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.

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

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Nicotine gum; Drug: Placebo gum; Drug: Nicotine inhaler; Drug: 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

• Study Type: Interventional
• Enrollment (Actual): 314
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czech Republic
  • Kutna Hora, Czech Republic, CZ-28430
    • Smoking Cessation Clinic
  • Prague, Czech Republic, CR-12800
    • Institute of Hygiene and Epidemiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels	Baseline to 6 weeks, 3 and 4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in laboratory values of cardiovascular risk factors	Baseline up to 12 months
Changes in clinical and laboratory exposure parameters	Baseline up to 12 months

Collaborators and Investigators

• Sponsor: McNeil AB

Study record dates

Study Major Dates

• Study Start: February 1, 1999
• Primary Completion (Actual): May 1, 2000
• Study Completion (Actual): May 1, 2000

Study Registration Dates

• First Submitted: February 9, 2009
• First Submitted That Met QC Criteria: February 9, 2009
• First Posted (Estimate): February 10, 2009

Study Record Updates

• Last Update Posted (Estimate): April 25, 2012
• Last Update Submitted That Met QC Criteria: April 24, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 97 NITG 001