Clinical trial NCT04238832: Salt-Based E-cigarette
Official title: Impact of Non-Cigarette Tobacco Product Formulation on Reinforcement Value and Use in Current Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Tobacco Use
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Electronic nicotine delivery systems (ENDS) vary on a wide range of characteristics, which may impact the reinforcement value of the products compared to more harmful combustible products. A new type of low-powered ENDS device has surged in popularity-the pod system. Pods use nicotine salt e-liquids, rather than free-base nicotine solutions that have been used in other ENDS device types. Manufacturers claim that these formulations reduce the harshness of nicotine delivery, while still delivering sufficiently high levels of nicotine. However, the role of nicotine salts in the popularity and use of pod systems remains unclear because no studies have directly manipulated and examined the role of nicotine formulation (salt vs. free base) in reinforcement value and use. The primary purpose of the proposed study is to assess the impact of nicotine formulation (nicotine salt vs. free-base) in reinforcement value and tobacco use. Current smokers (n=30) will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit during which they will sample a traditional cigarette and two ENDS products (nicotine salt ENDS, free base ENDS). All aspects of the device will be held constant other than the nicotine formulation (including nicotine concentration, flavor options, device brand). Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the products they sampled and their own cigarette. Finally, participants will be assigned to take one of the products they sampled home to use ad libitum (1-week sampling). During the at-home baseline and sampling weeks, participants will complete electronic daily diaries cataloging their tobacco use. Biomarkers (i.e., expired carbon monoxide, cotinine) will corroborate self-reported indices of use.


Eligibility criteria: Inclusion Criteria:

* daily cigarette smoker
* interested in using non-cigarette tobacco product
* have a smartphone that can receive text messages and has access to the internet or have an e-mail account they check daily (necessary for daily diary completion).

Exclusion Criteria:

* additional tobacco use criteria
* additional medical criteria

Primary outcomes:
measure: Most preferred product
timeFrame: Lab Visit 2, occurring approximately one week after the initial screening/baseline visit
Secondary outcomes:
measure: Cigarettes per day
timeFrame: Week 2 of study
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: