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

Tobacco Dependence Clinical Trial

Official title:

Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and Nicotine Gum 4 mg. A Study in Healthy Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368016
• Other study ID #: NICTDP2012
• Secondary ID: 2010-023268-42
• Status: Completed
• Phase: N/A
• First received: June 6, 2011
• Last updated: July 6, 2012
• Start date: April 2011
• Est. completion date: July 2011

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 55 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Tobacco Dependence

Intervention

Drug:
• Nicotine
A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits
• Nicotine
A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits

Locations

Country	Name	City	State
Sweden	Clinical Pharmacology, McNeil AB	Lund
Sweden	Karolinska Trial Alliance (KTA), University Hospital Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
McNeil AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC): Urges to Smoke-vs-Time	Area under urges to smoke-vs.-time curve	During 5 hours post-dose	No
Secondary	Amount of Nicotine Released	The amount of nicotine released during product administration.	30 minutes	No