L-tetrahydropalmatine (l-THP) Treatment for Cocaine Use Disorder

Status Withdrawn

Clinical Trial Summary

Cocaine continues to be one of the most widely used substances of abuse around the world. In the US, an estimated 1.4 million individuals (0.5%) > 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 (N=24). Secondarily, we will examine the effects of these medications on craving.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Cocaine Use

Clinical Trial Details

NCT number	NCT02139761
Study type	Interventional
Source	University of Maryland, Baltimore
Contact
Status	Withdrawn
Phase	Phase 2
Start date	September 2014
Completion date	June 2016

View Details

See also
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