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
Enrollment 214

Recruitment Details  
Pre-assignment Details  
Arm/Group Title AZD8529 Low Dose AZD8529 High Dose
Hide Arm/Group Description Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
Period Title: Overall Study
Started 104 110
Completed 89 90
Not Completed 15 20
Arm/Group Title AZD8529 Low Dose AZD8529 High Dose Total
Hide Arm/Group Description Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks Participants received AZD8529 40 mg capsule orally once daily for 13 weeks Total of all reporting groups
Overall Number of Baseline Participants 104 110 214
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 110 participants 214 participants
48.3  (9.34) 47.3  (9.63) 47.8  (9.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 110 participants 214 participants
Female
104
 100.0%
110
 100.0%
214
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 110 participants 214 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 110 participants 214 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%
1.Primary Outcome
Title Abstinence
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one dose of AZD8529 were included in this population.
Arm/Group Title AZD8529 Low Dose AZD8529 High Dose
Hide Arm/Group Description:
Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
Overall Number of Participants Analyzed 104 110
Measure Type: Count of Participants
Unit of Measure: Participants
10
   9.6%
11
  10.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZD8529 Low Dose AZD8529 High Dose
Hide Arm/Group Description Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
All-Cause Mortality
AZD8529 Low Dose AZD8529 High Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/104 (0.00%)      0/110 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
AZD8529 Low Dose AZD8529 High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/104 (0.00%)      3/110 (2.73%)    
Endocrine disorders     
Small cell lunch cancer  1  0/104 (0.00%)  0 1/110 (0.91%)  1
Pregnancy, puerperium and perinatal conditions     
Pregnancy with sponteneous abortion  1  0/104 (0.00%)  0 1/110 (0.91%)  1
Skin and subcutaneous tissue disorders     
Hidrandenitis  1  0/104 (0.00%)  0 1/110 (0.91%)  1
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
AZD8529 Low Dose AZD8529 High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   74/104 (71.15%)      85/110 (77.27%)    
Blood and lymphatic system disorders     
Lymphadenopathy  1  1/104 (0.96%)  1 1/110 (0.91%)  1
Cardiac disorders     
Antrioventricular block first degree  1  1/104 (0.96%)  1 0/110 (0.00%)  0
Congenital, familial and genetic disorders     
Colour blindness  1  1/104 (0.96%)  1 0/110 (0.00%)  0
Ear and labyrinth disorders     
Ear pain  1  1/104 (0.96%)  1 0/110 (0.00%)  0
Endocrine disorders     
Hypothyroidism  1  1/104 (0.96%)  1 0/110 (0.00%)  0
Eye disorders     
Cataract  1  2/104 (1.92%)  2 1/110 (0.91%)  1
Gastrointestinal disorders     
Diarrhoea  1  6/104 (5.77%)  9 11/110 (10.00%)  12
Nausea  1  9/104 (8.65%)  11 10/110 (9.09%)  10
General disorders     
Fatigue  1  4/104 (3.85%)  4 6/110 (5.45%)  6
Immune system disorders     
Seasonal Allergy  1  2/104 (1.92%)  2 1/110 (0.91%)  1
Infections and infestations     
Upper respiratory tract infection  1  10/104 (9.62%)  10 18/110 (16.36%)  18
Injury, poisoning and procedural complications     
Arthropod Bite  1  1/104 (0.96%)  3 2/110 (1.82%)  2
Investigations     
Weight increased  1  3/104 (2.88%)  3 3/110 (2.73%)  3
Metabolism and nutrition disorders     
Pollakiuria  1  2/104 (1.92%)  2 4/110 (3.64%)  4
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/104 (4.81%)  5 3/110 (2.73%)  3
Nervous system disorders     
Headache  1  14/104 (13.46%)  18 24/110 (21.82%)  36
Psychiatric disorders     
Insomnia  1  6/104 (5.77%)  6 7/110 (6.36%)  7
Reproductive system and breast disorders     
Menorrhagia  1  0/104 (0.00%)  0 2/110 (1.82%)  3
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/104 (4.81%)  5 2/110 (1.82%)  2
Skin and subcutaneous tissue disorders     
Rash  1  3/104 (2.88%)  3 0/110 (0.00%)  0
Surgical and medical procedures     
Dental care  1  0/104 (0.00%)  0 1/110 (0.91%)  1
Vascular disorders     
Hypertension  1  4/104 (3.85%)  4 1/110 (0.91%)  1
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Liza Zeinert
Organization: National Institute on Drug Abuse
Phone: 301-443-1138
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