The Study of AZD8529 for Smoking Cessation in Female Smokers

Tobacco Use Disorder Clinical Trial

Official title:

The Study of AZD8529 for Smoking Cessation in Female Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401022
• Other study ID #: NIDA/VA CSP - 1032
• Status: Completed
• Phase: Phase 2
• First received: March 17, 2015
• Last updated: November 1, 2017
• Start date: July 2015
• Est. completion date: January 2017

Study information

• Verified date: November 2017
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• AZD8529
comparison of different dosages of drug

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Maryland - College Park	College Park	Maryland
United States	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	Columbia University Medical Center	New York	New York
United States	Pharmacology Research Institute	Newport Beach	California
United States	Centers for the Studies of Addiction	Philadelphia	Pennsylvania
United States	Virginia Commonwelath University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence	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)	Weeks 10 - 13