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Varenicline In-Patient Study (VIP)

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ClinicalTrials.gov Identifier: NCT01413516
Recruitment Status : Completed
First Posted : August 10, 2011
Results First Posted : December 30, 2016
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Judith Prochaska, Stanford University

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
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control: Sugar Pill Without Any Active Medication Experimental: Varenicline
Hide Arm/Group Description

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

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)

Period Title: Overall Study
Started 8 9
Completed 8 9
Not Completed 0 0
Arm/Group Title Control: Sugar Pill Without Any Active Medication Experimental: Varenicline Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 8 9 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 9 participants 17 participants
52  (14) 48  (13) 50  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
Female
4
  50.0%
2
  22.2%
6
  35.3%
Male
4
  50.0%
7
  77.8%
11
  64.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 9 participants 17 participants
8 9 17
1.Primary Outcome
Title 7 Day Point Prevalence Abstinence From All Forms of Tobacco
Hide Description Self report of being quit for 7 continuous days at the time of the 4-week follow-up survey confirmed by saliva cotinine or urine anabasine verification.
Time Frame 4 weeks after beginning study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill Without Any Active Medication Experimental: Varenicline
Hide Arm/Group Description:

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

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)

Overall Number of Participants Analyzed 8 9
Measure Type: Number
Unit of Measure: participants
2 2
Time Frame [Not Specified]
Adverse Event Reporting Description assessed by self-report at every time point
 
Arm/Group Title Control: Sugar Pill Without Any Active Medication Experimental: Varenicline
Hide Arm/Group Description

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

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)

All-Cause Mortality
Control: Sugar Pill Without Any Active Medication Experimental: Varenicline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control: Sugar Pill Without Any Active Medication Experimental: Varenicline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      2/9 (22.22%)    
Musculoskeletal and connective tissue disorders     
Leg amputation  1 [1]  0/8 (0.00%)  0 1/9 (11.11%)  1
Renal and urinary disorders     
Renal disorder  2 [2]  0/8 (0.00%)  0 1/9 (11.11%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, Leg amputation
2
Term from vocabulary, Renal disorder
[1]
This was a planned re-hospitalization for a follow-up surgical procedure. Participant reported finishing his 4-week course of study medication on the day prior to re-hospitalization.
[2]
This adverse event occurred after the participant was scheduled to finish the 4 week course of of study medication. Participant was unable to recall whether taking study medication when the onset of the events described in the narrative occurred.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control: Sugar Pill Without Any Active Medication Experimental: Varenicline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/9 (0.00%)    
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
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: December 8, 2017