Clinical trial NCT02401022: The Study of AZD8529 for Smoking Cessation in Female Smokers
Official title: The Study of AZD8529 for Smoking Cessation in Female Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Keywords: smoking
smoking cessation
cigarette
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2015-03-27
Enrollment: 214
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

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

Primary outcomes:
measure: Abstinence
timeFrame: Weeks 10 - 13
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: La Jolla
country: United States
facility: Pacific Treatment and Research Center
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: College Park
country: United States
facility: University of Maryland - College Park
state: Maryland
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: Centers for the Studies of Addiction
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwelath University
state: Virginia
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: Shwe Gyaw, MD
role: STUDY_CHAIR
References: