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

Primary Purpose

Tobacco Dependence

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Nicotine

About this trial

This is an interventional basic science trial for Tobacco Dependence focused on measuring Smoking Cessation, Nicotine Pharmacodynamics

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Clinical Pharmacology, McNeil AB
Karolinska Trial Alliance (KTA), University Hospital Huddinge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental NRT

Nicotine GUM

Arm Description

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

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

Outcomes

Primary Outcome Measures

Area Under the Curve (AUC): Urges to Smoke-vs-Time

Area under urges to smoke-vs.-time curve

Secondary Outcome Measures

Amount of Nicotine Released

The amount of nicotine released during product administration.

Full Information

NCT ID

NCT01368016

First Posted

June 6, 2011

Last Updated

July 6, 2012

Sponsor

McNeil AB

1. Study Identification

Unique Protocol Identification Number

NCT01368016

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McNeil AB

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Dependence

Keywords

Smoking Cessation, Nicotine Pharmacodynamics

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

346 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental NRT

Arm Type

Experimental

Arm Description

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

Arm Title

Nicotine GUM

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nicotine

Other Intervention Name(s)

Not yet marketed

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Nicotine

Other Intervention Name(s)

Nicorette® Freshfruit gum

Intervention Description

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

Primary Outcome Measure Information:

Title

Area Under the Curve (AUC): Urges to Smoke-vs-Time

Description

Area under urges to smoke-vs.-time curve

Time Frame

During 5 hours post-dose

Secondary Outcome Measure Information:

Title

Amount of Nicotine Released

Description

The amount of nicotine released during product administration.

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elisabeth Kruse, PhD

Organizational Affiliation

McNeil AB

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Pharmacology, McNeil AB

City

Lund

ZIP/Postal Code

SE-222 20

Country

Sweden

Facility Name

Karolinska Trial Alliance (KTA), University Hospital Huddinge

City

Stockholm

ZIP/Postal Code

SE-141 86

Country

Sweden

12. IPD Sharing Statement

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

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