Clinical trial NCT01075659: Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge
Official title: Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge: A Study in Healthy Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Keywords: Smoking Cessation
VAS
Urges to smoke
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-02-25
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: from time zero following 5 hours of smoking abstinence (baseline), until 5 minutes, until 3 minutes, and until 1 minute, respectively
Secondary outcomes:
measure: Areas under the linearly interpolated urges to smoke vs. time curve (AUC10min)
timeFrame: from time zero following 5 hours of smoking abstinence (baseline), until 10 minutes thereafter
measure: Time to a 25%, 50%, 75%, and 90% reduction from baseline intensity of urges to smoke score
timeFrame: from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter
measure: Proportion of subjects reaching 25%, 50%, 75% and 90% reduction of urges to smoke
timeFrame: from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter
measure: Study treatment acceptability, evaluated using pair-wise treatment comparisons of ordered categorical-scale assessments
timeFrame: At the end of three separate visits, at least 36 hours apart
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Clinical Pharmacology
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References: