Salt-Based E-cigarette

NCT04238832 | Completed

• 1 other identifier: Pro00093724
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Most preferred product

  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.

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

Secondary Outcomes (1)

• Cigarettes per day

  Week 2 of study

Study Arms (2)

Free Base Nicotine

ACTIVE COMPARATOR

Participants assigned to this group will try both a free base nicotine and a salt base nicotine, and then take home an e-cigarette and free base nicotine e-liquid to sample for one week.

Other: Free Base Nicotine

Salt Base Nicotine

ACTIVE COMPARATOR

Participants assigned to this group will try both a free base nicotine and a salt base nicotine, and then take home an e-cigarette and salt base nicotine e-liquid to sample for one week.

Other: Salt Base Nicotine

Interventions

Salt Base Nicotine OTHER

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

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

Free Base Nicotine

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• additional tobacco use criteria
• additional medical criteria

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the staff nor the participants will be told whether the e-liquid is free base or salt based.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 23, 2020
• Study Start: June 16, 2020
• Primary Completion: July 9, 2021
• Study Completion: July 23, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

US (1)