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

Phase 2

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Nicotine

• Registration Number: NCT01075659
• Lead Sponsor: McNeil AB

Brief Summary

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

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-24
• Study First Posted: 2010-02-25
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2019706	Nicotine	Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.
LHN1548	Nicotine	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.
2020005	Nicotine	Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.

Primary Outcome Measures

Name	Time	Method
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)	from time zero following 5 hours of smoking abstinence (baseline), until 5 minutes, until 3 minutes, and until 1 minute, respectively

Secondary Outcome Measures

Name	Time	Method
Areas under the linearly interpolated urges to smoke vs. time curve (AUC10min)	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	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	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	At the end of three separate visits, at least 36 hours apart

Trial Locations

Locations (1)

Clinical Pharmacology; 🇸🇪 Lund, Sweden