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Varenicline Treatment for Active Alcoholic Smokers

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ClinicalTrials.gov Identifier: NCT01347112
Recruitment Status : Completed
First Posted : May 4, 2011
Results First Posted : May 30, 2014
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ivana Croghan, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Smoking
Tobacco Dependence
Alcohol Dependence
Interventions Drug: Varenicline
Drug: placebo
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline Sugar Pill
Hide Arm/Group Description

varenicline 1.0 mg twice daily for 12 weeks

Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks

Varenicline look alike sugar pill twice daily for 12 weeks

placebo: sugar pill twice daily for 12 weeks

Period Title: Overall Study
Started 16 17
Completed 12 5
Not Completed 4 12
Reason Not Completed
Withdrawal by Subject             1             7
Lost to Follow-up             3             5
Arm/Group Title Varenicline Sugar Pill Total
Hide Arm/Group Description

varenicline 1.0 mg twice daily for 12 weeks

Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks

Varenicline look alike sugar pill twice daily for 12 weeks

placebo: sugar pill twice daily for 12 weeks

Total of all reporting groups
Overall Number of Baseline Participants 16 17 33
Hide Baseline Analysis Population Description
Intention to treat all randomized subjects included in study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 17 participants 33 participants
40.2  (11.9) 38.8  (10.4) 39.5  (11.0)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
17
 100.0%
33
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Female
6
  37.5%
6
  35.3%
12
  36.4%
Male
10
  62.5%
11
  64.7%
21
  63.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   5.9%
1
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  12.5%
0
   0.0%
2
   6.1%
White
14
  87.5%
16
  94.1%
30
  90.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
16
 100.0%
17
 100.0%
33
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
tobacco use  
Mean (Standard Deviation)
Unit of measure:  Cigarettes per day
Number Analyzed 16 participants 17 participants 33 participants
19.1  (7.5) 21.6  (7.3) 20.4  (7.4)
1.Primary Outcome
Title Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment
Hide Description Prolonged smoking abstinence will be identified by a negative response to the question, "Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?”
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Sugar Pil
Hide Arm/Group Description:

varenicline 1.0 mg twice daily for 12 weeks

Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks

Varenicline look alike sugar pill twice daily for 12 weeks

placebo: sugar pill twice daily for 12 weeks

Overall Number of Participants Analyzed 16 17
Measure Type: Number
Unit of Measure: participants
6 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Sugar Pil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments 1 tailed fisher's exact test
Method Fisher Exact
Comments 1 tailed
2.Secondary Outcome
Title Prolonged Abstinence at 24 Weeks
Hide Description Prolonged abstinence is identified by a negative response to the question, “Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?”
Time Frame week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Sugar Pil
Hide Arm/Group Description:

varenicline 1.0 mg twice daily for 12 weeks

Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks

Varenicline look alike sugar pill twice daily for 12 weeks

placebo: sugar pill twice daily for 12 weeks

Overall Number of Participants Analyzed 16 17
Measure Type: Number
Unit of Measure: participants
4 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Sugar Pil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments 1 tailed fisher's exact
Method Fisher Exact
Comments 1 tailed
3.Secondary Outcome
Title Heavy Drinking Days at End of Treatment
Hide Description Heavy drinking is defined as 5 standard alcohol drinks or greater for men and 4 standard alcohol drinks or greater for women. The number of heavy drinking days per month was determined using the timeline follow-back method.
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Sugar Pill
Hide Arm/Group Description:

varenicline 1.0 mg twice daily for 12 weeks

Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks

Varenicline look alike sugar pill twice daily for 12 weeks

placebo: sugar pill twice daily for 12 weeks

Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: days
7.9  (8.3) 9.1  (7.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.3
Confidence Interval (2-Sided) 90%
-4.7 to 2.1
Estimation Comments data were analyzed using analysis of covariance with treatment as the independent variable and the baseline value included as the co-variate
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline Sugar Pill
Hide Arm/Group Description

varenicline 1.0 mg twice daily for 12 weeks

Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks

Varenicline look alike sugar pill twice daily for 12 weeks

placebo: sugar pill twice daily for 12 weeks

All-Cause Mortality
Varenicline Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/17 (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 Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   5/16 (31.25%)   2/17 (11.76%) 
Gastrointestinal disorders     
nausea *  4/16 (25.00%)  0/17 (0.00%) 
General disorders     
sleep disturbance *  2/16 (12.50%)  0/17 (0.00%) 
vivid dreams *  1/16 (6.25%)  1/17 (5.88%) 
Psychiatric disorders     
depressed mood *  0/16 (0.00%)  1/17 (5.88%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Richard Hurt
Organization: Mayo Clinic
Phone: 507-284-7313
Responsible Party: Ivana Croghan, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01347112     History of Changes
Other Study ID Numbers: 10-008559
10-008309 ( Other Identifier: Mayo Clinic IRB # for Grant )
First Submitted: May 2, 2011
First Posted: May 4, 2011
Results First Submitted: May 1, 2014
Results First Posted: May 30, 2014
Last Update Posted: February 5, 2018