Trial | NCT00840242  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    nicotine ...

  • Study Participants

    314
The purpose of this study is to test the success rate of smoking reduction or cessation with different nicotine products.
To test if smoking reduction or cessation is induced with different nicotine products and to investigate the possible health benefits of smoking reduction
Study Started
Feb 28
1999
Primary Completion
May 31
2000
Study Completion
May 31
2000
Last Update
Apr 25
2012
Estimate

Drug Nicotine gum

8-12 pieces per day, maximum 24 daily

  • Other names: Nicorette® Gum

Drug Placebo gum

8-12 pieces per day, maximum 24 daily

Drug Nicotine inhaler

6-12 cartridges per day, maximum 12 daily

  • Other names: Nicorette® Inhaler

Drug Placebo inhaler

6-12 cartridges per day, maximum 12 daily

Nicotine gum Experimental

Nicotine gum

Placebo gum Placebo Comparator

Placebo gum

Nicotine inhaler Active Comparator

Nicotine inhaler

Placebo inhaler Placebo Comparator

Placebo inhaler

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
No Results Posted