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Phase 2 Completed N=214 Randomized Triple-blind Treatment

The Study of AZD8529 for Smoking Cessation in Female Smokers

Source: ClinicalTrials.gov NCT02401022 ↗
Enrolled (actual)
214
Serious AEs
1.4%
Results posted
Nov 2017
Primary outcomePrimary: Abstinence — 10; 11 Participants

Summary

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Abstinence
10; 11

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Please contact the site for more information
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02401022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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