The Study of AZD8529 for Smoking Cessation in Female Smokers
NCT ID: NCT02401022
Last Updated: 2017-11-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
214 participants
INTERVENTIONAL
2015-07-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AZD8529 low dose
1.5 mg
AZD8529
comparison of different dosages of drug
AZD8529 high dose
40mg
AZD8529
comparison of different dosages of drug
Interventions
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AZD8529
comparison of different dosages of drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Want to quit smoking.
* Be currently (last 30 days) smoking 10 or more cigarettes per day and report less than 3 months of consecutive smoking abstinence during the past year.
* Be able, in the opinion of the site investigator (SI), to understand and follow all protocol-specified instructions and understand and provide written informed consent.
* Be willing to provide personal information for entry into a clinical trial registry.
* Agree to use and continue using at least one acceptable contraceptive method (oral contraceptives, IUDs, contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, condoms with spermicide, or abstinence) or, if not of childbearing potential, must fulfill one of the following criteria at screening: post-menopausal defined as amenorrhea for at least 12 months and with follicle stimulating hormone (FSH) levels in the laboratory defined post-menopausal range and/or documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy or tubal ligation verified by the Site Investigator.
* Agree not to use any other smoking behavioral intervention (self-help or formal treatment), acupuncture, or other smoking cessation pharmacotherapy during the study.
* Agree to refrain from using dietary/herbal supplements other than vitamins and minerals for 7 days prior to receiving study drug and throughout the 13-week treatment period.
* Agree to attend all required clinic appointments (including 3 eye exams) during the course of the 19-week study.
Exclusion Criteria
18 Years
75 Years
FEMALE
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Responsible Party
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Principal Investigators
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Shwe Gyaw, MD
Role: STUDY_CHAIR
National Institute on Drug Abuse (NIDA)
Locations
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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
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
Countries
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Other Identifiers
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NIDA/VA CSP - 1032
Identifier Type: -
Identifier Source: org_study_id