The Study of AZD8529 for Smoking Cessation in Female Smokers

Completed · Phase 2

Conditions studied: Tobacco Use Disorder

In brief

To evaluate the efficacy and safety of AZD8529 for smoking cessation in female smokers.

Key facts

Study ID

NCT02401022

Run by

National Institute on Drug Abuse (NIDA)

People needed

214

Starts

2015-07-01

Expected to finish

2017-01-01

Last updated by the study team

2017-11-29

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Be a female smoker between the ages of 18 to 75 years.
• 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.

You may not qualify if…

• Please contact the site for more information

Where it is running

• 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

Full record on ClinicalTrials.gov

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