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Relapse Prevention With Varenicline (0815)

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ClinicalTrials.gov Identifier: NCT00944554
Recruitment Status : Completed
First Posted : July 23, 2009
Results First Posted : June 23, 2017
Last Update Posted : August 3, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Diagnostic
Conditions Recurrence
Smoking Cessation
Substance-Related Disorders
Interventions Drug: Varenicline
Drug: Placebo
Enrollment 104
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description Group given placebo twice a day for 5 weeks. Experimental group given varenicline twice a day or five weeks.
Period Title: Overall Study
Started 50 54
Completed 22 25
Not Completed 28 29
Arm/Group Title Placebo Varenicline Total
Hide Arm/Group Description

Group given placebo.

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

Experimental group given varenicline dosing.

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

Total of all reporting groups
Overall Number of Baseline Participants 50 54 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 54 participants 104 participants
43  (10) 45  (12) 44  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 54 participants 104 participants
Female
20
  40.0%
32
  59.3%
52
  50.0%
Male
30
  60.0%
22
  40.7%
52
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 54 participants 104 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 54 participants 104 participants
50 54 104
1.Primary Outcome
Title Days to Relapse
Hide Description Number of days following the programmed lapse exposure until relapse to smoking occurred
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description:
Group given placebo twice a day or five weeks.
Experimental group given varenicline twice a day or five weeks.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: days
9.1  (9.7) 16.4  (10.3)
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description

Group given placebo.

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

Experimental group given varenicline dosing.

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

All-Cause Mortality
Placebo Varenicline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/54 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Varenicline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/54 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Varenicline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/54 (0.00%) 
Experimental model of relapse used in non-treatment seeking smokers. Results may not generalize to all smokers.
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
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00944554     History of Changes
Other Study ID Numbers: NA_00019900
First Submitted: July 21, 2009
First Posted: July 23, 2009
Results First Submitted: April 20, 2017
Results First Posted: June 23, 2017
Last Update Posted: August 3, 2017