Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Varenicline Treatment of Alcohol Dependence in Smokers

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.
ClinicalTrials.gov Identifier: NCT01553136
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : February 12, 2018
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Alcoholism
Alcohol Abuse
Smoking
Alcohol Drinking
Intervention Drug: Varenicline
Enrollment 131
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline Sugar Pill
Hide Arm/Group Description Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
Period Title: Overall Study
Started 64 67
Completed Treatment [1] 55 52
Completed [2] 48 45
Not Completed 16 22
Reason Not Completed
Adverse Event             3             2
Withdrawal by Subject             2             3
Lost to Follow-up             4             10
Physician Decision             2             3
Scheduling Difficulties             5             4
[1]
These data reflect those that had complete alcohol timeline data.
[2]
The completed participants reflect those that continued on medication.
Arm/Group Title Sugar Pill Varenicline Total
Hide Arm/Group Description Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day Total of all reporting groups
Overall Number of Baseline Participants 67 64 131
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 64 participants 131 participants
41.8  (11.7) 43.6  (11.7) 42.7  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 64 participants 131 participants
Female
20
  29.9%
19
  29.7%
39
  29.8%
Male
47
  70.1%
45
  70.3%
92
  70.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 64 participants 131 participants
Hispanic or Latino
10
  14.9%
5
   7.8%
15
  11.5%
Not Hispanic or Latino
57
  85.1%
59
  92.2%
116
  88.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 64 participants 131 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
35
  52.2%
34
  53.1%
69
  52.7%
White
24
  35.8%
26
  40.6%
50
  38.2%
More than one race
8
  11.9%
4
   6.3%
12
   9.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Multiple races ("Other") are reported in the 'More than 1 Race' row.
1.Primary Outcome
Title Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
Hide Description The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
Time Frame weeks 9-12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
Placebo: once per day for Days 1 to 3, twice per day for the remaining days
Overall Number of Participants Analyzed 64 67
Mean (Standard Error)
Unit of Measure: log transformed percentage of days
2.07  (0.23) 2.25  (0.20)
2.Primary Outcome
Title Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
Hide Description The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
Time Frame weeks 13-16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
Placebo: once per day for Days 1 to 3, twice per day for the remaining days
Overall Number of Participants Analyzed 64 67
Mean (Standard Error)
Unit of Measure: log transformed percentage of days
1.99  (0.22) 2.09  (0.21)
3.Primary Outcome
Title Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
Hide Description The percentage of days of heavy drinking will be examined over the final 8 weeks of the study. A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol. Presented here is the average of the 8 weeks (reported as week 17 originally).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
Placebo: once per day for Days 1 to 3, twice per day for the remaining days
Overall Number of Participants Analyzed 64 67
Least Squares Mean (Standard Error)
Unit of Measure: percentage of heavy drinking days
2.40  (0.21) 2.28  (0.21)
4.Secondary Outcome
Title Smoking Abstinence
Hide Description Smoking abstinence is defined by self-reported abstinence from smoking for the last four weeks of treatment (weeks 13-16) and a urine cotinine level less than 15ng/mL measured at week 17.
Time Frame Weeks 13-16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
Placebo: once per day for Days 1 to 3, twice per day for the remaining days
Overall Number of Participants Analyzed 64 67
Measure Type: Count of Participants
Unit of Measure: Participants
8
  12.5%
0
   0.0%
5.Secondary Outcome
Title Drinking Related Consequences
Hide Description A self-report measure of negative consequences from drinking will be administered and the total score are analyzed. The ImBIBe, a measure of alcohol consequences based on the Drinker Inventory of Consequences (DRINC) was used. The DRINC total score has a range from 0-45, 45 being the highest score (or greatest number of negative consequences).
Time Frame End of treatment (Week 17)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
Placebo: once per day for Days 1 to 3, twice per day for the remaining days
Overall Number of Participants Analyzed 64 67
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.29  (0.03) 1.40  (0.03)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline Sugar Pill
Hide Arm/Group Description Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
All-Cause Mortality
Varenicline Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)      0/67 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/64 (3.13%)      0/67 (0.00%)    
Psychiatric disorders     
Suicidal Ideation *  1/64 (1.56%)  1 0/67 (0.00%)  0
Suicidal Behavior * [1]  1/64 (1.56%)  1 0/67 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Patient was admitted to alcohol rehabilitation after trying to 'dink self to death'.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Varenicline Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   47/64 (73.44%)      46/67 (68.66%)    
Ear and labyrinth disorders     
Rhinorrhea   11/64 (17.19%)  9/67 (13.43%) 
Eye disorders     
Blurred Vision   4/64 (6.25%)  2/67 (2.99%) 
Gastrointestinal disorders     
Acid Reflux   5/64 (7.81%)  5/67 (7.46%) 
Constipation   4/64 (6.25%)  9/67 (13.43%) 
Decreased Appetite   11/64 (17.19%)  11/67 (16.42%) 
Diarrhea   4/64 (6.25%)  10/67 (14.93%) 
Dry Mouth   10/64 (15.63%)  5/67 (7.46%) 
Dyspepsia   2/64 (3.13%)  6/67 (8.96%) 
Flatulence   10/64 (15.63%)  8/67 (11.94%) 
Taste Perversion   3/64 (4.69%)  5/67 (7.46%) 
Increased Appetite   11/64 (17.19%)  10/67 (14.93%) 
Increased Bowel Movements   4/64 (6.25%)  2/67 (2.99%) 
Nausea   25/64 (39.06%)  18/67 (26.87%) 
Vomiting   4/64 (6.25%)  7/67 (10.45%) 
General disorders     
Diaphoresis   3/64 (4.69%)  4/67 (5.97%) 
Musculoskeletal and connective tissue disorders     
Joint Pain and Swelling   3/64 (4.69%)  5/67 (7.46%) 
Nervous system disorders     
Disturbance in Attention   6/64 (9.38%)  5/67 (7.46%) 
Fatigue   9/64 (14.06%)  13/67 (19.40%) 
Headache   16/64 (25.00%)  15/67 (22.39%) 
Insomnia   10/64 (15.63%)  9/67 (13.43%) 
Irritability   20/64 (31.25%)  20/67 (29.85%) 
Abnormal Dreams   28/64 (43.75%)  15/67 (22.39%) 
Psychiatric disorders     
Anxiety   8/64 (12.50%)  6/67 (8.96%) 
Depression   11/64 (17.19%)  8/67 (11.94%) 
Renal and urinary disorders     
Frequent Urination   12/64 (18.75%)  7/67 (10.45%) 
Respiratory, thoracic and mediastinal disorders     
Upper Respiratory Infection   4/64 (6.25%)  4/67 (5.97%) 
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: Stephanie Samples O'Malley, PhD, Professor of Psychiatry
Organization: Yale University
Phone: (203) 974-7590
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01553136     History of Changes
Other Study ID Numbers: 1106008598
First Submitted: February 16, 2012
First Posted: March 13, 2012
Results First Submitted: October 17, 2017
Results First Posted: February 12, 2018
Last Update Posted: November 8, 2018