Smoking Reduction or Cessation With Nicotine Replacement... | NCT00840242

Studies
Smoking Reduction or Cessation With Nicotine Replacement Therapy

NCT00840242

Sponsor

McNeil AB

Status

Completed

Last Update Posted

Apr 25, 2012Estimated

Enrollment

314Actual

Phase

Phase 3

Conditions

Smoking Cessation

Interventions

Nicotine gum
Placebo gum
Nicotine inhaler
Placebo inhaler

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1999

Primary Completion Date

May 2000Actual

Completion Date

May 2000Actual

First Submitted Date

Feb 9, 2009

First Submission Date that Met QC Criteria

Feb 9, 2009

First Posted Date

Feb 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2012

Last Update Posted Date

Apr 25, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to test the success rate of smoking reduction or cessation with different nicotine products.

Detailed Description

To test if smoking reduction or cessation is induced with different nicotine products and to investigate the possible health benefits of smoking reduction

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

314Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nicotine gum	Experimental	Nicotine gum	Drug: Nicotine gum
Placebo gum	Placebo Comparator	Placebo gum	Drug: Placebo gum
Nicotine inhaler	Active Comparator	Nicotine inhaler	Drug: Nicotine inhaler
Placebo inhaler	Placebo Comparator	Placebo inhaler	Drug: Placebo inhaler

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nicotine gum	Drug	8-12 pieces per day, maximum 24 daily	Nicotine gum

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels		Baseline to 6 weeks, 3 and 4 months

Secondary Outcomes

Measure	Description	Time Frame
Changes in laboratory values of cardiovascular risk factors		Baseline up to 12 months
Changes in clinical and laboratory exposure parameters		Baseline up to 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age above 18
Smoking >/= 15 cigarettes/day
Having smoked for 3 years or more
CO >/= 10ppm at inclusion
Want to reduce smoking
Prepared to adhere to the protocol
Willing to provide signed informed consent
Having made at least one serious attempt to quit smoking

Exclusion Criteria:

Unstable angina pectoris, myocardial infarction within the last three months
Use of other nicotine-containing products such as cigars, pipes, snuff
Current use of NRT or involved in behavioral or pharmacological smoking cessation/reduction program
Pregnancy/lactation or intended pregnancy
Under psychiatric care or medication that might interfere with the trial
Abuse of alcohol or any other drug

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elisabeth Kruse, PhD	McNeil AB	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Smoking Cessation Clinic		Kutná Hora		CZ-28430	Czechia
Institute of Hygiene and Epidemiology

Condition Browse Module

MeSH Terms

ID	Term
D016540	Smoking Cessation

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074164	Nicotine Chewing Gum
D009538	Nicotine

Ancestor Terms

ID	Term
D002638	Chewing Gum
D053149	Plant Gums
D001704	Biopolymers
D011108	Polymers
D046911

Browse Leaves

Not provided

Browse Branches

Not provided