Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers

Electronic Cigarettes Clinical Trial

Official title:

Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03830892
• Other study ID #: HM20012696
• Secondary ID: 2U54DA036105
• Status: Terminated
• Phase: N/A
• Start date: January 18, 2019
• Est. completion date: March 6, 2020

Study information

• Verified date: May 2021
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to understand the effects of device power and nicotine concentration on the likelihood that someone would use or abuse e-cigarettes.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• healthy (determined by self-report)
• between the ages of 21-55
• 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 Cigarettes

Intervention

Other:
• E-cigarette Lab Session 15 watts, 10 mg nicotine
E-cigarette paired with low nicotine, low device power
• E-cigarette Lab Session 15 watts, 30 mg nicotine
E-cigarette paired with low nicotine, low device power
• E-cigarette Lab Session 30 watts, 10 mg nicotine
E-cigarette paired with low nicotine, low device power
• E-cigarette Lab Session 30 watts, 30 mg nicotine
E-cigarette paired with low nicotine, low device power
• Own Brand Session - E-cigarette
E-cigarette paired with own brand liquid and preferred power
• Own Brand Session - E-cigarette/Cigarette
Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power

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 Abstinence Symptoms	Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.	First measure given, regardless of task order, 90 minutes into each session
Other	Subjective Measures of Nicotine Abstinence Symptoms	Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.	Third measure given during each session, approximately 120 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).
Other	Subjective Measures of Nicotine Abstinence Symptoms	Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.	Fifth measure given during each session, approximately 180 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).
Other	Subjective Measures of Nicotine Abstinence Symptoms	Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.	Last measure given during each session, approximately 240 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).
Other	Change in Heart Rate	Heart rate (measured in bpm)	Recorded throughout each 4 hour study session using automated software every 10 seconds.
Other	Change in Systolic Blood Pressure	Blood pressure (measured in mm)	Recorded throughout each 4 hour study session using automated software every 5 minutes.
Other	Change in Diastolic Blood Pressure	and blood pressure (measured in hg)	Recorded throughout each 4 hour study session using automated software every 5 minutes.
Primary	Breakpoint of Drug Purchase Tasks (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 (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).	Up to 180 minutes
Primary	Breakpoint of Multiple Choice Procedure (MCP)	The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed). Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).	Up to 180 minutes.
Primary	Effort for Product Puffs With the 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) by measuring the number of puffs self-administrated. Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).	Up to 180 minutes.