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

July 6, 2012 updated by: McNeil AB

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: During 5 hours post-dose
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
Time Frame: 30 minutes
The amount of nicotine released during product administration.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McNeil AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NICTDP2012
  • 2010-023268-42 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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