Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Own Brand Cigarette
|
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.
|
| Experimental: NJOY Ace 2.4% nicotine ECIG - Menthol flavor
|
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.
|
| Experimental: NJOY Ace 2.4% nicotine ECIG - Classic Tobacco flavor
|
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.
|
| Experimental: NJOY Ace 5.0% nicotine ECIG - Menthol flavor
|
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.
|
| Experimental: NJOY Ace 5.0% nicotine ECIG - Classic Tobacco flavor
|
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.
|
| Experimental: NJOY Daily 6.0% nicotine ECIG - Menthol flavor
|
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.
|
| Experimental: NJOY Daily 6.0% nicotine ECIG - Extra Rich Tobacco flavor
|
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.
|
Outcome Measures
Primary Outcome Measures
- Breakpoint of Drug Purchase Task (DPT) [Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session]
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.
- Elasticity of Drug Purchase Task (DPT) [Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session]
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.
- Omax of Drug Purchase Task (DPT) [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.]
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.
- Pmax of Drug Purchase Task (DPT) [Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session]
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.
- Intensity of Drug Purchase Task (DPT) [Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session]
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.
- Cross-price elasticity of the Cross Product-DPT [Each CP-DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session]
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.
Other Outcome Measures
- Subjective measures of nicotine withdrawal [Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session]
Nicotine withdrawal will be measured using the Adapted Minnesota Nicotine Withdrawal Scale (MNWS), higher numbers indicate more nicotine dependence.
- Subjective measures of nicotine side effects [Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session]
Nicotine side effects will be measured using the Direct Effects of Nicotine Scale (DENS), higher scores indicate more intense nicotine side effects.
- Subjective measures of product effects [Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session]
Product effects will be measured using Direct Effects of Tobacco VAS Scale, higher scores indicate more intense product effects.
- General Labeled Magnitude Scale [Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session]
Perceptions of electronic cigarette effects will be measured using the General Labeled Magnitude Scale (gLms), higher scores indicate stronger perceptions of nicotine effects.
- Labeled Hedonic Scale [Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session]
Labeled Hedonic Scale measures nicotine abstinence symptoms, higher scores indicate higher abstinence symptoms
- Change in Heart Rate [Recorded throughout each 1 hour and 10 minutes/2 hour and 15 minute study session using automated software every 10 seconds.]
Heart rate (measured in bpm)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
healthy (determined by self-report)
-
at least 18 years old
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for the Study of Tobacco Products | Richmond | Virginia | United States | 23220 |
Sponsors and Collaborators
- Virginia Commonwealth University
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- HM20025464
- 2U54DA036105