Cobenfy for Cocaine Addiction

This trial aims to determine if Cobenfy can block the effects of cocaine in individuals with cocaine use disorder. Researchers will compare Cobenfy to a placebo to assess its safety and effectiveness. Participants will stay in a clinic for 11 days, taking either Cobenfy or a placebo, and will engage in sessions to observe how Cobenfy affects their response to cocaine. The trial seeks participants who have recently used cocaine, either by smoking or injection, and have tested positive for cocaine use. As a Phase 1, Phase 2 trial, this research focuses on understanding how Cobenfy works in people and measuring its effectiveness in an initial, smaller group.

The trial requires participants to stop regular use of other medications, except for hormone-based contraceptives, daily multivitamins, short-term antibiotics, and antiretrovirals for hepatitis C. If you're taking other medications, you may need to stop them to participate.

Previous studies have shown that the combination of xanomeline and trospium, known as Cobenfy, has received FDA approval for treating another condition, indicating its general safety. Research shows that about 53% of patients experienced at least one side effect, mostly mild to moderate. The most common issues were stomach-related but not serious. This combination caused fewer problems like dry mouth or blurred vision compared to similar treatments. Overall, Cobenfy is generally well-tolerated, making it a promising option for further study.¹²³⁴⁵

Cobenfy is unique because it combines xanomeline and trospium, two components that aren't typically used together for cocaine addiction. Most current treatments focus on behavioral therapy and medications like naltrexone, which aim to reduce cravings and withdrawal symptoms. However, Cobenfy offers a different approach by potentially altering brain chemistry to decrease the rewarding effects of cocaine. Researchers are excited about this because it could offer a new, more effective way to treat cocaine addiction, helping to reduce relapse rates.

This trial will compare Cobenfy, a mix of xanomeline and trospium, with a placebo for treating cocaine addiction. Research has shown that Cobenfy effectively treats schizophrenia in real-world settings. The FDA has approved this combination, which works in a new way to ease symptoms without causing strong side effects. While primarily used for schizophrenia, Cobenfy might also help reduce the effects of cocaine. Early studies suggest it could alleviate symptoms without the usual side effects. However, further research is needed to confirm its effectiveness for cocaine addiction.¹²³⁵⁶