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

McNeil-PPC

Status and phase

Completed

Phase 2

Conditions

Smoking Cessation

Treatments

Drug: Nicotine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01075659

NICTDP2011

Details and patient eligibility

About

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

Full 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.

Enrollment

200 patients

Sex

All

Ages

19 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

200 participants in 3 patient groups

LHN1548

Experimental group

Description:

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.

Treatment:

Drug: Nicotine

2019706

Active Comparator group

Description:

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

Treatment:

Drug: Nicotine

2020005

Active Comparator group

Description:

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