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

McNeil AB200 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Smoking Cessation

Interventions

NicotineDRUG

Two single doses of experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period

NicotineDRUG

Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.

NicotineDRUG

Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Pharmacology

Lund, Sweden

Outcomes

Primary Outcomes

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 Outcomes

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

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

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

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

Data from ClinicalTrials.gov

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