Assessment of three e-cigarette nicotine blends, when used by current smokers.

A Four-Way Crossover Study Comparing Nicotine Pharmacokinetics and Exhaled Carbon Monoxide Levels of a Traditional Tobacco Cigarette and Three Nicotine-Based eLiquid Blends Delivered via e-Cigarette, Following Single Use in Healthy Male Smokers.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000522617

Enrollment

Registered

2014-05-16

Start date

2014-05-19

Completion date

2014-06-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Measuring nicotine levels in blood following smoking tobacco and e-cigarettes

Interventions

This study compares three commercially available eliquid blends with a standard cigarette. For each of the 3 blends, nicotine concentration is the same, 2%(w/w), 34uL = 0.8 mg nicotine. Typical e-liquid use is 17-51 uL over 10 inhalations (20 - 60 mg delta weight observed when weighing the e-cig before and after use). This represents between 0.4 - 1.2 mg nicotine per series of 10 inhalations. In particular, researchers want to know: How much nicotine gets into the blood with each product? How quickly does nicotine reach maximum levels in the blood with each product? How much does breath CO increase after using each product? Each participant will smoke one standard tobacco cigarette and 3 e-cigarettes in a randomised order 90 minutes apart

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

Smoke at least 5 cigarettes per day.

Exclusion criteria

Impaired lung function

Outcome results