drugset / Trial / NCT02537873

Drug Interaction and Self Administration Studies of Compounds for Cocaine Use Disorder

NCT02537873

RandomizedParallel-groupTriple-blindBasic science

Summary

The overall goal of this project is to develop initial human data on effects of novel compounds on safety (interactions with cocaine) and efficacy (subjective response to cocaine and self administration data) in non-treatment seeking cocaine use disorder subjects. The compound to be studied will be the 5-HT2CR agonist lorcaserin. Lorcaserin and other 5-HT2CR agonists have been shown to reduce cocaine self-administration and cue reactivity in rodents. In addition there is human safety data in non-cocaine using subjects for lorcaserin as it is currently FDA approved for obesity, and safety data from a cocaine interaction study in rodents , but there is no human cocaine interaction/PK data and no PD data to support potential dosages for phase II clinical trials.

Timeline

Start
2015-07
Primary completion
2018-07-19
Completion
2018-07-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Cocaine Small molecule 10 mg Intravenous
Subject Cocaine Small molecule 20 mg Intravenous
Subject Cocaine Small molecule 40 mg Intravenous
Subject Lorcaserin Small molecule 10 mg Oral