Smoking Cessation
Conditions
Brief summary
The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Cigarette smokers who are motivated to stop smoking and have smoked an average of at least 10 cigarettes per day
Exclusion criteria
* Subjects who have used a nicotine replacement product within 30 days of the study screening visit or intend to use it during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 4-week continuous quit rate (CQR) for Weeks 9-12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Long-term quit rate at Week 52 | — |
| 4-week CQR for Weeks 4-7 | — |
| 7-day point prevalence of asbtinence Weeks 12, Week 24, and Week 52 | — |
| Continuous abstinence from TQD (Week 1) through Week 12 | — |
| Continuous abstinence for Weeks 9-52 and Weeks 9-24 | — |
| Evaluation of withdrawal symptoms by the Minnesota Nicotine Withdrawal Scale | — |
| Evaluation of smoking satisfaction by the Smoking Effects Inventory | — |
| Evaluation of urge to smoke by the Brief Questionnaire of Smoking Urges | — |
| Weekly average number of cigarettes smoked per day for Weeks 1-12 | — |
Countries
Japan
Outcome results
None listed