NCT02401022

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
11 months until next milestone

Results Posted

Study results publicly available

November 29, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

March 17, 2015

Results QC Date

November 1, 2017

Last Update Submit

November 1, 2017

Conditions

Tobacco Use Disorder

Keywords

smokingsmoking cessationcigarette

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

AZD8529 low dose

ACTIVE COMPARATOR

1.5 mg

Drug: AZD8529

AZD8529 high dose

ACTIVE COMPARATOR

40mg

Drug: AZD8529

Interventions

AZD8529DRUG

comparison of different dosages of drug

Also known as: AZD-8529
AZD8529 high doseAZD8529 low dose

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Please contact the site for more information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Pacific Treatment and Research Center

La Jolla, California, 92037, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

University of Maryland - College Park

College Park, Maryland, 20742, United States

Location

Columbia University Medical Center

New York, New York, 10019, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45229, United States

Location

Centers for the Studies of Addiction

Philadelphia, Pennsylvania, 19104, United States

Location

Virginia Commonwelath University

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderSmokingSmoking Cessation

Interventions

AZD8529

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorHealth Behavior

Results Point of Contact

Title
Liza Zeinert
Organization
National Institute on Drug Abuse
liza.zeinert@nih.gov
301-443-1138

Study Officials

  • Shwe Gyaw, MD

    National Institute on Drug Abuse (NIDA)

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2015

First Posted

March 27, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

November 29, 2017

Results First Posted

November 29, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(9)