Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and Nicotine Gum 4 mg. A Study in Healthy Smokers|
- Area Under the Curve (AUC): Urges to Smoke-vs-Time [ Time Frame: During 5 hours post-dose ] [ Designated as safety issue: No ]Area under urges to smoke-vs.-time curve
- Amount of Nicotine Released [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]The amount of nicotine released during product administration.
|Study Start Date:||April 2011|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Experimental NRT
A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits.
A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits
Other Name: Not yet marketed
Active Comparator: Nicotine GUM
A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits.
A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits
Other Name: Nicorette® Freshfruit gum
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368016
|Clinical Pharmacology, McNeil AB|
|Lund, Sweden, SE-222 20|
|Karolinska Trial Alliance (KTA), University Hospital Huddinge|
|Stockholm, Sweden, SE-141 86|
|Study Director:||Elisabeth Kruse, PhD||McNeil AB|