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

Electronic Cigarette Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04332926
• Other study ID #: HM20018290
• Secondary ID: 2U54DA036105
• Status: Completed
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: September 8, 2023

Study information

• Verified date: June 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 8, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Electronic Cigarette Use

Intervention

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

Locations

Country	Name	City	State
United States	Center for the Study of Tobacco Products	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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.
Other	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
Other	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.]
Primary	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.
Primary	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.
Primary	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.