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Varenicline to Reduce Alcohol Consumption in Heavy Drinkers

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ClinicalTrials.gov Identifier: NCT00695500
Recruitment Status : Completed
First Posted : June 12, 2008
Results First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Vijay Ramchandani, Ph.D., National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Alcohol Drinking
Interventions Drug: Varenicline
Drug: Placebo
Enrollment 50
Recruitment Details  
Pre-assignment Details Four participants were enrolled (consented) but withdrew prior to group assignment.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description Varenicline tablets, 2 mg per day for 3 weeks Placebo tablets, 0 mg per day for 3 weeks
Period Title: Overall Study
Started 24 22
Completed 21 17
Not Completed 3 5
Arm/Group Title Varenicline Placebo Total
Hide Arm/Group Description Varenicline tablets, 2 mg per day for 3 weeks Placebo tablets, 0 mg per day for 3 weeks Total of all reporting groups
Overall Number of Baseline Participants 24 22 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 participants
<=18 years
2
   8.3%
1
   4.5%
3
   6.5%
Between 18 and 65 years
22
  91.7%
21
  95.5%
43
  93.5%
>=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 24 participants 22 participants 46 participants
Female
5
  20.8%
4
  18.2%
9
  19.6%
Male
19
  79.2%
18
  81.8%
37
  80.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 participants
Hispanic or Latino
1
   4.2%
1
   4.5%
2
   4.3%
Not Hispanic or Latino
23
  95.8%
21
  95.5%
44
  95.7%
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 24 participants 22 participants 46 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.2%
0
   0.0%
1
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  37.5%
11
  50.0%
20
  43.5%
White
14
  58.3%
9
  40.9%
23
  50.0%
More than one race
0
   0.0%
2
   9.1%
2
   4.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Alcohol Consumption
Hide Description Peak Breath Alcohol Concentration during IV alcohol self-administration
Time Frame 2.5 hr session following 3 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
sample that completed the assessment
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline tablets, 2 mg per day for 3 weeks
Placebo tablets, 0 mg per day for 3 weeks
Overall Number of Participants Analyzed 16 12
Mean (Standard Error)
Unit of Measure: mg/%
92.0  (11.6) 77.3  (13.5)
2.Secondary Outcome
Title Alcohol Urges
Hide Description

Peak Alcohol Urge Questionnaire Score during IV alcohol self-administration. Scale: Alcohol Urge Questionnaire. Contains 8 items, each item scored on a likert scale from 1 to 7.

Range: Total scores range between 8 and 64. Higher scores indicate higher urges for alcohol.

Time Frame 2.5 hr session following 3 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
sample that completed the assessment
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline tablets, 2 mg per day for 3 weeks
Placebo tablets, 0 mg per day for 3 weeks
Overall Number of Participants Analyzed 16 12
Mean (Standard Error)
Unit of Measure: Units on a scale
23.65  (2.74) 26.82  (3.70)
3.Other Pre-specified Outcome
Title BOLD Response to Alcohol Cue
Hide Description Percent BOLD signal change during Alcohol Food Incentive Delay Task (Alcohol - Neutral)
Time Frame fMRI session following 2 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
sample that completed the assessment
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline tablets, 2 mg per day for 3 weeks
Placebo tablets, 0 mg per day for 3 weeks
Overall Number of Participants Analyzed 16 12
Mean (Standard Error)
Unit of Measure: Percent Signal Change
-0.021  (0.051) 0.194  (0.080)
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description Varenicline tablets, 2 mg per day for 3 weeks Placebo tablets, 0 mg per day for 3 weeks
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 (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   21/24 (87.50%)   18/22 (81.82%) 
Cardiac disorders     
Chest pain - cardiac   4/24 (16.67%)  1/22 (4.55%) 
Palpitations   2/24 (8.33%)  4/22 (18.18%) 
Gastrointestinal disorders     
Constipation   7/24 (29.17%)  6/22 (27.27%) 
Diarrhea   6/24 (25.00%)  3/22 (13.64%) 
Flatulence   10/24 (41.67%)  5/22 (22.73%) 
Nausea   14/24 (58.33%)  6/22 (27.27%) 
Stomach pain   6/24 (25.00%)  4/22 (18.18%) 
General disorders     
Irritability   6/24 (25.00%)  4/22 (18.18%) 
Metabolism and nutrition disorders     
Anorexia   6/24 (25.00%)  0/22 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain   11/24 (45.83%)  7/22 (31.82%) 
Pain in extremity   5/24 (20.83%)  6/22 (27.27%) 
Nervous system disorders     
Headache   11/24 (45.83%)  8/22 (36.36%) 
Lethargy   13/24 (54.17%)  11/22 (50.00%) 
Memory impairment   11/24 (45.83%)  9/22 (40.91%) 
Somnolence   7/24 (29.17%)  6/22 (27.27%) 
Psychiatric disorders     
Agitation   1/24 (4.17%)  3/22 (13.64%) 
Anxiety   8/24 (33.33%)  7/22 (31.82%) 
Psychiatric disorders - Other, specify   17/24 (70.83%)  12/22 (54.55%) 
Reproductive system and breast disorders     
Uterine pain   3/24 (12.50%)  1/22 (4.55%) 
Respiratory, thoracic and mediastinal disorders     
Cough   11/24 (45.83%)  8/22 (36.36%) 
Dyspnea   2/24 (8.33%)  2/22 (9.09%) 
Skin and subcutaneous tissue disorders     
Pruritus   4/24 (16.67%)  2/22 (9.09%) 
Indicates events were collected by systematic assessment
The IV alcohol self-administration method may have shown ceiling effects limiting the interpretation of results.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ramchandani, Vijay
Organization: National Institute on Alcohol Abuse and Alcoholism
Phone: +1 301 402 8527
Responsible Party: Vijay Ramchandani, Ph.D., National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00695500     History of Changes
Other Study ID Numbers: 080137
08-AA-0137 ( Other Identifier: NIH Office of Protocol Services )
First Submitted: June 11, 2008
First Posted: June 12, 2008
Results First Submitted: April 5, 2016
Results First Posted: August 15, 2016
Last Update Posted: August 15, 2016