Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge

July 6, 2012 updated by: McNeil AB

Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge: 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 compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 2 mg and 4 mg, respectively, after 5 hours of witnessed nicotine abstinence with respect to urges to smoke during the first 5 minutes after start of treatment. Single doses of each treatment are given during separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 200 healthy smokers between 19-55 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion, and who smoke within 30 minutes of waking up. Subjects, study personnel and monitor will be aware of what type of product is administered at a given visit, but not of the administered dose of the lozenge.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

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, 222 20
        • Clinical Pharmacology

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 smokers, smoking at least 10 cigarettes daily during at least one year preceding inclusion, and smoking within 30 minutes of waking up.
  • 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.
  • Use of NRT, bupropion, or varenicline, or history of a quit attempt later than 3 months before screening visit.
  • Treatment with an investigational product, other than those described in the protocol, between 1 month preceding the first treatment visit and the last treatment visit of the study.
  • Prior regular use of any of the investigational products.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LHN1548
Two single doses of an experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.
Drug: Nicotine
Two single doses of experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period
Other Names:
  • Not yet marketed
Drug: Nicotine
Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.
Other Names:
  • NiQuitin™ lozenge 2 mg
Drug: Nicotine
Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.
Other Names:
  • NiQuitinTM lozenge 4 mg
Active Comparator: 2019706
Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.
Drug: Nicotine
Two single doses of experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period
Other Names:
  • Not yet marketed
Drug: Nicotine
Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.
Other Names:
  • NiQuitin™ lozenge 2 mg
Drug: Nicotine
Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.
Other Names:
  • NiQuitinTM lozenge 4 mg
Active Comparator: 2020005
Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.
Drug: Nicotine
Two single doses of experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period
Other Names:
  • Not yet marketed
Drug: Nicotine
Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.
Other Names:
  • NiQuitin™ lozenge 2 mg
Drug: Nicotine
Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.
Other Names:
  • NiQuitinTM lozenge 4 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Areas under the linearly interpolated urges to smoke vs. time curve evaluated in a hierarchical order starting with the 5 minutes' evaluation (AUC5min, AUC3min, AUC1min)
Time Frame: from time zero following 5 hours of smoking abstinence (baseline), until 5 minutes, until 3 minutes, and until 1 minute, respectively
from time zero following 5 hours of smoking abstinence (baseline), until 5 minutes, until 3 minutes, and until 1 minute, respectively

Secondary Outcome Measures

Outcome Measure
Time Frame
Areas under the linearly interpolated urges to smoke vs. time curve (AUC10min)
Time Frame: from time zero following 5 hours of smoking abstinence (baseline), until 10 minutes thereafter
from time zero following 5 hours of smoking abstinence (baseline), until 10 minutes thereafter
Time to a 25%, 50%, 75%, and 90% reduction from baseline intensity of urges to smoke score
Time Frame: from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter
from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter
Proportion of subjects reaching 25%, 50%, 75% and 90% reduction of urges to smoke
Time Frame: from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter
from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter
Study treatment acceptability, evaluated using pair-wise treatment comparisons of ordered categorical-scale assessments
Time Frame: At the end of three separate visits, at least 36 hours apart
At the end of three separate visits, at least 36 hours apart

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

February 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

February 24, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (Estimate)

February 25, 2010

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

  • NICTDP2011

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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