To evaluate the efficacy and safety of AZD8529 for smoking cessation in female smokers.
This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of two different doses of AZD8529 (1.5 and 40 mg) in smoking cessation. Up to 2 weeks will be allowed for the Screening Period, followed by a 1-week, single-blind run-in period. At the end of Study Week 1 (on Study Day 8), medication compliance will be one of the factors used in a predictive enrichment strategy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
214
comparison of different dosages of drug
Pharmacology Research Institute
Encino, California, United States
Pacific Treatment and Research Center
La Jolla, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Abstinence
The number of subjects in each treatment group who are smoking abstinence during the last 4 weeks of the treatment phase (weeks 10 through 13)
Time frame: Weeks 10 - 13
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Pharmacology Research Institute
Newport Beach, California, United States
University of Maryland - College Park
College Park, Maryland, United States
Columbia University Medical Center
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Centers for the Studies of Addiction
Philadelphia, Pennsylvania, United States
Virginia Commonwelath University
Richmond, Virginia, United States