NCT01368016

Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum

Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and Nicotine Gum 4 mg. A Study in Healthy Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 346 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.

Detailed description

This study will be performed at two sites and two-hundred and fifty (250) healthy male and female subjects will be included. Treatments comprise single doses of an experimental Nicotine Replacement Therapy (NRT) and Nicorette Freshfruit gum 4 mg, which are chewed during 30 minutes. All subjects will be given both treatments in a crossover setting. The length of the time interval separating treatment visits, and during which no NRT must be used, will be at least 36 hours. The subjects will abstain from smoking from 8 pm the evening before until the end of each visit. The subjects will take the gums according to instructions from the study personnel. After chewing, used gums will be collected for nicotine analysis. Electronic diaries will be used to collect data. Urges to smoke will be scored on a 100 mm visual analogue scale (VAS) before the start of treatment and during 5 hours thereafter. Subjects will also be monitored to capture any adverse events that may occur.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	Nicotine	A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits
DRUG	Nicotine	A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-06-07
• Last updated: 2012-07-10

Locations

2 sites across 1 country: Sweden