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The Study of AZD8529 for Smoking Cessation in Female Smokers

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AZD8529
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring smoking, smoking cessation, cigarette

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Pharmacology Research Institute
  • Pacific Treatment and Research Center
  • Pharmacology Research Institute
  • Pharmacology Research Institute
  • University of Maryland - College Park
  • Columbia University Medical Center
  • University of Cincinnati
  • Centers for the Studies of Addiction
  • Virginia Commonwelath University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AZD8529 low dose

AZD8529 high dose

Arm Description

1.5 mg

40mg

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
March 17, 2015
Last Updated
November 1, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02401022
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
smoking, smoking cessation, cigarette

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZD8529 low dose
Arm Type
Active Comparator
Arm Description
1.5 mg
Arm Title
AZD8529 high dose
Arm Type
Active Comparator
Arm Description
40mg
Intervention Type
Drug
Intervention Name(s)
AZD8529
Other Intervention Name(s)
AZD-8529
Intervention Description
comparison of different dosages of drug
Primary Outcome Measure Information:
Title
Abstinence
Description
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)
Time Frame
Weeks 10 - 13

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shwe Gyaw, MD
Organizational Affiliation
National Institute on Drug Abuse (NIDA)
Official's Role
Study Chair
Facility Information:
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Pacific Treatment and Research Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
University of Maryland - College Park
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Centers for the Studies of Addiction
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Virginia Commonwelath University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Study of AZD8529 for Smoking Cessation in Female Smokers

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