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OpenTrials
Completed

NCT Number: NCT00840242

Smoking Reduction or Cessation With Nicotine Replacement Therapy

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

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Smoking Cessation Clinic, Kutná Hora, Czechia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine gum

Drug

8-12 pieces per day, maximum 24 daily

Other names: Nicorette® Gum

Placebo gum

Drug

8-12 pieces per day, maximum 24 daily

Nicotine Inhaler

Drug

6-12 cartridges per day, maximum 12 daily

Other names: Nicorette® Inhaler

Placebo Inhaler

Drug

6-12 cartridges per day, maximum 12 daily

Primary outcomes

  1. 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

  1. Changes in laboratory values of cardiovascular risk factors

    Time frame: Baseline up to 12 months

  2. Changes in clinical and laboratory exposure parameters

    Time frame: Baseline up to 12 months

Sponsors and collaborators

Lead sponsor

McNeil AB

Industry

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2000
Study completion
2000
First posted
Feb 10, 2009
Registry last updated
Apr 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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