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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01368016
First received: June 6, 2011
Last updated: July 6, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention
Tobacco Dependence
 Drug: Nicotine

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Amount of Nicotine Released [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    The amount of nicotine released during product administration.


Enrollment: 346
Study Start Date: April 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.
 Drug: Nicotine
A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits
Other Name: Nicorette® Freshfruit gum

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.

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368016

Locations
Sweden
Clinical Pharmacology, McNeil AB
Lund, Sweden, SE-222 20
Karolinska Trial Alliance (KTA), University Hospital Huddinge
Stockholm, Sweden, SE-141 86
Sponsors and Collaborators
McNeil AB
Investigators
Study Director: Elisabeth Kruse, PhD McNeil AB
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT01368016     History of Changes
Other Study ID Numbers: NICTDP2012, 2010-023268-42
Study First Received: June 6, 2011
Last Updated: July 6, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Smoking Cessation
Nicotine Pharmacodynamics

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013