Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Efficacy of Naltrexone in Women's Smoking Cessation

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Andrea King, University of Chicago
ClinicalTrials.gov Identifier:
NCT00271024
First received: December 28, 2005
Last updated: March 13, 2013
Last verified: March 2013
Results First Received: December 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Smoking
Smoking Cessation
Interventions: Drug: Naltrexone (drug)
Drug: Placebo (for Naltrexone)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment for this study lasted from August 2006-March 2009 with study visits taking place in 3 sites (The University of Chicago, Howard Brown Health Clinic, and the Respiratory Health Association). Follow-up interviews for the study concluded in April 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
  • N=707 screened for participation (320 met exclusion criteria, 54/387 who passed chose not to participate)
  • 333 participants were randomized into the trial

Reporting Groups
  Description
Naltrexone - MALE Males receiving naltrexone as part of the trial
Placebo - MALE Males receiving placebo as part of the trial
Naltrexone - FEMALE Females receiving naltrexone as part of the trial
Placebo - FEMALE Females receiving placebo as part of the trial

Participant Flow:   Overall Study
    Naltrexone - MALE   Placebo - MALE   Naltrexone - FEMALE   Placebo - FEMALE
STARTED   80   77   88   88 
Received Study Treatment   76 [1]   71 [2]   85 [3]   83 [4] 
COMPLETED   58 [5]   51 [6]   65 [7]   64 [8] 
NOT COMPLETED   22   26   23   24 
Lost Interest                3                4                2                3 
Unknown/Unspecified                11                11                8                4 
Protocol Violation                1                6                5                11 
Unpleasant Reaction To Tablet                1                3                4                2 
Time Commitment, Scheduling, or Travel                6                2                4                4 
[1] n=4 did not start treatment (3 lost interest, 1 unknown)
[2] n=6 did not start treatment (1 diff treat. desired, 3 lost interest, 1 began psych meds, 1 unknown)
[3] n=3 did not start treatment (2 lost interest, 1 unknown)
[4] n=5 did not start treatment (2 health problems, 1 wanted diff. treatment method, 2 lost interest)
[5] Discontinued: 1 smoking related, 1 reaction to tablet, 6 time commitment, 2 other, 8 unspecified
[6] Discontinued: 5 smoking related, 3 reaction to tablet, 2 time commitment, 1 other, 9 unspecified
[7] Discontinued: 5 smoking related, 4 reaction to tablet, 4 time commitment, 3 other, 4 unspecified
[8] Discontinued: 9 smoking related, 2 reaction to tablet, 4 time commitment, 1 other, 3 unspecified



  Baseline Characteristics
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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
Naltrexone - MALE Males receiving naltrexone as part of the trial
Placebo - MALE Males receiving placebo as part of the trial
Naltrexone - FEMALE Females receiving naltrexone as part of the trial
Placebo - FEMALE Females receiving placebo as part of the trial
Total Total of all reporting groups

Baseline Measures
   Naltrexone - MALE   Placebo - MALE   Naltrexone - FEMALE   Placebo - FEMALE   Total 
Overall Participants Analyzed 
[Units: Participants]
 80   77   88   88   333 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   80   77   86   88   331 
>=65 years   0   0   2   0   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.45  (10.97)   40.21  (10.98)   44.34  (11.49)   44.95  (10.45)   42.13  (11.27) 
Gender 
[Units: Participants]
         
Female   0   0   88   88   176 
Male   80   77   0   0   157 
Region of Enrollment 
[Units: Participants]
         
United States   80   77   88   88   333 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date   [ Time Frame: 4 Weeks Following Smoking Quit Date (Study week 7) ]

2.  Primary:   Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date   [ Time Frame: 12 Weeks Following Smoking Quit Date (Study week 15) ]

3.  Primary:   7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date   [ Time Frame: 4 Weeks Following Smoking Quit Date (Study week 7) ]

4.  Primary:   7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date   [ Time Frame: 12 Weeks Following Smoking Quit Date (Study week 15) ]

5.  Primary:   7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date   [ Time Frame: 26 Weeks Following Smoking Quit Date (Study week 29) ]

6.  Primary:   7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date   [ Time Frame: 52 Weeks Following Smoking Quit Date (Study week 55) ]

7.  Secondary:   Weight Change at End of Treatment (Smoking Abstinent Only)   [ Time Frame: Weight change at 12 weeks post smoking quit date (study week 15) ]

8.  Secondary:   Weight Change at End of Treatment (Regardless of Quit Status)   [ Time Frame: Weight change at 12 weeks post quit date (study week 15) from smoking quit date ]

9.  Secondary:   Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date   [ Time Frame: 1-Week Post Quit Date (Study Week 4) ]

10.  Secondary:   Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date   [ Time Frame: 4-Weeks Post Quit Date (Study Week 7) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. Andrea King
Organization: University of Chicago
phone: 7737026181
e-mail: aking@bsdad.uchicago.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Andrea King, University of Chicago
ClinicalTrials.gov Identifier: NCT00271024     History of Changes
Other Study ID Numbers: 13976A (R01 DA016834)
R01DA016834 ( US NIH Grant/Contract Award Number )
Study First Received: December 28, 2005
Results First Received: December 19, 2012
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration