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Effects of Varenicline on Smoking Reminders (VSMK)

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ClinicalTrials.gov Identifier: NCT01524627
Recruitment Status : Completed
First Posted : February 2, 2012
Results First Posted : August 17, 2017
Last Update Posted : August 17, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Nicotine Dependence
Interventions Drug: Varenicline
Drug: Placebo
Enrollment 124
Recruitment Details

Subjects were recruited from 1/2012-7/2015. Methods used to recruit were flyers, advertisements on public transportation, Craigslist, word of mouth.

596 potential subjects were phone screened, 124 of those successfully consented, 43 were randomized

Pre-assignment Details  
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description Placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective as Varenicline: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks. Varenicline will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
Period Title: Overall Study
Started 22 21
Completed 21 19
Not Completed 1 2
Reason Not Completed
Physician Decision             0             1
Lost to Follow-up             1             1
Arm/Group Title Placebo Varenicline Total
Hide Arm/Group Description

Participants will receive either varenicline or placebo

Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.

Subjects will receive either varenicline or placebo

Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 22 21 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 43 participants
40.6  (11.1) 36.2  (11.9) 38.1  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
Female
11
  50.0%
12
  57.1%
23
  53.5%
Male
11
  50.0%
9
  42.9%
20
  46.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
White
6
  27.3%
12
  57.1%
18
  41.9%
Black
15
  68.2%
8
  38.1%
23
  53.5%
Asian
1
   4.5%
0
   0.0%
1
   2.3%
Mixed Race
0
   0.0%
1
   4.8%
1
   2.3%
Hispanic
3
  13.6%
1
   4.8%
4
   9.3%
Non-Hispanic
18
  81.8%
21
 100.0%
39
  90.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 21 participants 43 participants
22 21 43
1.Primary Outcome
Title Cigarettes Per Day
Hide Description Cigarettes per day at Baseline versus 8 weeks of treatment, placebo-controlled
Time Frame last week of treatment (1-8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Population was the number of randomized subjects who participated in any treatment length. One subject per group was not included in this analysis as one withdrew a few days after their first scan and the other was lost to follow up after their first scan.
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description:

Participants will receive either varenicline or placebo

Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.

Subjects will receive either varenicline or placebo

Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.

Overall Number of Participants Analyzed 21 20
Mean (Standard Error)
Unit of Measure: cigarettes per day
Baseline 15.7  (2.5) 14.3  (1.8)
Following Treatment 9.8  (2.6) 5.3  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Collected over 5 years during a subject's week 1-8
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description

Participants will receive either varenicline or placebo

Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.

Subjects will receive either varenicline or placebo

Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.

All-Cause Mortality
Placebo Varenicline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Varenicline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/21 (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 (%) # Events Affected / at Risk (%) # Events
Total   13/22 (59.09%)      8/21 (38.10%)    
Gastrointestinal disorders     
Nausea (mild)   3/22 (13.64%)  3 7/21 (33.33%)  10
Nausea (moderate)   2/22 (9.09%)  2 2/21 (9.52%)  2
Nervous system disorders     
Dizziness (mild)   3/22 (13.64%)  3 0/21 (0.00%)  0
Headache (mild)   5/22 (22.73%)  5 0/21 (0.00%)  0
Sedation/Drowsiness (mild)   3/22 (13.64%)  3 2/21 (9.52%)  2
Vivid Dreams (mild)   2/22 (9.09%)  5 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Coughing (mild)   2/22 (9.09%)  2 0/21 (0.00%)  0
Upper Respiratory Infection (moderate)   2/22 (9.09%)  2 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin Irritation (mild)   0/22 (0.00%)  0 2/21 (9.52%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Teresa R. Franklin, Ph.D.
Organization: UPenn
Phone: 215-746-1883
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01524627     History of Changes
Other Study ID Numbers: 813779
1R01DA029845-01A1 ( U.S. NIH Grant/Contract )
First Submitted: January 10, 2012
First Posted: February 2, 2012
Results First Submitted: April 21, 2017
Results First Posted: August 17, 2017
Last Update Posted: August 17, 2017