Preliminary Human Trial of NPI-028
Primary Purpose
Alcoholism
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
NPI-028
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00010907
First Posted
February 2, 2001
Last Updated
March 21, 2013
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00010907
Brief Title
Preliminary Human Trial of NPI-028
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
NPI-028
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milton L. Bullock, MD
Organizational Affiliation
Hennepin County Medical Center, Minneapolis
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Preliminary Human Trial of NPI-028
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