Smoking Reduction or Cessation With Nicotine Replacement Therapy

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-02-28

Study Completion Date

2000-05-31

Brief Summary

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

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Detailed Description

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

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nicotine gum

Group Type EXPERIMENTAL

Nicotine gum

Intervention Type DRUG

8-12 pieces per day, maximum 24 daily

Placebo gum

Group Type PLACEBO_COMPARATOR

Placebo gum

Intervention Type DRUG

8-12 pieces per day, maximum 24 daily

Nicotine inhaler

Group Type ACTIVE_COMPARATOR

Nicotine inhaler

Intervention Type DRUG

6-12 cartridges per day, maximum 12 daily

Placebo inhaler

Group Type PLACEBO_COMPARATOR

Placebo inhaler

Intervention Type DRUG

6-12 cartridges per day, maximum 12 daily

Interventions

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Nicotine gum

8-12 pieces per day, maximum 24 daily

Intervention Type DRUG

Placebo gum

8-12 pieces per day, maximum 24 daily

Intervention Type DRUG

Nicotine inhaler

6-12 cartridges per day, maximum 12 daily

Intervention Type DRUG

Placebo inhaler

6-12 cartridges per day, maximum 12 daily

Intervention Type DRUG

Other Intervention Names

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Nicorette® Gum Nicorette® Inhaler

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No