Effects of E-Cigarette Nicotine Content in Smokers (Nicotine Flux Study)
Study Details
Study Description
Brief Summary
This study aims to better understand how e-cigarettes (ECIG) nicotine flux impacts several behavioral economic measures of abuse liability.
| 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
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
|
Outcome Measures
Primary Outcome Measures
- Breakpoint of Drug Purchase Task (DPT) [Each DPT will be completed once per study session, about 75 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.
- Effort for Product Puffs with Progressive Ratio Task (PRT) [The PRT is completed once per study session, about 90 minutes into the session.]
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.
- Effort for Product Puffs with Cross Product Progressive Ratio Task (CP-PRT) [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.]
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.
Other Outcome Measures
- Subjective measures of nicotine withdrawal [Up to 215 minutes into the session]
Nicotine withdrawal will be measured using the Adapted Minnesota Nicotine Withdrawal Scale (MNWS).
- Subjective measures of nicotine side effects [Up to 215 minutes into the session]
Nicotine side effects will be measured using the Direct Effects of Nicotine Scale (DENS).
- Subjective measures of nicotine side effects [Up to 215 minutes into the session]
Nicotine side effects will be measured using the Direct Effects of Vaping Scale (DEVS).
- General Labeled Magnitude Scale [Up to 215 minutes into the session]
Perceptions of electronic cigarette effects will be measured using the General Labeled Magnitude Scale (gLms).
- Labeled Hedonic Scale [Up to 215 minutes into the session]
Perceptions of electronic cigarette effects will be measured using the General Labeled Magnitude Scale (gLms).
- Subjective perception of nicotine level [Up to 215 minutes into the session]
Participants will be asked if they thought the product they used today contained nicotine.
- Change in Heart Rate [Recorded throughout each 3 hour and 05 minute/ 3 hour and 40 minute study session using automated software every 10 seconds.]
Heart rate (measured in bpm)
- Change in Systolic Blood Pressure [Recorded throughout each 3 hour and 05 minute/ 3 hour and 40 minute study session using automated software every 5 minutes]
Blood pressure (measured in mm)
- Change in Diastolic Blood Pressure [Recorded throughout each 3 hour and 05 minute/ 3 hour and 40 minute study session using automated software every 5 minutes.]]
and blood pressure (measured in hg)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
healthy (determined by self-report)
-
between the ages of 18-55
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willing to provide informed consent
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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:
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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.- HM20018290
- 2U54DA036105