Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010907
Status:
WITHDRAWN
Last Update Posted:
2013-03-22
First Post:
2001-02-02
Brief Title:
Preliminary Human Trial of NPI-028
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5-P50AT00009-3 | None | None | None |