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Preliminary Human Trial of NPI-028

This study has been terminated.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00010907
  Purpose

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.


Condition Intervention Phase
Alcoholism
Drug: NPI-028
Phase II

MedlinePlus related topics:   Alcoholism   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:   160

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010907

Sponsors and Collaborators

Investigators
Principal Investigator:     Milton L. Bullock, MD     Hennepin County Medical Center - Minneapolis    
  More Information

Study ID Numbers:   P50 AT00009-02P1, 8-P50AT00009-2, 5-P50AT00009-3
First Received:   February 2, 2001
Last Updated:   August 17, 2006
ClinicalTrials.gov Identifier:   NCT00010907
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders

ClinicalTrials.gov processed this record on September 05, 2008




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