Smoking Reduction or Cessation With Nicotine Replacement Therapy. A Placebo Controlled Double Blind Trial With Nicotine Gum or Inhaler.

McNeil AB2 sites in 1 country314 target enrollmentFebruary 1999

ConditionsSmoking Cessation

InterventionsNicotine gum Placebo gum Nicotine inhaler Placebo inhaler

DrugsNicotine gum Placebo gum Nicotine inhaler Placebo inhaler

Overview

Phase: Phase 3
Intervention: Nicotine gum
Conditions: Smoking Cessation
Sponsor: McNeil AB
Enrollment: 314
Locations: 2
Primary Endpoint: Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 1999

End Date

May 2000

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

McNeil AB

Responsible Party

Sponsor

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

Arms & Interventions

Nicotine gum

Intervention: Nicotine gum

Placebo gum

Intervention: Placebo gum

Nicotine inhaler

Intervention: Nicotine inhaler

Placebo inhaler

Intervention: Placebo inhaler

Outcomes

Primary Outcomes

Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels

Time Frame: Baseline to 6 weeks, 3 and 4 months

Secondary Outcomes

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)