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OpenTrials
Completed

NCT Number: NCT04238832

Salt-Based E-cigarette

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salt Base Nicotine

Other

Participants will try both free base and salt base nicotine e-liquid and then take home salt base nicotine

Free Base Nicotine

Other

Participants will try both free base and salt base nicotine e-liquid and then take home free base nicotine

Primary outcomes

  1. Most preferred product

    Time frame: Lab Visit 2, occurring approximately one week after the initial screening/baseline visit

    Participants complete a preference assessment in which they choose between the salt liquid, free base liquid, or a traditional cigarette in a series of trials. The outcome of this assessment is the product chosen most often by each participant.

Secondary outcomes

  1. Cigarettes per day

    Time frame: Week 2 of study

    The average number of cigarettes smoked per day during the one week sampling period

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Impact of Non-Cigarette Tobacco Product Formulation on Reinforcement Value and Use in Current Smokers

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 23, 2020
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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