The Study of AZD8529 for Smoking Cessation in Female Smokers

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

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Drug: AZD8529

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 Type: Interventional
• Enrollment (Actual): 214
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91316
      • Pharmacology Research Institute
    • La Jolla, California, United States, 92037
      • Pacific Treatment and Research Center
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute
  • Maryland
    • College Park, Maryland, United States, 20742
      • University of Maryland - College Park
  • New York
    • New York, New York, United States, 10019
      • Columbia University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • University of Cincinnati
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Centers for the Studies of Addiction
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwelath University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: AZD8529 low dose; 1.5 mg	Drug: AZD8529; comparison of different dosages of drug; Other Names: AZD-8529
ACTIVE_COMPARATOR: AZD8529 high dose; 40mg	Drug: AZD8529; comparison of different dosages of drug; Other Names: AZD-8529

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)
• Investigators: Study Chair: Shwe Gyaw, MD, National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: March 17, 2015
• First Submitted That Met QC Criteria: March 23, 2015
• First Posted (ESTIMATE): March 27, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 1, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: smoking; smoking cessation; cigarette
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: NIDA/VA CSP - 1032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO