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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01075659
First received: February 24, 2010
Last updated: July 6, 2012
Last verified: July 2012
  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 Phase
Smoking Cessation
Drug: Nicotine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge: A Study in Healthy Smokers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: February 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Not yet marketed
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 Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.
Other Name: NiQuitin™ lozenge 2 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 Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.
Other Name: NiQuitinTM lozenge 4 mg

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.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075659

Locations
Sweden
Clinical Pharmacology
Lund, Sweden, 222 20
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: NCT01075659     History of Changes
Other Study ID Numbers: NICTDP2011
Study First Received: February 24, 2010
Last Updated: July 6, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Smoking Cessation
VAS
Urges to smoke

Additional relevant MeSH terms:
Smoking
Habits
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 April 17, 2014