At a glance
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Phase I Drug Interaction and Self Administration Studies of Compounds for Cocaine Use Disorder
In Brief
A Phase 1 clinical trial evaluating Lorcaserin, Cocaine Intravenous (IV), and 1 other intervention for Cocaine Use Disorder. Completed, enrolled 29 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)
Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
Dextrose in gelatin capsule