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Varenicline for Alcohol Dependence (NCIG 003)

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: NCT01146613
Recruitment Status : Completed
First Posted : June 17, 2010
Results First Posted : August 11, 2014
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alcoholism
Interventions Drug: Varenicline
Drug: Placebo
Enrollment 200
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline Sugar Pill
Hide Arm/Group Description

Varenicline Tartrate

Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks

Placebo: identical matched placebo x 2, 2xday, 13 weeks
Period Title: Overall Study
Started 99 101
Completed 92 89
Not Completed 7 12
Reason Not Completed
Lost to Follow-up             3             8
Lack of Efficacy             0             1
Death             1             0
Physician Decision             1             0
Withdrawal by Subject             0             3
schedule conflict             1             0
Outpatient detox             1             0
Arm/Group Title Varenicline Sugar Pill Total
Hide Arm/Group Description

Varenicline Tartrate

Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks

Placebo: identical matched placebo x 2, 2xday, 13 weeks Total of all reporting groups
Overall Number of Baseline Participants 97 101 198
Hide Baseline Analysis Population Description
One subject (two records) was excluded from analysis due to his dual study participation at two separate clinical sites. Both instances of participation were in the Varenicline arm and both instances were not considered in the mITT population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 101 participants 198 participants
46  (11) 45  (12.3) 45.5  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 101 participants 198 participants
Female
26
  26.8%
32
  31.7%
58
  29.3%
Male
71
  73.2%
69
  68.3%
140
  70.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 97 participants 101 participants 198 participants
97 101 198
Drinks per day  
Mean (Standard Deviation)
Unit of measure:  Drinks per day
Number Analyzed 97 participants 101 participants 198 participants
14  (9.3) 12.5  (9) 13  (9)
Drinks per drinking day  
Mean (Standard Deviation)
Unit of measure:  Drinks per drinking day
Number Analyzed 97 participants 101 participants 198 participants
15.3  (9.6) 13.6  (9) 14.4  (9.3)
Percent days abstinent  
Mean (Standard Deviation)
Unit of measure:  Percent days abstinent
Number Analyzed 97 participants 101 participants 198 participants
7.7  (12.5) 7.9  (13.6) 7.8  (13)
Percent heavy drinking days  
Mean (Standard Deviation)
Unit of measure:  Percent heavy drinking days
Number Analyzed 97 participants 101 participants 198 participants
88.1  (15.8) 87.2  (16.4) 87.7  (16.1)
Penn Alcohol Craving Scale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 97 participants 101 participants 198 participants
17.7  (6.2) 16.7  (6.8) 17.2  (6.5)
[1]
Measure Description: PACS Scale Range (0-30) - A higher value score equals more craving.
Alcohol-related consequences score - ImBIBE   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 97 participants 101 participants 198 participants
17.8  (9.8) 16.3  (9.7) 17  (9.7)
[1]
Measure Description: ImBIBe - 15 questions (0-60) - Lower score is better The Impact of Beverage Intake on Behavior (ImBIBe) is a 15-item questionnaire in which the subject responds on a 5-point scale to questions on the consequences of alcohol use. This scale was adapted from the Drinker Inventory of Consequences questionnaire based on FDA recommendations on patient reported outcomes (Miller & Tonigen-1995).
Age of onset of regular drinking   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 101 participants 198 participants
18.7  (6.1) 19.3  (5.5) 19  (5.8)
[1]
Measure Description: One question asking at what age regular drinking began.
Gamma-glutamyl transpeptidase (GGT)  
Mean (Standard Deviation)
Unit of measure:  IU/L
Number Analyzed 97 participants 101 participants 198 participants
72.9  (123.5) 70.1  (103.1) 71.9  (113.3)
1.Primary Outcome
Title Weekly Percentage of Heavy Drinking Days
Hide Description Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo.
Time Frame Weeks 2-13*
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Sugar Pill
Hide Arm/Group Description:

Varenicline Tartrate

Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks

Placebo: identical matched placebo x 2, 2xday, 13 weeks
Overall Number of Participants Analyzed 97 101
Mean (Standard Error)
Unit of Measure: percentage of heavy drinking days
37.9  (3.6) 48.4  (3.52)
Time Frame [Not Specified]
Adverse Event Reporting Description AEs were assessed by virtue of an open ended question and by subject report.
 
Arm/Group Title Varenicline Sugar Pill
Hide Arm/Group Description

Varenicline Tartrate

Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks

Placebo: identical matched placebo x 2, 2xday, 13 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 (%) # Events Affected / at Risk (%) # Events
Total   2/97 (2.06%)      2/101 (1.98%)    
General disorders     
Gout  1  0/97 (0.00%)  0 1/101 (0.99%)  1
Injury, poisoning and procedural complications     
Hospitalization for a Heniated Disc  1  0/97 (0.00%)  0 1/101 (0.99%)  1
Hospitalization for Back Surgery  1  1/97 (1.03%)  1 0/101 (0.00%)  0
Death From Gunshot Wound  1  1/97 (1.03%)  1 0/101 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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   88/97 (90.72%)      90/101 (89.11%)    
Gastrointestinal disorders     
constipation  1  9/97 (9.28%)  2/101 (1.98%) 
Diarrhoea  1  11/97 (11.34%)  10/101 (9.90%) 
Nausea  1  36/97 (37.11%)  18/101 (17.82%) 
Vomiting  1  12/97 (12.37%)  10/101 (9.90%) 
General disorders     
Chest Pain  1  0/97 (0.00%)  6/101 (5.94%) 
Fatigue  1  14/97 (14.43%)  11/101 (10.89%) 
Irritability  1  11/97 (11.34%)  5/101 (4.95%) 
Infections and infestations     
Nasopharyngitis  1  6/97 (6.19%)  7/101 (6.93%) 
Upper respiratory tract infection  1  5/97 (5.15%)  4/101 (3.96%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  9/97 (9.28%)  7/101 (6.93%) 
Back Pain  1  6/97 (6.19%)  9/101 (8.91%) 
Nervous system disorders     
Dizziness  1  11/97 (11.34%)  6/101 (5.94%) 
Dysgeusia  1  6/97 (6.19%)  1/101 (0.99%) 
Headache  1  26/97 (26.80%)  30/101 (29.70%) 
Somnolence  1  6/97 (6.19%)  13/101 (12.87%) 
Psychiatric disorders     
Abnormal Dreams  1  27/97 (27.84%)  12/101 (11.88%) 
Agitation  1  12/97 (12.37%)  16/101 (15.84%) 
Anxiety  1  9/97 (9.28%)  8/101 (7.92%) 
Depression  1  7/97 (7.22%)  6/101 (5.94%) 
Hostility  1  6/97 (6.19%)  4/101 (3.96%) 
Insomnia  1  15/97 (15.46%)  12/101 (11.88%) 
Skin and subcutaneous tissue disorders     
Rash  1  3/97 (3.09%)  6/101 (5.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The NIAAA Project Officer is responsible for overseeing the preparation of the main paper summarizing the main findings of the completed Study (the “Main Paper”). No single site data will be published or otherwise disseminated without first consulting and coordinating any such publication or dissemination with the investigators from all stakeholders. Additional manuscripts published after the publication of the Main Paper may be initiated and primarily authored by NIAAA.
Results Point of Contact
Name/Title: Megan Ryan, M.B.A.
Organization: NIAAA
Phone: 301-443-4225
Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT01146613     History of Changes
Other Study ID Numbers: NIAAA-DTRR-2010-LITTEN-003
First Submitted: June 16, 2010
First Posted: June 17, 2010
Results First Submitted: May 14, 2014
Results First Posted: August 11, 2014
Last Update Posted: August 27, 2014