Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum
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|ClinicalTrials.gov Identifier: NCT01368016|
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : July 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Dependence||Drug: Nicotine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||346 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (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|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
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
- Area Under the Curve (AUC): Urges to Smoke-vs-Time [ Time Frame: During 5 hours post-dose ]Area under urges to smoke-vs.-time curve
- Amount of Nicotine Released [ Time Frame: 30 minutes ]The amount of nicotine released during product administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|