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A Pilot Clinical Trial of Varenicline as a Treatment for Alcohol Dependence

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ClinicalTrials.gov Identifier: NCT01011907
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : February 25, 2013
Last Update Posted : February 25, 2013
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Basic Science
Condition Substance Dependence
Interventions Drug: varenicline
Drug: placebo
Enrollment 99
Recruitment Details  
Pre-assignment Details 99 subjects were consented of which 64 successfully completed the screening process were randomized to treatment. Results are posted for the 35 subjects who completed the study.
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description

Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).

varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).

Period Title: Overall Study
Started 31 33
Completed 17 18
Not Completed 14 15
Reason Not Completed
Withdrawal by Subject             13             11
Adverse Event             1             4
Arm/Group Title Placebo Varenicline Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 17 18 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 18 participants 35 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
18
 100.0%
35
 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 17 participants 18 participants 35 participants
Female
8
  47.1%
9
  50.0%
17
  48.6%
Male
9
  52.9%
9
  50.0%
18
  51.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 18 participants 35 participants
17 18 35
1.Primary Outcome
Title Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12.
Hide Description [Not Specified]
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description:

Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).

varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).

Overall Number of Participants Analyzed 17 18
Mean (Standard Error)
Unit of Measure: cigarettes
788.94  (96.27) 403.24  (102.42)
2.Secondary Outcome
Title Average Number of Alcoholic Drinks Consumed Between the Varenicline and Placebo Groups for Completers of the Study Through Week 12.
Hide Description [Not Specified]
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description:

Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).

varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).

Overall Number of Participants Analyzed 17 17
Mean (Standard Error)
Unit of Measure: drinks
277.5  (41.9) 177.04  (28.86)
3.Secondary Outcome
Title Alcohol Craving as Measured by the Obsessive Compulsive Drinking Scale (OCDS) Between Varenicline and Placebo Groups for Completers of the Study.
Hide Description Higher scores on the OCDS indicate increased craving. OCDS possible score range = 0 - 40. Difference in average OCDS scores from week 1 to week 12 were reported for the varenicline and placebo groups in subjects that completed the study.
Time Frame Week 1 to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description:

Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).

varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).

Overall Number of Participants Analyzed 17 18
Mean (Standard Error)
Unit of Measure: Scores on a scale
-3.07  (0.389) -4.36  (0.205)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description

Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).

varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).

All-Cause Mortality
Placebo Varenicline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Varenicline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/31 (3.23%)      0/33 (0.00%)    
Psychiatric disorders     
Suicidal ideation   1/31 (3.23%)  1 0/33 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Varenicline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/33 (0.00%)    
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: Jennifer Mitchell, Clinical Project Director
Organization: UCSF: EGCRC
Phone: 510-985-3100
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01011907     History of Changes
Other Study ID Numbers: EGCRC0109
RC2AA019429 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2009
First Posted: November 11, 2009
Results First Submitted: January 14, 2013
Results First Posted: February 25, 2013
Last Update Posted: February 25, 2013