ClinicalTrials.gov
ClinicalTrials.gov Menu

The Study of AZD8529 for Smoking Cessation in Female Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Tobacco Use Disorder
Intervention: Drug: AZD8529

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AZD8529 Low Dose Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
AZD8529 High Dose Participants received AZD8529 40 mg capsule orally once daily for 13 weeks

Participant Flow:   Overall Study
    AZD8529 Low Dose   AZD8529 High Dose
STARTED   104   110 
COMPLETED   89   90 
NOT COMPLETED   15   20 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AZD8529 Low Dose Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
AZD8529 High Dose Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
Total Total of all reporting groups

Baseline Measures
   AZD8529 Low Dose   AZD8529 High Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 104   110   214 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.3  (9.34)   47.3  (9.63)   47.8  (9.47) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      104 100.0%      110 100.0%      214 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      12  11.5%      12  10.9%      24  11.2% 
Not Hispanic or Latino      91  87.5%      97  88.2%      188  87.9% 
Unknown or Not Reported      1   1.0%      1   0.9%      2   0.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   1.0%      0   0.0%      1   0.5% 
Asian      2   1.9%      1   0.9%      3   1.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      23  22.1%      29  26.4%      52  24.3% 
White      75  72.1%      76  69.1%      151  70.6% 
More than one race      3   2.9%      3   2.7%      6   2.8% 
Unknown or Not Reported      0   0.0%      1   0.9%      1   0.5% 


  Outcome Measures

1.  Primary:   Abstinence   [ Time Frame: Weeks 10 - 13 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Liza Zeinert
Organization: National Institute on Drug Abuse
phone: 301-443-1138
e-mail: liza.zeinert@nih.gov



Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT02401022     History of Changes
Other Study ID Numbers: NIDA/VA CSP - 1032
First Submitted: March 17, 2015
First Posted: March 27, 2015
Results First Submitted: November 1, 2017
Results First Posted: November 29, 2017
Last Update Posted: November 29, 2017