The Study of AZD8529 for Smoking Cessation in Female Smokers

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Tobacco Use Disorder

Treatments: Drug: AZD8529

Study type: Interventional

Funder types: NIH

Identifiers

NCT02401022

NIDA/VA CSP - 1032

Details and patient eligibility

About

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

Full description

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.

Enrollment: 214 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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214 participants in 2 patient groups

AZD8529 low dose

Active Comparator group

Description:

1.5 mg

Treatment:

Drug: AZD8529

AZD8529 high dose

Active Comparator group

Description:

40mg

Treatment:

Drug: AZD8529