Preliminary Human Trial of NPI-028

This study has been withdrawn prior to enrollment.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH) Identifier:
First received: February 2, 2001
Last updated: March 21, 2013
Last verified: March 2013
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
Drug: NPI-028
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Enrollment: 0

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00010907

Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Milton L. Bullock, MD Hennepin County Medical Center, Minneapolis
  More Information

No publications provided Identifier: NCT00010907     History of Changes
Other Study ID Numbers: P50 AT00009-02P1, 5-P50AT00009-3
Study First Received: February 2, 2001
Last Updated: March 21, 2013
Health Authority: United States: Federal Government processed this record on December 01, 2015