Smoking Reduction or Cessation With Nicotine Replacement Therapy

McNeil-PPC

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

Treatments: Drug: Nicotine gum; Drug: Placebo inhaler; Drug: Nicotine inhaler; Drug: Placebo gum

Study type: Interventional

Funder types: Industry

Identifiers

NCT00840242

97 NITG 001

Details and patient eligibility

About

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

Full description

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

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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314 participants in 4 patient groups, including a placebo group

Nicotine gum

Experimental group

Description:

Nicotine gum

Treatment:

Drug: Nicotine gum

Placebo gum

Placebo Comparator group

Description:

Placebo gum

Treatment:

Drug: Placebo gum

Nicotine inhaler

Active Comparator group

Description:

Nicotine inhaler

Treatment:

Drug: Nicotine inhaler

Placebo inhaler

Placebo Comparator group

Description:

Placebo inhaler

Treatment:

Drug: Placebo inhaler