Pilot Study of a New Nicotine Replacement Therapy

McNeil-PPC

Status and phase: Completed; Phase 2

Conditions: Smoking Cessation

Treatments: Drug: Nicotine replacement therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00764439

NICTDP2010

2008-002498-11 (EudraCT Number)

Details and patient eligibility

About

Pilot study of a new nicotine replacement therapy for smoking cessation.

Full description

This will be a pilot study of a new nicotine replacement therapy with two different directions for use in smoking cessation.

Enrollment: 258 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older male and female cigarette smokers motivated and willing to stop smoking
• female participants of child-bearing potential should use a medically acceptable means of birth control
• evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate

Exclusion criteria

• unstable angina pectoris or myocardial infarction during the previous 3 months
• pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential)
• participation in other clinical trials within the previous three months and during study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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258 participants in 2 patient groups

1

Active Comparator group

Description:

Standard NRT user direction

Treatment:

Drug: Nicotine replacement therapy

Drug: Nicotine replacement therapy

2

Experimental group

Description:

Novel NRT user direction

Treatment:

Drug: Nicotine replacement therapy

Drug: Nicotine replacement therapy