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.
Phase:
Phase 2
Details
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)