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Preliminary Human Trial of NPI-028
This study has been terminated.
Study NCT00010907   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: February 2, 2001   Last Updated: August 17, 2006   History of Changes

February 2, 2001
August 17, 2006
 
 
 
 
Complete list of historical versions of study NCT00010907 on ClinicalTrials.gov Archive Site
 
 
 
Preliminary Human Trial of NPI-028
 

This research will determine whether the Chinese herbal medicine (NPI-028) can make a significant contribution to the management of withdrawal and to follow-up treatment aimed at preventing or managing relapse in both women and men alcoholics. The herbal preparation has been used historically in the treatment of alcohol intoxication and is still prescribed in China and Southeast Asia. Efficacy has been documented but awaits the application of current research methods to establish efficacy, safety, and probable mechanisms of action. Preclinical studies have been carried out in alcohol-preferring rats and vervet monkeys to test efficacy in reducing voluntary alcohol intake, measure tolerance effects, and toxicological affects. The proposed human trial will develop a placebo, establish quality control, test methods of administration, and examine compliance issues. Following these preliminary steps, a placebo controlled trial will be conducted using 160 subjects (80 subjects per treatment condition with 40 of each gender). Alcohol use, craving, health status, psychological status, and at rates will be assessed using established measures that are current in addiction research.

 
Phase II
Interventional
Treatment, Randomized
Alcoholism
Drug: NPI-028
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
160
 
 

Inclusion Criteria:

  • Able to participate as an outpatient
  • Considered of acceptable health as determined by physical examination
  • English speaking/reading
  • Meets DSM-IV criteria for Alcohol Dependence
  • Have at least 10 drinking days in the past month
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00010907
 
P50 AT00009-02P1, 8-P50AT00009-2, 5-P50AT00009-3
National Center for Complementary and Alternative Medicine (NCCAM)
 
Principal Investigator: Milton L. Bullock, MD Hennepin County Medical Center, Minneapolis
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP