NEW YORK — A groundbreaking drug designed to combat cannabis use disorder (CUD) has shown remarkable potential in a Phase 2a clinical trial conducted by researchers from Columbia University Irving Medical Center and Aelis Farma, a French biopharmaceutical company. The drug, AEFO117, significantly reduced the effects of using marijuana among daily smokers and offers a safe and effective treatment option for individuals struggling with CUD.
What is AEF0117?
AEF0117, developed by Aelis Farma, belongs to a new pharmacologic class called CB1-SSi. The drug targets the type 1 cannabinoid receptors, known as CB1 receptors. It counteracts the psychoactive effects of THC, the primary component of cannabis, without interfering with the receptors’ vital functions related to memory, learning, emotions, sleep, and eating behavior.
Dr. Margaret (Meg) Haney, supervisor of the study and professor of neurobiology at Columbia’s Department of Psychiatry, expressed excitement about the drug’s potential.
“We have tested over a dozen potential treatment medications in our Cannabis Research Laboratory, and this is the first to decrease both the positive mood effects of cannabis and the decision to use it by daily smokers. AEF0117 has great potential for treating problematic cannabis use,” Haney says in a university release.
As cannabis use becomes increasingly popular, particularly with the legalization of the drug in many states, cannabis use disorder has become a growing concern. Around 14 million individuals in the United States are affected by this disorder, even though many are unaware of the addictive nature of cannabis. Unfortunately, there are currently no FDA-approved medications to treat cannabis use disorder, and traditional behavioral therapies have limited success rates.
“The article culminates more than a decade of research, from the discovery of this natural brain mechanism to our proof-of-concept clinical trial,” says Aelis Farma CEO Dr. Pier Vincenzo Piazza. “We are delighted to contribute to the field of neuropharmacology with a class of drugs never tested in humans before.”
Exciting trial results creating big expectations
The Phase 2a crossover trial included 29 participants with CUD who received either one of two different doses of AEF0117 or a placebo. The drug significantly reduced participants’ self-reported ratings of cannabis-related positive mood effects by an average of 38 percent, while also reducing their cannabis use. Notably, there were no withdrawal symptoms reported, even among volunteers who consumed several grams of cannabis daily.
Aelis Farma is currently sponsoring a placebo-controlled Phase 2b study in collaboration with Columbia’s medical center, led by Dr. Frances R. Levin. This two-year study aims to evaluate the effectiveness of three dose levels of AEF0117 in treating cannabis addiction and is expected to enroll 330 participants with CUD.
The study is published in the journal Nature.
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The last drug they developed for the cb1 receptor had to be removed from the market (it was for weight loss it was called rimonabant )because it caused universal suicidal ideation. No thanks.
Legalization of weed does not cause child overdoses. Stuped and careless parents cause child overdoses.
Why do people blame the uncontrollable things rather than blame the controllable things that they can change? So they don’t feel guilt.