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Preliminary Human Trial of NPI-028

NCT00010907 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-03-22

No results posted yet for this study

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.

Conditions

  • Alcoholism

Interventions

DRUG

NPI-028

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    lead NIH

Principal Investigators

  • Milton L. Bullock, MD · Hennepin County Medical Center, Minneapolis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00010907 on ClinicalTrials.gov