- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00010907
Preliminary Human Trial of NPI-028
March 21, 2013 updated by: National Center for Complementary and Integrative Health (NCCIH)
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Milton L. Bullock, MD, Hennepin County Medical Center, Minneapolis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
February 2, 2001
First Submitted That Met QC Criteria
February 2, 2001
First Posted (Estimate)
February 5, 2001
Study Record Updates
Last Update Posted (Estimate)
March 22, 2013
Last Update Submitted That Met QC Criteria
March 21, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P50AT000009-02P1 (U.S. NIH Grant/Contract)
- 5-P50AT00009-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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