Smoking Reduction or Cessation With Nicotine Replacement Therapy

Phase 3

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Nicotine gum; Drug: Placebo gum; Drug: Nicotine inhaler; Drug: Placebo inhaler

• Registration Number: NCT00840242
• Lead Sponsor: McNeil AB

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

Study Timeline

• Study Start: 1999-02
• Primary Completion: 2000-05
• Study Completion: 2000-05
• Study First Submitted: 2009-02-09
• Study First Submitted QC: 2009-02-09
• Study First Posted: 2009-02-10
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-24
• Last Update Posted: 2012-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine gum	Nicotine gum	Nicotine gum
Placebo gum	Placebo gum	Placebo gum
Nicotine inhaler	Nicotine inhaler	Nicotine inhaler
Placebo inhaler	Placebo inhaler	Placebo inhaler

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Smoking Cessation Clinic; 🇨🇿 Kutna Hora, Czech Republic

Institute of Hygiene and Epidemiology; 🇨🇿 Prague, Czech Republic