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Smoking Reduction or Cessation With Nicotine Replacement Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT00840242
First received: February 9, 2009
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Smoking Cessation
 Drug: Nicotine gum
Drug: Placebo gum
Drug: Nicotine inhaler
Drug: Placebo inhaler
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels [ Time Frame: Baseline to 6 weeks, 3 and 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in laboratory values of cardiovascular risk factors [ Time Frame: Baseline up to 12 months ] [ Designated as safety issue: No ]
  • Changes in clinical and laboratory exposure parameters [ Time Frame: Baseline up to 12 months ] [ Designated as safety issue: No ]

Enrollment: 314
Study Start Date: February 1999
Study Completion Date: May 2000
Primary Completion Date: May 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo Gum
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
Other Name: Placebo inhaler

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840242

Locations
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
Investigators
Study Director: Elisabeth Kruse, PhD McNeil AB
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT00840242     History of Changes
Other Study ID Numbers: 97 NITG 001
Study First Received: February 9, 2009
Last Updated: April 24, 2012
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013