MedDataX Logo

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

NCT ID: NCT01368016

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Dependence

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Smoking Cessation Nicotine Pharmacodynamics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental NRT

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

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

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

Nicotine GUM

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

Group Type ACTIVE_COMPARATOR

Nicotine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nicotine

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

Intervention Type DRUG

Nicotine

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Not yet marketed Nicorette® Freshfruit gum

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

McNeil AB

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elisabeth Kruse, PhD

Role: STUDY_DIRECTOR

McNeil AB

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Pharmacology, McNeil AB

Lund, , Sweden

Site Status

Karolinska Trial Alliance (KTA), University Hospital Huddinge

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010-023268-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NICTDP2012

Identifier Type: -

Identifier Source: org_study_id