Smoking Reduction or Cessation With Nicotine Replacement Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00840242
Recruitment Status : Completed
First Posted : February 10, 2009
Last Update Posted : April 25, 2012
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )

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

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Nicotine gum Drug: Placebo gum Drug: Nicotine inhaler Drug: Placebo inhaler Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Smoking Reduction or Cessation With Nicotine Replacement Therapy. A Placebo Controlled Double Blind Trial With Nicotine Gum or Inhaler.
Study Start Date : February 1999
Actual Primary Completion Date : May 2000
Actual Study Completion Date : May 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nicotine gum
Nicotine gum
Drug: Nicotine gum
8-12 pieces per day, maximum 24 daily
Other Name: Nicorette® Gum
Placebo Comparator: Placebo gum
Placebo gum
Drug: Placebo gum
8-12 pieces per day, maximum 24 daily
Active Comparator: Nicotine inhaler
Nicotine inhaler
Drug: Nicotine inhaler
6-12 cartridges per day, maximum 12 daily
Other Name: Nicorette® Inhaler
Placebo Comparator: Placebo inhaler
Placebo inhaler
Drug: Placebo inhaler
6-12 cartridges per day, maximum 12 daily

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00840242

Czech Republic
Smoking Cessation Clinic
Kutna Hora, Czech Republic, CZ-28430
Institute of Hygiene and Epidemiology
Prague, Czech Republic, CR-12800
Sponsors and Collaborators
McNeil AB
Study Director: Elisabeth Kruse, PhD McNeil AB

Responsible Party: McNeil AB Identifier: NCT00840242     History of Changes
Other Study ID Numbers: 97 NITG 001
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: April 25, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action