A pilot study of the pharmacokinetics, efficacy, and acceptability of a novel nicotine inhaler in smokers

A pilot study of the pharmacokinetics, affect on Smoking Urges, and acceptability of a novel nicotine inhaler in smokers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000423516

Enrollment

Registered

2006-10-03

Start date

2006-10-02

Completion date

Unknown

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

A pilot study to test the hypothesis that this novel nicotine inhaler will provide a pharmacokinetic profile very similar to that produced by smoking a cigarette and thus will be effective in reducing smoking urges

Interventions

Cross over study. Interventions: on the first day one smoked cigarette, on the second day 1 inhalation of 50 micrograms of nicotine inhaler every 30s for 5 minutes, on the third day 1 inhalation of 100 micrograms of nicotine inhaler every 30s for 5 min. This allows for a 24-hour wash-out

Study design

Allocation

Non-randomised trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Smoked >10 cigarettes per day.

Exclusion criteria

Recent use of other nicotine replacement therapy such as bupropion; cardiovascular, psychiatric history of note.

Outcome results