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Relapse Prevention With Varenicline (0815)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00944554
First received: July 21, 2009
Last updated: July 28, 2017
Last verified: July 2017
Results First Received: April 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Diagnostic
Conditions: Recurrence
Smoking Cessation
Substance-Related Disorders
Interventions: Drug: Varenicline
Drug: Placebo

  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
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
Placebo Group given placebo twice a day for 5 weeks.
Varenicline Experimental group given varenicline twice a day or five weeks.

Participant Flow:   Overall Study
    Placebo   Varenicline
STARTED   50   54 
COMPLETED   22   25 
NOT COMPLETED   28   29 



  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
Placebo

Group given placebo.

Placebo: Varenicline and placebo given twice a day or five weeks.

Varenicline

Experimental group given varenicline dosing.

Varenicline: Varenicline and placebo given twice a day or five weeks.

Total Total of all reporting groups

Baseline Measures
   Placebo   Varenicline   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   54   104 
Age 
[Units: Years]
Mean (Standard Deviation)
 43  (10)   45  (12)   44  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      20  40.0%      32  59.3%      52  50.0% 
Male      30  60.0%      22  40.7%      52  50.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      0   0.0%      0   0.0%      0   0.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      50 100.0%      54 100.0%      104 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   50   54   104 


  Outcome Measures

1.  Primary:   Days to Relapse   [ Time Frame: 4 weeks ]


  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
Experimental model of relapse used in non-treatment seeking smokers. Results may not generalize to all smokers.


  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: Maxine Stitzer, PhD
Organization: Johns Hopkins University
phone: 410-550-0042
e-mail: mstitze1@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00944554     History of Changes
Other Study ID Numbers: NA_00019900
Study First Received: July 21, 2009
Results First Received: April 20, 2017
Last Updated: July 28, 2017