Ignite Creation Date:
2024-05-06 @ 2:48 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02139761
Status:
WITHDRAWN
Last Update Posted:
2019-11-04
First Post:
2014-04-24
Brief Title:
L-tetrahydropalmatine l-THP Treatment for Cocaine Use Disorder
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
L-tetrahydropalmatine l-THP Treatment for Cocaine Use Disorder
Status:
WITHDRAWN
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study funding has not been established
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cocaine continues to be one of the most widely used substances of abuse around the world In the US an estimated 14 million individuals 05 12 years were current past month cocaine users in 2011 Currently no FDA-approved pharmacologic treatments are available for cocaine addiction thus this remains a serious public health problem without an effective pharmacological treatment A promising lead towards an effective treatment comes from a recent finding that pretreatment with oral l-tetrahydropalmitine l-THP in rats attenuated the cocaine seeking associated with a cocaine challenge while having no motor effects This finding stimulated our group to test the pharmacokinetics and safety of l-THP in a phase I study of people with cocaine use Preliminary findings show l-THP is safe and well tolerated in cocaine users with no adverse interactions with cocaine
This study will test the efficacy and safety of l-THP for abstinence in those with cocaine addiction in a phase II pilot study N24 Secondarily we will examine the effects of these medications on craving
This study will test the efficacy and safety of l-THP for abstinence in those with cocaine addiction in a phase II pilot study N24 Secondarily we will examine the effects of these medications on craving
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None