L-tetrahydropalmatine (l-THP) Treatment for Cocaine Use Disorder
Status:
Withdrawn
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Maryland University of Maryland, Baltimore