Effects of E-Cigarette Nicotine Content in Smokers (Nicotine Flux Study)

Not Applicable

Completed

• Conditions: Electronic Cigarette Use
• Interventions: Other: Tobacco product administration and assessment

• Registration Number: NCT04332926
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

This study aims to better understand how e-cigarettes (ECIG) nicotine flux impacts several behavioral economic measures of abuse liability.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-31
• Study First Posted: 2020-04-03
• Study Start: 2021-01-05
• Primary Completion: 2023-06-01
• Study Completion: 2023-09-08
• Results First Submitted: 2024-06-21
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Results First Posted: 2025-02-13
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• healthy (determined by self-report)
• between the ages of 18-55
• willing to provide informed consent
• able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol

Exclusion Criteria

• Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
• Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ECIG 30 Watts, 8 mg/ml nicotine	Tobacco product administration and assessment	-
ECIG 30 Watts, 0 mg/ml nicotine	Tobacco product administration and assessment	-
ECIG 30 Watts, 30 mg/ml nicotine	Tobacco product administration and assessment	-
Own Brand Cigarette	Tobacco product administration and assessment	-
ECIG 30 Watts, 15 mg/ml nicotine	Tobacco product administration and assessment	-

Primary Outcome Measures

Name	Time	Method
Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT)	The CP-PRT is completed once per study session (except it is not completed in the 5th, own brand session), at 185 minutes into the session.	This is now a single-arm parallel study design. The main outcome of interest in the CP-PRT is the relative reinforcing value - defined as how hard a participant is willing to work for the session product compared to their own brand cigarette. The breakpoint, or highest trial number that a participant completed for a puff of the session-specific product will be used as the measure of relative reinforcing value.
Breakpoint of Drug Purchase Task (DPT)	Each DPT will be completed once per study session, about 75 minutes into the session. The results will reported in US dollars ($).	The DPTs will yield measures of willingness to pay (demand) for session-specific tobacco products. Choices made during this task are not reinforced during the session. Using the DPT, participants estimate the number of session-specific product puffs they would take across increasing prices per puff. DPT demand will be characterized by the Breakpoint (BP); i.e., the highest price per puff at which participants indicate they would stop using the session-specific product rather than incur the cost.
Effort for Product Puffs With Progressive Ratio Task (PRT)	The PRT is completed once per study session, at 85 minutes into the session.	The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) through the outcome measure: mean number of puffs self-administrated. The outcome measure of interest is the total number of puffs self-administered.

Trial Locations

Locations (1)

Center for the Study of Tobacco Products; 🇺🇸 Richmond, Virginia, United States