Preliminary Human Trial of NPI-028

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00010907
First received: February 2, 2001
Last updated: March 21, 2013
Last verified: March 2013

February 2, 2001
March 21, 2013
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Complete list of historical versions of study NCT00010907 on ClinicalTrials.gov Archive Site
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Preliminary Human Trial of NPI-028
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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.

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Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Alcoholism
Drug: NPI-028
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
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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
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NCT00010907
P50 AT00009-02P1, 5-P50AT00009-3
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Milton L. Bullock, MD Hennepin County Medical Center, Minneapolis
National Center for Complementary and Alternative Medicine (NCCAM)
March 2013

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