Cigarette smoking Not Applicable Smoking
Conditions
Interventions
Treatment was administered for the first six weeks of the 8-week study. Patients were instructed to continue smoking for the first two weeks of treatment.
Patients were randomised into one of the foll
Sponsors
Elan Corp (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females motivated to quit smoking between the ages of 18 and 70 years 2. Smoked at least 20 cigarettes a day for three years or more (smoking confirmed via expired CO level >10 ppm). All subjects had normal blood pressure and heart rate, weighed more than 100 pounds and typically no more than 130% of their ideal body weight, and expressed willingness to quit smoking on the specified target quit date (TQD). They were not currently using smokeless tobacco or other nicotine products. A detailed medical history, routine physical examination, laboratory tests and electrocardiogram (ECG) confirmed that subjects were in general good health. All women had a negative pregnancy test and agreed to use a medically accurate contraceptive method.
Exclusion criteria
Exclusion criteria: Participants were excluded if they had a history of significant hepatic, renal, endocrine, cardiac, psychiatric, gastrointestinal, pulmonary, or metabolic disorder including hyperthyroidism, pheochromocytoma, diabetes, severe coronary insufficiency, recent myocardial infarction (within 90 days), glaucoma, cerebrovascular disease, stroke, chronic renal failure, prostatic hypertrophy, prostatic disease, bladder neck obstruction, urine retention, urethral stricture, a history of atopic or eczematous dermatitis, psoriasis, or altered skin condition at patch application site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of the four-week continuous abstinence for the intent-to-treat population using the slip definition, which allows smoking in the first two weeks after the quit date. | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of the four-week continuous abstinence for the intent-to-treat population using the strict definition (no smoking after the quit date). | — |
Countries
United States of America
Outcome results
None listed