The Study of AZD8529 for Smoking Cessation in Female Smokers

Phase 2

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Drug: AZD8529

• Registration Number: NCT02401022
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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.

Study Timeline

• Study First Submitted: 2015-03-17
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-27
• Study Start: 2015-07
• Primary Completion: 2016-11
• Study Completion: 2017-01
• Status Verified: 2017-11
• Results First Submitted: 2017-11-01
• Results First Submitted QC: 2017-11-01
• Last Update Submitted: 2017-11-01
• Results First Posted: 2017-11-29
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD8529 low dose	AZD8529	1.5 mg
AZD8529 high dose	AZD8529	40mg

Primary Outcome Measures

Name	Time	Method
Abstinence	Weeks 10 - 13	The number of subjects in each treatment group who are smoking abstinence during the last 4 weeks of the treatment phase (weeks 10 through 13)

Trial Locations

Locations (7)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Pharmacology Research Institute; 🇺🇸 Newport Beach, California, United States

Centers for the Studies of Addiction; 🇺🇸 Philadelphia, Pennsylvania, United States

Pacific Treatment and Research Center; 🇺🇸 La Jolla, California, United States

University of Maryland - College Park; 🇺🇸 College Park, Maryland, United States

Virginia Commonwelath University; 🇺🇸 Richmond, Virginia, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States