Preliminary Human Trial of NPI-028

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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NPI-028

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No