NCT00010907

WithdrawnPhase 2

Preliminary Human Trial of NPI-028

National Center for Complementary and Integrative Health (NCCIH)Source

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Other study identifiers

Sponsor study identifier

P50AT000009-02P1

NIH

Secondary identifiers

5-P50AT00009-3

Study Type

interventional

Actual enrollment (reported)

0

Locations

0 countries

Sites

N/A

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: Not reported
Date not reported
Listed locations: 0 countries · 0 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 2, 2001
Actual (reported)
First Posted
February 5, 2001
Actual (reported)

Last Updated: March 22, 2013
Status Verified: March 2013
Last Update Submitted: March 21, 2013

Conditions

Alcoholism

Interventions

NPI-028Drug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Able to participate as an outpatient
Considered of acceptable health as determined by physical examination

Sponsors & Collaborators

National Center for Complementary and Integrative Health (NCCIH)
NIHlead

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

Milton L. Bullock, MD
Hennepin County Medical Center, Minneapolis
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Purpose: TREATMENT
Sponsor Type: NIH

Study Record Dates

First Submitted

February 2, 2001

First Posted

February 5, 2001

Last Updated

March 22, 2013

Record last verified: 2013-03

Source record

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Source: ClinicalTrials.gov.

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