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Varenicline In-Patient Study (VIP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01413516
First Posted: August 10, 2011
Last Update Posted: July 2, 2017
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.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Judith Prochaska, Stanford University
Results First Submitted: February 25, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Smoking Cessation
Interventions: Behavioral: Smoking cessation counseling
Drug: Placebo
Drug: Varenicline

  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
Control: Sugar Pill Without Any Active Medication

Smoking counseling, Placebo: Placebo comparator

Interventions:

  • Behavior: smoking counseling
  • Drug: placebo (sugar pill without any active medication)

Smoking counseling: Counseling sessions provided by a trained smoking counselor during 1st day of study along with 28 day supply of placebo

Placebo: Sugar pill without any active medication

Experimental: Varenicline

Smoking counseling, Varenicline: Experimental

Interventions:

  • Behavioral: smoking counseling
  • Drug: varenicline

Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline

Varenicline: Varenicline (an approved medication for smoking cessation)


Participant Flow:   Overall Study
    Control: Sugar Pill Without Any Active Medication   Experimental: Varenicline
STARTED   8   9 
COMPLETED   8   9 
NOT COMPLETED   0   0 



  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
Control: Sugar Pill Without Any Active Medication

Smoking counseling, Placebo: Placebo comparator

Interventions:

  • Behavior: smoking counseling
  • Drug: placebo (sugar pill without any active medication)

Smoking counseling: Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study

Placebo: Sugar pill without any active medication

Experimental: Varenicline

Smoking counseling, Varenicline: Experimental

Interventions:

  • Behavioral: smoking counseling
  • Drug: varenicline

Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline

Varenicline: Varenicline (an approved medication for smoking cessation)

Total Total of all reporting groups

Baseline Measures
   Control: Sugar Pill Without Any Active Medication   Experimental: Varenicline   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   9   17 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      7  87.5%      9 100.0%      16  94.1% 
>=65 years      1  12.5%      0   0.0%      1   5.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 52  (14)   48  (13)   50  (13) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  50.0%      2  22.2%      6  35.3% 
Male      4  50.0%      7  77.8%      11  64.7% 
Region of Enrollment 
[Units: Participants]
     
United States   8   9   17 


  Outcome Measures

1.  Primary:   7 Day Point Prevalence Abstinence From All Forms of Tobacco   [ Time Frame: 4 weeks after beginning study ]

2.  Secondary:   Nicotine Withdrawal and Urges to Smoke   [ Time Frame: 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

3.  Secondary:   Medication Compliance Rate   [ Time Frame: 4 weeks after initial assessment ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

4.  Secondary:   Time to First Cigarette Post-hospitalization   [ Time Frame: 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

5.  Secondary:   Stage of Change   [ Time Frame: 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

6.  Secondary:   Adverse Events   [ Time Frame: 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  


  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: Judith Prochaska
Organization: Stanford University
phone: 6507243608
e-mail: jodi.prochaska@stanford.edu



Responsible Party: Judith Prochaska, Stanford University
ClinicalTrials.gov Identifier: NCT01413516     History of Changes
Other Study ID Numbers: VIP
First Submitted: August 3, 2011
First Posted: August 10, 2011
Results First Submitted: February 25, 2016
Results First Posted: December 30, 2016
Last Update Posted: July 2, 2017