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Drug Candidate Shows Promise in Treating Cannabis Use Disorder
A drug designed to treat cannabis use disorder by selectively inhibiting the signaling pathway of the cannabinoid receptor has shown promise as a safe and effective treatment in a recent clinical trial.
Researchers from Columbia University Irving Medical Center and Aelis Farma, a French biopharmaceutical company, who conducted a Phase 2a clinical trial found that the candidate drug, known as AEFO117, significantly reduced the effectives of cannabis in daily users. Their findings were published in the journal Nature Medicine.
“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,” Margaret (Meg) Haney, PhD, supervisor of the phase I studies and principal investigator of the 2a proof-of-concept study, said in a news release.
“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.”
Dr Haney is a professor of neurobiology and director of the Cannabis Research Laboratory in the Department of Psychiatry at Columbia. She also co-directs Columbia’s Substance Use Research Center.
While cannabis use disorder affects about 14 million individuals in the US, no medications to treat the disorder have been approved by the US Food and Drug Administration (FDA) to date.
AEF0117, developed by Aelis Farma, is the first of a new pharmacologic class, CB1-SSi, which is based on a mechanism of action enabling CB1-SSi to inhibit only the cellular signals involved in cannabis use disorder. It is a breakthrough approach that contrasts with previous CB1 receptor agonists that block all CB1 receptor activity, causing significant adverse effects that prevent clinical use.
The Phase 2a clinical trial, which involved 29 participants with cannabis use disorder, was a randomized, double-blind, placebo-controlled, crossover, multiple-dose-escalation study. 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% and also reduced cannabis use. The reductions occurred without precipitating cannabis withdrawal, even among high-volume cannabis users.
Aelis Farm is now sponsoring a multi-site, placebo-controlled Phase 2b study in collaboration with Columbia. The 2-year study is expected to enroll 330 participants with cannabis use disorder to evaluate 3 dose levels in treatment.
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