Clinical Trials Begin for New Pill to Treat Cannabis Use Disorder
Segal Trials, a private network of research centers based in South Florida, has announced the launch of a phase 2B double-blind clinical trial for a new medication developed by Aelis Farma to treat cannabis use disorder (CUD). The announcement was made in a press release on October 5.
Currently, there are no approved pharmacological treatments for people suffering from cannabis use disorder. This randomized, double-blind, parallel-group study could pave the way for significant progress in the treatment of substance use disorders. For the first time, individuals struggling with marijuana misuse may have access to a pill that can help them break the habit.
“Chronic marijuana use can radically impact people’s social and professional lives in many ways, from poor job performance to mood disorders,” said Dr. Rishi Kakar, Chief Scientific Officer and Medical Director at Segal Trials.
The new medication, AEF0117-202, is the first clinical candidate in a new pharmacological class designed for people who use cannabis at least five days a week. The drug acts on the same areas of the brain as THC and can temporarily alter some of the effects of cannabis. The oral medication will be given to one group of study participants, while a second group will receive a placebo.
“Addiction” can mean many different things, ranging from severe physical withdrawal symptoms seen with opioids or alcohol to unhealthy psychological patterns. The study summary describes cannabis withdrawal symptoms as irritability, mood and sleep problems, decreased appetite, cravings, anxiety, and sometimes physical discomfort.
“The potency of cannabis products has increased significantly over the past twenty years, which may have contributed to a rise in cannabis-related side effects,” Dr. Kakar noted. “With no approved medications for treating chronic cannabis use, the Aelis Farma drug could have a significant positive impact on millions of marijuana users seeking to overcome their cannabis dependence.”
The Segal Trials team will conduct the study at their Center for Psychedelic and Cannabis Research, which was specifically built to meet pharmaceutical and regulatory guidelines, providing a structured inpatient environment that ensures both patient safety and comfort.
Segal Trials has already developed 54 FDA-approved drugs and devices. The company states that its research focuses on psychiatry, neurology, addiction, insomnia, infectious diseases, vaccine development, and women’s health.