Preliminary Human Trial of NPI-028

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. Identifier: NCT00010907
Recruitment Status : Withdrawn
First Posted : February 5, 2001
Last Update Posted : March 22, 2013
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: NPI-028 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Primary Purpose: Treatment

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00010907

Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Milton L. Bullock, MD Hennepin County Medical Center, Minneapolis Identifier: NCT00010907     History of Changes
Other Study ID Numbers: P50AT000009-02P1 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2001    Key Record Dates
Last Update Posted: March 22, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders