A Trial of E-cigarettes in Current Cigarette Smokers

Smoking Clinical Trial

Official title:

A Trial of E-cigarettes: Natural Uptake, Patterns and Impact of Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357173
• Other study ID #: Pro00035634
• Secondary ID: 1R21DA037407-01
• Status: Completed
• Phase: N/A
• First received: October 3, 2014
• Last updated: March 7, 2018
• Start date: November 2014
• Est. completion date: July 2017

Study information

• Verified date: November 2016
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Nicotine Dependence
• Nicotine Dependence, Other Tobacco Product
• Smoking
• Tobacco Use Disorder

Intervention

Other:
• electronic cigarette

• cigarette group

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 Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of Electronic Nicotine Delivery Systems (ENDS)	% of participants by group used e-cigarettes in week 16	study week 16
Primary	Independent Purchase of an ENDs Product	% of participants by group who purchased an ENDs product on their own during the study	study enrollment to study week 16
Primary	% Quit Attempts	% of participants who made any quit attempt during study	study enrollment to study week 16
Primary	Point Prevalence Abstinence	% of participants with CO-verified cigarette abstinence at study week 16	week 16