drugset / Trial / NCT02139761

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

NCT02139761 ↗

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2014-09
Primary completion
2016-06
Completion
2016-06

Outcome

Outcome not reported

Stopped (Business): “Study funding has not been established”

Drugs

EvaluationDrugModalityDoseRoute
Comparator L-tetrahydropalmatine Small molecule 30 mg Oral