requirement to quit smoking in this study, nor is there any requirement to use e-cigarettes.


Description:

Eligible smokers, once consented, will be randomized to receive a sample of ecigarettes (NJoy Pre-Filled Tank; n=440) or not (n=220). E-cigarette samples are inclusive of a battery and self-contained tanks of assorted flavors to last up to 4 weeks. Participants will be recruited nationally, but a subset (N=120) will be recruited locally to allow for biomarker collection . Our two-fold purpose is to 1) characterize naturalistic uptake of e-cigarettes, and 2) assess impact of e-cigarette uptake on smoking behavior. All smokers will be asked to provide smoking diary data, captured electronically, daily for 4 weeks. More substantive phone assessment will track smoking and related behaviors at baseline (Day 0) and +10, +17, and +24 days (weekly during initial 3 weeks, following brief lag for delays in product mailing), and at +1, +3, and +6 months.


Recruitment information / eligibility

Status Completed
Enrollment 638
Est. completion date September 8, 2022
Est. primary completion date September 8, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - age 21+, - current smoker - regular use of email OR capacity to receive SMS text and internet access - additional smoking and health criteria determined at screening

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Electronic Cigarette
An e-cigarette and four weeks of e-liquid provided to participants.

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (2)

Lead Sponsor Collaborator
Medical University of South Carolina National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary E-cig Use at End of Sampling Period percentage of participants reporting using an e-cigarette at week 4
Secondary Conversion Percentage of participants who purchase an e-cigarette or additional nicotine liquid on their own Study enrollment through end of 6-month follow up
Secondary Smoking Cessation Point prevalence abstinence from conventional smoking at 6-month follow-up
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