Smoking Reduction or Cessation With Nicotine Replacement Therapy

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840242
• Other study ID #: 97 NITG 001
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2009
• Last updated: April 24, 2012
• Start date: February 1999
• Est. completion date: May 2000

Study information

• Verified date: April 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: May 2000
• Est. primary completion date: May 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Nicotine gum
8-12 pieces per day, maximum 24 daily
• Placebo gum
8-12 pieces per day, maximum 24 daily
• Nicotine inhaler
6-12 cartridges per day, maximum 12 daily
• Placebo inhaler
6-12 cartridges per day, maximum 12 daily

Locations

Country	Name	City	State
Czech Republic	Smoking Cessation Clinic	Kutna Hora
Czech Republic	Institute of Hygiene and Epidemiology	Prague

Sponsors (1)

Lead Sponsor	Collaborator
McNeil AB

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels		Baseline to 6 weeks, 3 and 4 months	No
Secondary	Changes in laboratory values of cardiovascular risk factors		Baseline up to 12 months	No
Secondary	Changes in clinical and laboratory exposure parameters		Baseline up to 12 months	No