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Trial record 19 of 1597 for:    veterans affairs medical center

N-acetylcysteine in Alcohol Dependence

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: NCT00568087
Recruitment Status : Completed
First Posted : December 5, 2007
Results First Posted : November 1, 2013
Last Update Posted : November 1, 2013
Sponsor:
Collaborator:
Minnesota Veterans Medical Research and Education Foundation
Information provided by (Responsible Party):
Gihyun Yoon, Minneapolis Veterans Affairs Medical Center

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: N-acetylcysteine
Drug: Placebo
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title N-acetylcysteine Placebo
Hide Arm/Group Description N-acetylcysteine daily for 8 weeks Identical placebo daily for 8 weeks
Period Title: Overall Study
Started 22 24
Received Intervention 21 23
Completed 15 17
Not Completed 7 7
Arm/Group Title N-acetylcysteine Placebo Total
Hide Arm/Group Description N-acetylcysteine daily for 8 weeks Identical placebo daily for 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 22 24 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 24 participants 46 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
23
  95.8%
45
  97.8%
>=65 years
0
   0.0%
1
   4.2%
1
   2.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 24 participants 46 participants
50.1  (11.3) 56.5  (7.0) 53.5  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 24 participants 46 participants
Female
2
   9.1%
2
   8.3%
4
   8.7%
Male
20
  90.9%
22
  91.7%
42
  91.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 24 participants 46 participants
22 24 46
1.Primary Outcome
Title Alcohol Consumption (Percentage of Heavy Drinking Days)
Hide Description The percentage of heavy drinking days was primary a priori outcome measure. Heavy drinking was defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks for women. One standard drink is any drink containing about 0.6 fluid ounces or 14 grams of pure alcohol. The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). At each week, the percentage of HDD was calculated during the period (usually 7 days) since the last previous visit.
Time Frame The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All 44 subjects who received intervention were included in analysis.
Arm/Group Title N-acetylcysteine Placebo
Hide Arm/Group Description:
N-acetylcysteine daily for 8 weeks
Identical placebo daily for 8 weeks
Overall Number of Participants Analyzed 21 23
Mean (Standard Error)
Unit of Measure: percentage of heavy drinking days
Percentage of heavy drinking days at week 1 70.2  (7.1) 58.4  (6.7)
Percentage of heavy drinking days at week 9 20.2  (8.6) 14.7  (5.5)
2.Secondary Outcome
Title Liver Function Tests
Hide Description [Not Specified]
Time Frame 8 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Alcohol Craving (Penn Alcohol Craving Scale)
Hide Description

Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).

The Penn Alcohol Craving Scale (PACS) is a self-rated scale designed to assess alcohol craving. The score range of the PACS is between 0 and 30, with 30 assigned to the highest (worst) alcohol craving.

Time Frame Alcohol craving (Penn Alcohol Craving Scale) was measured at each weekly visit during the 8 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-acetylcysteine Placebo
Hide Arm/Group Description:
N-acetylcysteine daily for 8 weeks
Identical placebo daily for 8 weeks
Overall Number of Participants Analyzed 21 23
Mean (Standard Error)
Unit of Measure: units on a scale
Penn Alcohol Craving Scale at week 1 18.1  (1.5) 18.0  (1.3)
Penn Alcohol Craving Scale at week 9 7.2  (1.7) 11.5  (1.3)
4.Secondary Outcome
Title Alcohol Craving (Obsessive Compulsive Drinking Scale)
Hide Description

Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).

The Obsessive Compulsive Drinking Scale (OCDS) is a self-rated scale designed to assess alcohol craving. The score range of the OCDS is between 0 and 56, with 56 assigned to the highest (worst) alcohol craving.

Time Frame Alcohol craving (Obsessive Compulsive Drinking Scale) was measured at each weekly visit during the 8 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-acetylcysteine Placebo
Hide Arm/Group Description:
N-acetylcysteine daily for 8 weeks
Identical placebo daily for 8 weeks
Overall Number of Participants Analyzed 21 23
Mean (Standard Error)
Unit of Measure: units on a scale
Obsessive Compulsive Drinking Scale at week 1 29.0  (1.7) 27.6  (2.1)
Obsessive Compulsive Drinking Scale at week 9 13.8  (2.9) 17.0  (2.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title N-acetylcysteine Placebo
Hide Arm/Group Description N-acetylcysteine daily for 8 weeks Identical placebo daily for 8 weeks
All-Cause Mortality
N-acetylcysteine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
N-acetylcysteine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
N-acetylcysteine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   4/21 (19.05%)   4/23 (17.39%) 
Gastrointestinal disorders     
Flatulence  1/21 (4.76%)  1/23 (4.35%) 
Stomach discomfort  1/21 (4.76%)  1/23 (4.35%) 
Vomiting  1/21 (4.76%)  0/23 (0.00%) 
General disorders     
Increased appetite  0/21 (0.00%)  1/23 (4.35%) 
Flushed face  0/21 (0.00%)  1/23 (4.35%) 
Dizziness  1/21 (4.76%)  0/23 (0.00%) 
Headache  1/21 (4.76%)  0/23 (0.00%) 
Increased urination  1/21 (4.76%)  0/23 (0.00%) 
Anxiety  1/21 (4.76%)  0/23 (0.00%) 
Sweating  0/21 (0.00%)  1/23 (4.35%) 
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
Layout table for Results Point of Contact information
Name/Title: Gihyun Yoon, MD
Organization: Minneapolis VA Health Care System
Phone: 612-467-3996
EMail: Gihyun.Yoon@va.gov
Layout table for additonal information
Responsible Party: Gihyun Yoon, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00568087     History of Changes
Other Study ID Numbers: Protocol #3852-B
First Submitted: December 4, 2007
First Posted: December 5, 2007
Results First Submitted: June 14, 2013
Results First Posted: November 1, 2013
Last Update Posted: November 1, 2013