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

Smoking Cessation Clinical Trial

Official title:

Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge: A Study in Healthy Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075659
• Other study ID #: NICTDP2011
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2010
• Last updated: July 6, 2012
• Start date: February 2010
• Est. completion date: May 2010

Study information

• Verified date: July 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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
• Nicotine
Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.
• Nicotine
Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.

Locations

Country	Name	City	State
Sweden	Clinical Pharmacology	Lund

Sponsors (1)

Lead Sponsor	Collaborator
McNeil AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No