Following a clinical trial a new drug has shown promise as a safe and effective treatment for cannabis use disorder.
The first-in-class drug has been engineered to selectively inhibit the signalling pathway of the cannabinoid receptor, showing promise as a safe and effective treatment for cannabis use disorder (CUD) in a recent clinical trial.
CUD is defined as the recurrent use of cannabis despite adverse consequences, causing clinically significant impairments or distress.
It is thought to affect 13 million people globally, but as cannabis use becomes increasingly mainstream consumption is on the rise, meaning many more consumers could potentially be at risk.
To date, no medications have been approved by the Food and Drug Administration (FDA) for the treatment of CUD —and evidenced-based behavioural therapies have shown limited benefits.
In a Phase 2a clinical trial, led by Columbia University Irving Medical Center and Aelis Farma, a French biopharmaceutical company, researchers found that the candidate drug, AEFO117, significantly reduced the effects of cannabis in daily cannabis smokers.
According to the researchers, AEF0117 appears to counteract the ‘high’ associated with THC, the primary psychoactive component of cannabis, at the type 1 cannabinoid receptors—the CB1 receptors—without disrupting the receptors’ physiological and behavioural functions, which include memory and learning, emotional processing, sleep, and eating behaviour.
The crossover trial involved 29 participants with CUD who received one of two different doses of AEF0117 in one five day phase and placebo and in another five day phase in randomised order.
AEF0117 was found to significantly reduce participants’ self-reported ratings of cannabis-related positive mood effects, the primary outcome measure, by an average of 38%, while also reducing the use of cannabis.
These reductions occurred without precipitating cannabis withdrawal, even for volunteers who smoked several grams of cannabis per day.
Commenting on the news in a press release, Margaret (Meg) Haney, PhD, supervisor of the phase I studies and principal investigator of the 2a proof-of-concept study, and a professor of neurobiology in the Department of Psychiatry at Columbia, where she is the director of the Cannabis Research Laboratory, said: “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 cannabis by daily smokers.
“Patients seek treatment when they have difficulty controlling their cannabis use despite the problems it is causing at work or in their personal lives. Our findings suggest AEF0117 has great potential for treating problematic cannabis use.”
Culmination of a decade of research
AEF0117, developed by Aelis Farma, is the first of the new pharmacologic class, CB1-SSi, which is based on a unique mechanism of action that enables CB1-SSi to inhibit only the cellular signals involved in CUD.
This breakthrough approach differs from previous CB1 receptor antagonists that, due to their broad blockade of all CB1 receptor activity, caused significant adverse effects preventing their clinical use.
This natural brain mechanism was discovered by the research group of Aelis Farma chief executive officer, Pier Vincenzo Piazza, MD, when he was the director of the Neurocentre Magendie of the French National Institute of Health and Medical Research (INSERM) in Bordeaux.
“The [Nature Medicine] article culminates more than a decade of research, from discovery of this natural brain mechanism to our proof-of-concept clinical trial,” said Dr Piazza.
“We are delighted to contribute to the field of neuropharmacology with a class of drugs never tested in humans before.”
Aelis Farma is currently sponsoring a multi-site, placebo-controlled phase 2b study in collaboration with Columbia’s medical centre.
Frances R Levin, MD, the Kennedy-Leavy Professor of Psychiatry and chief of the Division on Substance Use Disorders at Columbia, is running the two-year study, which is expected to enrol 330 participants with CUD to evaluate three dose levels of AEF0117 in treating cannabis addiction.
She commented: “I am so grateful for our team in the Cannabis Research Laboratory at Columbia Psychiatry for their contributions to running these studies with AEF0117. We are also grateful to the National Institute of Drug Abuse for their support.”
The report, Signaling-specific inhibition of the CB1 receptor for cannabis use disorder: phase 1 and phase 2a randomized trials was published on 8 June by the journal Nature Medicine. Read the full study here.
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