A drug has shown promise as a safe and effective treatment for cannabis use disorder, according to a phase 2a clinical trial led by the Irving Medical Center from Columbia University (United States) and the French biopharmaceutical company Aelis Farma.
Specifically, the researchers found that this first class drug candidate, designed to selectively inhibit the cannabinoid receptor signaling pathway, significantly reduced the effects of cannabis in daily smokers.
To date, there are no approved medications for the treatment of substance use disorder. cannabisand behavioral therapies have shown limited benefits.
in this new studypublished in the scientific journal ‘Nature Medicine’, researchers have verified that this drug, called AEF0117, seems to counteract the ‘high’ associated with THC, the main psychoactive component of cannabis, at type 1 cannabinoid receptors (CB1 receptors). ) without altering the physiological and behavioral functions of the receptors, including memory and learning, emotional processing, sleep, and eating behavior.
“We have tested more than a dozen potential treatment drugs in our Cannabis Research Laboratoryand this is the first to decrease both the positive effects of cannabis on mood and the decision to use it by daily smokers,” said Meg Haney, principal investigator of the study, and professor of neurobiology in the Department of Columbia Psychiatry, where she is director of the Cannabis Research Laboratory.
As cannabis use becomes more widespread, its use is increasing, along with problem use, which encompasses addiction. The addiction to cannabis is an underestimated risk of cannabis use that affects millions of people around the world. Despite daily use reaching unprecedented levels among adolescents and young adults, many are unaware that cannabis can be addictive.
AEF0117, developed by Aelis Farma, is the first of the new pharmacological class, CB1-SSi, which is based on a unique mechanism of action that only inhibits the cellular signals involved in cannabis addiction. This approach differs from previous CB1 receptor antagonists which, due to their extensive blockade of all CB1 receptor activity, caused significant adverse effects that precluded their clinical use.
This natural brain mechanism was discovered by the research group of the CEO of Aelis Farma, Pier Vincenzo Piazza, when he was director of the Neurocentre Magendie of the National Institute of Health and Medical Research in Bordeaux (France).
“The study culminates more than a decade of research, from the discovery of this natural brain mechanism to our proof-of-concept clinical trial. We are delighted to contribute to the field of neuropharmacology with a class of drugs never before tested in humans”, commented Dr. Piazza.
Phase 2a has included 29 participants with cannabis addiction who received one of two different doses of AEF0117 in a 5-day phase and placebo and in another 5-day phase in randomized order. AEF0117 significantly reduced cannabis-related positive mood effects by an average of 38 percent, while also reducing cannabis use. These reductions occurred without precipitating cannabis withdrawal, even in volunteers who smoked several grams of cannabis per day.