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Provoked Craving Relief Study by NRT

NCT ID: NCT01476202

Last Updated: 2013-09-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-01-31

Brief Summary

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This study is designed to assess the ability of the mint nicotine mouth strip to relieve provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.

Detailed Description

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Conditions

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Smoking Cessation

Keywords

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craving, provoked craving, smoking cessation, nicotine replacement therapy, NRT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nicotine mouth strip

single dose

Group Type EXPERIMENTAL

nicotine

Intervention Type DRUG

nicotine in the form of a mouth strip, lozenge and gum

nicotine lozenge

single dose

Group Type ACTIVE_COMPARATOR

nicotine

Intervention Type DRUG

nicotine in the form of a mouth strip, lozenge and gum

nicotine gum

single dose

Group Type ACTIVE_COMPARATOR

nicotine

Intervention Type DRUG

nicotine in the form of a mouth strip, lozenge and gum

Interventions

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nicotine

nicotine in the form of a mouth strip, lozenge and gum

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Smoking Status: Current cigarette smokers who have smoked regularly for at least a year and smoke their first cigarette more than 30 minutes after waking up.

Exclusion Criteria

* Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation.
* Any disease that, in the opinion of the investigator, may interfere with the absorption, metabolism or excretion of the study product. A medical history that, in the opinion of the investigator, might jeopardise the safety of the subject or the validity of the study results. For example, recent myocardial infarction or cerebrovascular accident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia.
* Expired Carbon Monoxide (CO): Any subject whose CO level rises during the sequestration period (i.e., the subject's expired CO assessments immediately prior to the provoked craving paradigm are higher than the mean baseline CO assessment) and, in the opinion of the investigator, may have smoked during that time.
* Alcohol: Consumption of any alcoholic beverage within 24 hours of the craving provocation visit, as indicated by a positive breath alcohol test.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Central Kentucky Research Associates, Inc.

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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S2111378

Identifier Type: -

Identifier Source: org_study_id