Evaluation of pharmokinetics. tobacco withdrawal relief and acceptability of an electronic inhaled nicotine delivery device (Ruyan e-cigarette).

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000587404

Acronym

WIRED

Enrollment

Registered

2007-11-16

Start date

2008-01-15

Completion date

2008-02-20

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

This study tests the hypothesis that a more rapid nicotine delivery from nicotine replacement therapy results in a superior withdrawal relief, and improved product satisfaction. It compares the Ruyan e-cigarette inhaled nicotine delivery device to existing nicotine therapy and placebo, in conferring withdrawal relief in 48 people. Time to peak serum nicotine levels will be compared between the products in 12 of the 48 people. Time to peak concentration will be correlated with reported withdrawal symptoms.

Interventions

Ruyan e-cigarette (16mg nicotine)- inhaled nicotine, taken as required for 8 hours. Nicorette® inhaler - inhaled, but buccal absorption. Regular sessions of puffing for 20 minutes as required over 8 hours. Washout period between treatments is 3 days, when participants will be able to smoke as normal.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Prevention

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

Have smoked 15 cigarettes or more a day for the last year, Smoke within 30 minutes of waking, Self-report being in good health with verification by a brief screening examination, Able to attend the study site for the duration of the study, Able to read and write English, Capable of giving informed consent,

Exclusion criteria

Recent (within 6 months) myocardial infarction, angina pectoris, or other serious medical condition. Severe allergic condition. Poorly controlled asthma or other airways disease. Diabetes mellitus. Current chemical dependence other than nicotine. Poorly controlled psychiatric disorder. Pregnant (will have negative urinary dipstick for ßHCG). Breast feeding. Blood pressure greater than 180 mmHg systolic and/or 100 mmHg diastolic. Current use of other smoking cessation medications of any sort. Participants who are unwilling to abstain from smoking from 8pm the day before each study day until the end of study day (CO verified). Participants who wish to stop smoking during the study period. Participants who smoke only hand rolled cigarettes. Note: participants who wish to cease smoking after the study will be offered assistance (pharmacological treatment and behavioral support).

Outcome results