ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 1538 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
N-acetylcysteine N-acetylcysteine daily for 8 weeks
Placebo Identical placebo daily for 8 weeks

Participant Flow:   Overall Study
    N-acetylcysteine   Placebo
STARTED   22   24 
Received Intervention   21   23 
COMPLETED   15   17 
NOT COMPLETED   7   7 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
N-acetylcysteine N-acetylcysteine daily for 8 weeks
Placebo Identical placebo daily for 8 weeks
Total Total of all reporting groups

Baseline Measures
   N-acetylcysteine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   24   46 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   22   23   45 
>=65 years   0   1   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.1  (11.3)   56.5  (7.0)   53.5  (9.8) 
Gender 
[Units: Participants]
     
Female   2   2   4 
Male   20   22   42 
Region of Enrollment 
[Units: Participants]
     
United States   22   24   46 


  Outcome Measures

1.  Primary:   Alcohol Consumption (Percentage of Heavy Drinking Days)   [ Time Frame: The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks. ]

2.  Secondary:   Alcohol Craving (Penn Alcohol Craving Scale)   [ Time Frame: Alcohol craving (Penn Alcohol Craving Scale) was measured at each weekly visit during the 8 weeks. ]

3.  Secondary:   Alcohol Craving (Obsessive Compulsive Drinking Scale)   [ Time Frame: Alcohol craving (Obsessive Compulsive Drinking Scale) was measured at each weekly visit during the 8 weeks. ]

4.  Secondary:   Liver Function Tests   [ Time Frame: 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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: Gihyun Yoon, MD
Organization: Minneapolis VA Health Care System
phone: 612-467-3996
e-mail: Gihyun.Yoon@va.gov



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