Clinical trial NCT02357173: A Trial of E-cigarettes in Current Cigarette Smokers
Official title: A Trial of E-cigarettes: Natural Uptake, Patterns and Impact of Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Nicotine Dependence
Nicotine Dependence, Other Tobacco Product
Keywords: smoking
nicotine
tobacco products
electronic cigarette
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-02-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Uptake of Electronic Nicotine Delivery Systems (ENDS)
timeFrame: study week 16
measure: Independent Purchase of an ENDs Product
timeFrame: study enrollment to study week 16
measure: % Quit Attempts
timeFrame: study enrollment to study week 16
measure: Point Prevalence Abstinence
timeFrame: week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Matthew J Carpenter, PhD
role: PRINCIPAL_INVESTIGATOR
References: