drugset / Trial / NCT05282797

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB1 Antagonist ANEB-001 in a THC Challenge Test

NCT05282797 ↗

Phase 2 Completed 154 enrolled Anebulo Pharmaceuticals
RandomizedSequentialQuadruple-blindTreatment

Summary

The aim of this study is to investigate whether ANEB-001 effectively penetrates the brain and inhibits the psychotropic effects of Δ9-Tetrahydrocannabinol (THC), the main psychoactive constituent of cannabis. This randomized, placebo-controlled, double-blind study is designed as a proof-of-pharmacology and dose finding study for the antagonistic effect of ANEB-001 during a THC challenge. Results of this study will inform the future potential use of ANEB-001 as an emergency treatment for acute cannabinoid intoxication.

Timeline

Start
2021-12-15
Primary completion
2023-08-26
Completion
2023-08-26

Outcome

Met primary endpoint

release “Study Met Primary Endpoint VAS Feeling High (p < 0.0001)” anebulo.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject selonabant Small molecule 10 mg Oral
Subject selonabant Small molecule 20 mg Oral
Subject selonabant Small molecule 30 mg Oral

Indications