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

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

Study Overview

• Status: Completed
• Conditions: Electronic Cigarette Use
• Intervention / Treatment: Other: Tobacco product administration and assessment

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23220
      • Center for the Study of Tobacco Products

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Own Brand Cigarette	Other: Tobacco product administration and assessment; 4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment
Experimental: ECIG 30 Watts, 0 mg/ml nicotine	Other: Tobacco product administration and assessment; 4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment
Experimental: ECIG 30 Watts, 8 mg/ml nicotine	Other: Tobacco product administration and assessment; 4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment
Experimental: ECIG 30 Watts, 15 mg/ml nicotine	Other: Tobacco product administration and assessment; 4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment
Experimental: ECIG 30 Watts, 30 mg/ml nicotine	Other: Tobacco product administration and assessment; 4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breakpoint of Drug Purchase Task (DPT)	The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session.	Each DPT will be completed once per study session, about 75 minutes into the session.
Effort for Product Puffs with Progressive Ratio Task (PRT)	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 three outcome measures. 1) Breakpoint (maximum number of key presses completed to earn a puff), 2) number of puffs self-administrated, and 3) latency (seconds) to initiate key pressing.	The PRT is completed once per study session, about 90 minutes into the session.
Effort for Product Puffs with Cross Product Progressive Ratio Task (CP-PRT)	The CP-PRT will yield a measure of willingness to work for either the session-specific ECIG or the participants own brand tobacco products (via bar presses/work requirement that increases for each of 10 trials for the own brand product while the session-specific product is available for a fixed work requirement). 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.	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective measures of nicotine withdrawal	Nicotine withdrawal will be measured using the Adapted Minnesota Nicotine Withdrawal Scale (MNWS).	Up to 215 minutes into the session
Subjective measures of nicotine side effects	Nicotine side effects will be measured using the Direct Effects of Nicotine Scale (DENS).	Up to 215 minutes into the session
Subjective measures of nicotine side effects	Nicotine side effects will be measured using the Direct Effects of Vaping Scale (DEVS).	Up to 215 minutes into the session
General Labeled Magnitude Scale	Perceptions of electronic cigarette effects will be measured using the General Labeled Magnitude Scale (gLms).	Up to 215 minutes into the session
Labeled Hedonic Scale	Perceptions of electronic cigarette effects will be measured using the General Labeled Magnitude Scale (gLms).	Up to 215 minutes into the session
Subjective perception of nicotine level	Participants will be asked if they thought the product they used today contained nicotine.	Up to 215 minutes into the session
Change in Heart Rate	Heart rate (measured in bpm)	Recorded throughout each 3 hour and 05 minute/ 3 hour and 40 minute study session using automated software every 10 seconds.
Change in Systolic Blood Pressure	Blood pressure (measured in mm)	Recorded throughout each 3 hour and 05 minute/ 3 hour and 40 minute study session using automated software every 5 minutes
Change in Diastolic Blood Pressure	and blood pressure (measured in hg)	Recorded throughout each 3 hour and 05 minute/ 3 hour and 40 minute study session using automated software every 5 minutes.]

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Caroline O Cobb, PhD, Virginia Commonwealth University; Principal Investigator: Andrew Barnes, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): September 8, 2023

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 3, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Electronic Cigarette; Nicotine Flux
• Other Study ID Numbers: HM20018290; 2U54DA036105 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No