ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Preliminary Human Trial of NPI-028

This study has been terminated.
Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Preliminary Human Trial of NPI-028
Official Title 
Brief Summary

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.

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Alcoholism
Intervention  Drug: NPI-028
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Terminated
Enrollment  160
Start Date 
Completion Date
Eligibility Criteria 

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
Gender Both
Ages 18 Years to 80 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00010907
Organization ID P50 AT00009-02P1
Secondary IDs †† 8-P50AT00009-2, 5-P50AT00009-3
Study Sponsor  National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators ††
Investigators 
Principal Investigator:     Milton L. Bullock, MD     Hennepin County Medical Center - Minneapolis    
Information Provided By National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date August 2006
First Received Date  February 2, 2001
Last Updated Date August 17, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers