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

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

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence
• Intervention / Treatment: Drug: Nicotine; Drug: 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 Type: Interventional
• Enrollment (Actual): 346
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, SE-222 20
    • Clinical Pharmacology, McNeil AB
  • Stockholm, Sweden, SE-141 86
    • Karolinska Trial Alliance (KTA), University Hospital Huddinge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental NRT; A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits.	Drug: Nicotine; A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits; Other Names: Not yet marketed; Drug: Nicotine; A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits; Other Names: Nicorette® Freshfruit gum
Active Comparator: Nicotine GUM; A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits.	Drug: Nicotine; A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits; Other Names: Not yet marketed; Drug: Nicotine; A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits; Other Names: Nicorette® Freshfruit gum

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Nicotine Released	The amount of nicotine released during product administration.	30 minutes

Collaborators and Investigators

• Sponsor: McNeil AB

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: June 6, 2011
• First Submitted That Met QC Criteria: June 6, 2011
• First Posted (Estimate): June 7, 2011

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: July 6, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Smoking Cessation; Nicotine Pharmacodynamics
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: NICTDP2012; 2010-023268-42 (EudraCT Number)