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Varenicline for Light Smokers (ChanLight)

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ClinicalTrials.gov Identifier: NCT01639560
Recruitment Status : Completed
First Posted : July 12, 2012
Results First Posted : October 13, 2016
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Jon Ebbert, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Smoking
Interventions Drug: Varenicline
Drug: Placebo
Enrollment 93
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description

1 mg of varenicline twice per day for 12 weeks.

Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling

1 placebo tablet twice a day for 12 weeks

Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling

Period Title: Overall Study
Started 45 48
End of Treatment 28 20
Completed 26 19
Not Completed 19 29
Reason Not Completed
Withdrawal by Subject             9             14
Lack of Efficacy             1             2
Lost to Follow-up             9             11
Adverse Event             0             2
Arm/Group Title Varenicline Placebo Total
Hide Arm/Group Description

1 mg of varenicline twice per day for 12 weeks.

Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling

1 placebo tablet twice a day for 12 weeks

Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling

Total of all reporting groups
Overall Number of Baseline Participants 45 48 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 48 participants 93 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
 100.0%
47
  97.9%
92
  98.9%
>=65 years
0
   0.0%
1
   2.1%
1
   1.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 48 participants 93 participants
37.1  (11.7) 37.2  (11.3) 37.2  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 48 participants 93 participants
Female
22
  48.9%
34
  70.8%
56
  60.2%
Male
23
  51.1%
14
  29.2%
37
  39.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 48 participants 93 participants
Hispanic or Latino
0
   0.0%
3
   6.3%
3
   3.2%
Not Hispanic or Latino
45
 100.0%
45
  93.8%
90
  96.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 48 participants 93 participants
American Indian or Alaska Native
1
   2.2%
0
   0.0%
1
   1.1%
Asian
1
   2.2%
0
   0.0%
1
   1.1%
Native Hawaiian or Other Pacific Islander
1
   2.2%
0
   0.0%
1
   1.1%
Black or African American
4
   8.9%
0
   0.0%
4
   4.3%
White
36
  80.0%
48
 100.0%
84
  90.3%
More than one race
2
   4.4%
0
   0.0%
2
   2.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 48 participants 93 participants
45 48 93
Baseline smoking rate (cigarettes per day)  
Mean (Standard Deviation)
Unit of measure:  Cigarettes per day
Number Analyzed 45 participants 48 participants 93 participants
7.9  (1.5) 7.5  (1.5) 7.7  (1.5)
1.Primary Outcome
Title Point Prevalence Smoking Outcome at 12 Weeks (End of Treatment)
Hide Description To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Point prevalence is defined as no smoking in the past 7 days.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:

1 mg of varenicline twice per day for 12 weeks.

Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling

1 placebo tablet twice a day for 12 weeks

Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling

Overall Number of Participants Analyzed 45 48
Measure Type: Number
Unit of Measure: participants
24 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.7
Confidence Interval (2-Sided) 95%
2.5 to 18.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Prolonged Smoking Outcome at 12 Weeks (End of Treatment)
Hide Description To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:

1 mg of varenicline twice per day for 12 weeks.

Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling

1 placebo tablet twice a day for 12 weeks

Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling

Overall Number of Participants Analyzed 45 48
Measure Type: Number
Unit of Measure: participants
18 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.33
Confidence Interval (2-Sided) 95%
2.2 to 24.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Point Prevalence Smoking Outcome at 24 Weeks (End of Study)
Hide Description To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Point prevalence is defined as no smoking in the past 7 days.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:

1 mg of varenicline twice per day for 12 weeks.

Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling

1 placebo tablet twice a day for 12 weeks

Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling

Overall Number of Participants Analyzed 45 48
Measure Type: Number
Unit of Measure: participants
18 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
1.0 to 6.3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Prolonged Smoking Outcome at 24 Weeks (End of Study)
Hide Description To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:

1 mg of varenicline twice per day for 12 weeks.

Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling

1 placebo tablet twice a day for 12 weeks

Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling

Overall Number of Participants Analyzed 45 48
Measure Type: Number
Unit of Measure: participants
14 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.0
Confidence Interval (2-Sided) 95%
1.5 to 16.5
Estimation Comments [Not Specified]
Time Frame Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description

1 mg of varenicline twice per day for 12 weeks.

Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling

1 placebo tablet twice a day for 12 weeks

Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling

All-Cause Mortality
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/45 (0.00%)      0/48 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Varenicline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/45 (40.00%)      4/48 (8.33%)    
Gastrointestinal disorders     
Nausea * 1  10/45 (22.22%)  10 0/48 (0.00%)  0
Gastro-esophageal reflux *  2/45 (4.44%)  2 0/48 (0.00%)  0
Diarrhea *  1/45 (2.22%)  1 0/48 (0.00%)  0
General disorders     
sleep disturbance *  7/45 (15.56%)  7 1/48 (2.08%)  1
Dry Mouth *  1/45 (2.22%)  1 0/48 (0.00%)  0
Loss of appetite * 1  1/45 (2.22%)  1 0/48 (0.00%)  0
Taste Disturbance *  1/45 (2.22%)  1 0/48 (0.00%)  0
Nervous system disorders     
Dizziness *  2/45 (4.44%)  2 0/48 (0.00%)  0
headache *  0/45 (0.00%)  0 1/48 (2.08%)  1
Psychiatric disorders     
Mood Disturbance *  2/45 (4.44%)  2 1/48 (2.08%)  1
Anxiety *  1/45 (2.22%)  1 1/48 (2.08%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Other
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: Jon O. Ebbert, MD
Organization: Mayo Clinic
Phone: 507-266-1944
Responsible Party: Jon Ebbert, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01639560     History of Changes
Other Study ID Numbers: 12-005652
WS2293926 ( Other Grant/Funding Number: Pfizer Inc )
First Submitted: July 10, 2012
First Posted: July 12, 2012
Results First Submitted: August 18, 2016
Results First Posted: October 13, 2016
Last Update Posted: February 22, 2018