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

Not Applicable

Completed

• Conditions: Tobacco Dependence
• Interventions: Drug: Nicotine

• Registration Number: NCT01368016
• Lead Sponsor: McNeil AB

Brief 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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-06-06
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

• Healthy subjects, smoking more than 20 cigarettes daily during at least one year preceding inclusion.
• Body Mass Index (BMI) between 17.5 and 32.0 kg/m2 and a total body weight of at least 55.0 kg.
• Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
• A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria

• Pregnancy, lactation or intended pregnancy.
• Treatment with an investigational product within one month preceding the first dose of study medication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nicotine GUM	Nicotine	A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits.
Experimental NRT	Nicotine	A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC): Urges to Smoke-vs-Time	During 5 hours post-dose	Area under urges to smoke-vs.-time curve

Secondary Outcome Measures

Name	Time	Method
Amount of Nicotine Released	30 minutes	The amount of nicotine released during product administration.

Trial Locations

Locations (2)

Clinical Pharmacology, McNeil AB; 🇸🇪 Lund, Sweden

Karolinska Trial Alliance (KTA), University Hospital Huddinge; 🇸🇪 Stockholm, Sweden