Preliminary Human Trial of NPI-028

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Alcoholism

Clinical Trial Details

NCT number	NCT00010907
Study type	Interventional
Source	National Center for Complementary and Integrative Health (NCCIH)
Contact
Status	Withdrawn
Phase	Phase 2

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05054738` - CRP and S&A for Inpatient Veterans	N/A
Completed	`NCT02233738` - Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services	N/A
Completed	`NCT05877807` - Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Completed	`NCT00000437` - Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)	Phase 4
Completed	`NCT00536146` - The Stress-Hormone System in Alcohol-Dependent Subjects	N/A
Terminated	`NCT00890149` - Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults	Phase 2
Completed	`NCT02939352` - The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues	Early Phase 1
Completed	`NCT02179749` - Mifepristone Treatment of Alcohol Use Disorder	Phase 2
Completed	`NCT01553136` - Varenicline Treatment of Alcohol Dependence in Smokers	Phase 2
Terminated	`NCT01408641` - Topiramate for Alcohol Use in Posttraumatic Stress Disorder	N/A
Completed	`NCT01389297` - Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery	N/A
Completed	`NCT00768508` - Combined Pharmacotherapies for Alcoholism	Phase 3
Completed	`NCT01760785` - Valproate for Mood Swings and Alcohol Use Following Head Injury	N/A
Completed	`NCT01113164` - Matching Genotypes and Serotonergic Medications for Alcoholism	Phase 1
Completed	`NCT00127231` - Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women	N/A
Terminated	`NCT02842528` - Cognitive Vulnerability Factors in Alcohol-dependence	N/A
Completed	`NCT00367575` - An Internet-based Intervention for Problem Drinking	N/A
Completed	`NCT00167687` - Prazosin Alcohol Dependence IVR Study	Phase 4
Completed	`NCT00583440` - 12-step Facilitation for the Dually Diagnosed	Phase 1/Phase 2
Completed	`NCT00223639` - New Medications to Treat Alcohol Dependence	Phase 2