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The Study of AZD8529 for Smoking Cessation in Female Smokers

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ClinicalTrials.gov Identifier: NCT02401022
Recruitment Status : Completed
First Posted : March 27, 2015
Results First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)

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

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: AZD8529 Phase 2

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  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Study of AZD8529 for Smoking Cessation in Female Smokers
Study Start Date : July 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: AZD8529 low dose
1.5 mg
Drug: AZD8529
comparison of different dosages of drug
Other Name: AZD-8529

Active Comparator: AZD8529 high dose
40mg
Drug: AZD8529
comparison of different dosages of drug
Other Name: AZD-8529




Primary Outcome Measures :
  1. Abstinence [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401022


Locations
United States, California
Pharmacology Research Institute
Encino, California, United States, 91316
Pacific Treatment and Research Center
La Jolla, California, United States, 92037
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
Pharmacology Research Institute
Newport Beach, California, United States, 92660
United States, Maryland
University of Maryland - College Park
College Park, Maryland, United States, 20742
United States, New York
Columbia University Medical Center
New York, New York, United States, 10019
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Centers for the Studies of Addiction
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Virginia Commonwelath University
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Study Chair: Shwe Gyaw, MD National Institute on Drug Abuse (NIDA)

Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT02401022     History of Changes
Other Study ID Numbers: NIDA/VA CSP - 1032
First Posted: March 27, 2015    Key Record Dates
Results First Posted: November 29, 2017
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by National Institute on Drug Abuse (NIDA):
smoking
smoking cessation
cigarette

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders