Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum

McNeil-PPC

Status: Completed

Conditions: Tobacco Dependence

Treatments: Drug: Nicotine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01368016

2010-023268-42 (EudraCT Number)

NICTDP2012

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 will be performed at two sites and two-hundred and fifty (250) healthy male and female subjects will be included. Treatments comprise single doses of an experimental Nicotine Replacement Therapy (NRT) and Nicorette Freshfruit gum 4 mg, which are chewed during 30 minutes. All subjects will be given both treatments in a crossover setting. The length of the time interval separating treatment visits, and during which no NRT must be used, will be at least 36 hours.

The subjects will abstain from smoking from 8 pm the evening before until the end of each visit. The subjects will take the gums according to instructions from the study personnel. After chewing, used gums will be collected for nicotine analysis.

Electronic diaries will be used to collect data. Urges to smoke will be scored on a 100 mm visual analogue scale (VAS) before the start of treatment and during 5 hours thereafter. Subjects will also be monitored to capture any adverse events that may occur.

Enrollment: 346 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy subjects, smoking more than 20 cigarettes daily during at least one year preceding inclusion.
• Body Mass Index (BMI) between 17.5 and 32.0 kg/m2 and a total body weight of at least 55.0 kg.
• 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.
• Treatment with an investigational product within one month preceding the first dose of study medication.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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346 participants in 2 patient groups

Experimental NRT

Experimental group

Description:

A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits.

Treatment:

Drug: Nicotine

Drug: Nicotine

Nicotine GUM

Active Comparator group

Description:

A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits.

Treatment:

Drug: Nicotine

Drug: Nicotine