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

• ClinicalTrials.gov Identifier: NCT01075659
• Recruitment Status: Completed
• First Posted: February 25, 2010
• Last Update Posted: July 10, 2012
• Sponsor: McNeil AB
• Information provided by (Responsible Party): Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Drug: Nicotine	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge: A Study in Healthy Smokers
• Study Start Date: February 2010
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: May 2010

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]
4. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• 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

Locations

Sweden

Clinical Pharmacology

Lund, Sweden, 222 20

Sponsors and Collaborators

McNeil AB

Investigators

• Study Director: Elisabeth Kruse, PhD; McNeil AB

More Information

• Responsible Party: McNeil AB
• ClinicalTrials.gov Identifier: NCT01075659
• Other Study ID Numbers: NICTDP2011
• First Posted: February 25, 2010
• Last Update Posted: July 10, 2012
• Last Verified: July 2012

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB ):

Smoking Cessation; VAS; Urges to smoke

Additional relevant MeSH terms:

Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action