Smoking Cessation
Conditions
Brief summary
The purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051018
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have smoked on average of at least ten cigarettes per day during the past year * Subjects must have no period of abstinence greater than three months in the past year
Exclusion criteria
* Subjects with any history of clinically significant cardiovascular disease * Uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Continuous abstinence rate from target quit date to end of treatment (Week 12) | — |
| Carbon monoxide(CO)-confirmed 7-day point prevalence of abstinence at Week 12 | — |
| Number of cigarettes smoked per day | — |
| Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale | — |
| Rewarding effects of smoking assessed by Smoking Effects Inventory | — |
| Weight change from baselin | — |
Countries
United States
Outcome results
None listed