Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)

Electronic Cigarette Use Clinical Trial

Official title:

Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05971823
• Other study ID #: HM20025464
• Secondary ID: 2U54DA036105
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: August 2023
• Source: Virginia Commonwealth University
• Contact: Caroline O Cobb, PhD
• Phone: 804-827-3562
• Email: cobbco[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if abuse liability indices will be impacted by varying flavors and e-cigarette (ECIG) nicotine delivery capability (i.e., nicotine flux) among current combustible cigarette users.

The investigators will compare abuse liability indices between three FDA-authorized ECIG products that vary in nicotine flux (but are all tobacco flavor) and own brand cigarettes. The investigators will also test the influence of ECIG flavor availability (tobacco vs. menthol) within three ECIG product classes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• healthy (determined by self-report)

• at least 18 years old

• willing to provide informed consent

• able to attend the lab and use designated products according to study protocol

• smoke cigarettes at least 3 days per week and on those days at least 1 cigarette smoked per day

• positive urine cotinine test

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
Subjective measures 1 is followed by product sampling that includes 5 self-directed ECIG/own brand cigarette puffs over 10 minutes. After sampling is complete participants complete subjective measures 2. Ten minutes after their sampling has been completed, they complete subjective measures 3 and the behavioral economic task(s). These activities are preceded and followed by cardiovascular response 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), higher numbers indicate more nicotine dependence.	Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
Other	Subjective measures of nicotine side effects	Nicotine side effects will be measured using the Direct Effects of Nicotine Scale (DENS), higher scores indicate more intense nicotine side effects.	Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
Other	Subjective measures of product effects	Product effects will be measured using Direct Effects of Tobacco VAS Scale, higher scores indicate more intense product effects.	Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
Other	General Labeled Magnitude Scale	Perceptions of electronic cigarette effects will be measured using the General Labeled Magnitude Scale (gLms), higher scores indicate stronger perceptions of nicotine effects.	Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
Other	Labeled Hedonic Scale	Labeled Hedonic Scale measures nicotine abstinence symptoms, higher scores indicate higher abstinence symptoms	Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
Other	Change in Heart Rate	Heart rate (measured in bpm)	Recorded throughout each 1 hour and 10 minutes/2 hour and 15 minute study session using automated software every 10 seconds.
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 twice per study session, about 55 minutes into the session and again at 120 minutes into the session
Primary	Elasticity 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 twice per study session, about 55 minutes into the session and again at 120 minutes into the session
Primary	Omax 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.	A DPT will be Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session once for each arm.
Primary	Pmax 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 twice per study session, about 55 minutes into the session and again at 120 minutes into the session
Primary	Intensity 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 twice per study session, about 55 minutes into the session and again at 120 minutes into the session
Primary	Cross-price elasticity of the Cross Product-DPT	The Cross Product (CP)-DPTs assess cross-product purchasing behaviors between various tobacco products offered at a fixed amount and own brand cigarettes offered at varying prices.	Each CP-DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session