Clinical trial NCT00150254: 12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.
Official title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Four Dosing Strategies for CP-526,555 ( 0.5 mg BID Titrated, 0.5 mg BID, 1 mg BID, and Titrated 1 mg BID ) in Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 625
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7
Secondary outcomes:
measure: Continuous abstinence rate from target quit date to end of treatment (Week 12)
measure: Carbon monoxide(CO)-confirmed 7-day point prevalence of abstinence at Week 12
measure: Number of cigarettes smoked per day
measure: Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale
measure: Rewarding effects of smoking assessed by Smoking Effects Inventory
measure: Weight change from baselin
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: San Bernardino
country: United States
facility: Pfizer Investigational Site
state: California
city: Upland
country: United States
facility: Pfizer Investigational Site
state: California
city: West Covina
country: United States
facility: Pfizer Investigational Site
state: California
city: Farmington
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: