New Delhi: Researchers have developed a potential new drug that can treat cannabis addiction without any side-effects.
In the results of clinical trials published in the journal Nature Medicine on 8 June, researchers noted that molecule AEF0117 shows promise in treating cannabis addiction.
According to the article, cannabis is the most widely used recreational substance in the world and 19.5 percent of those who consume it develop cannabis use disorder (CUD), or cannabis addiction. So far, there is no drug or treatment for it.
A diagnosis of severe CUD results in clinical impairment, such as failing to fulfil work or personal obligations, continuing to use cannabis despite it causing persistent problems and unsuccessful efforts to cut down consumption, it states.
A research group at French biotechnology company Aelis Farma developed and tested the molecule AEF0117 and found that it targets the body’s cannabinoid receptor, CB1, and reduces the drug’s effects without triggering any withdrawal symptoms.
According to the article, the active ingredient in cannabis known as tetrahydrocannabinol (THC) stimulates CB1 — a protein that is present in the peripheral nervous system and central nervous system. Once CB1 is activated by THC, it affects feelings of pleasure, motivation, cognition and pain.
Aelis Farma has received €20 million (Rs 177.53 crore) funding for this research from regional investors and through research grants.
Researchers from Canada, New Zealand, Spain, Switzerland, the US and Italy also collaborated with the company.
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How AEF0117 works
AEF0117 blocks the CB1 receptor signaling pathway, which causes the feeling of addiction to cannabis, without affecting the receptor’s fundamental physiological functions.
“AEF0117 is the first of a new pharmacological class of inhibitors that modify the activity of their target receptor in a signaling-specific manner. These drugs reproduce the effects of a natural mechanism to counteract CB1 overactivation,” the researchers wrote.
The authors mentioned data from preclinical studies demonstrating that the drug inhibited THC’s behavioural effects without disrupting normal behaviour or physiological activities in mice and non-human primates.
The researchers also noted a human study consisting of two phases, where they found that AEF0117 significantly decreased the effects of cannabis and the frequency of cannabis use in the participants, without causing any withdrawal symptoms.
In phase 1, AEF0117 was safely administered and well-tolerated in 64 healthy volunteers who consumed the drug once a day, for a week. There were also no observable behavioural changes compared to placebo.
The phase 2a study was conducted with a different set of 29 randomised participants, who smoked cannabis daily, averaging 2-3 grams a day. Over two testing periods which were 5 days long each, participants took capsules of the drug at 9 am every morning and then smoked a controlled amount of cannabis — about 67 mg of THC smoked over 6 minutes.
On a rating form, participants highlighted how they felt after smoking, and were also given opportunities at certain points to purchase additional “puffs”.
An analysis of their responses showed that there was a reduction in ratings expressing how intoxicated they felt, and if there was a “feel good” effect. There was also a reduction in the tendency to buy more “puffs”, as a lower proportion of participants opted for it.
These findings indicate that AEF0117 has the potential to be used for treating CUD without substantial side effects.
The authors note that further trials are still required in larger numbers of volunteers to determine the long-term safety and efficacy of AEF0117, and that a 3-month study in patients seeking treatment for CUD is ongoing.
“Now, we at Aelis are sponsoring a large, placebo-controlled phase 2b study in collaboration with Columbia University Irving Medical Center, enrolling 330 participants with CUD to evaluate three dose levels of AEF0117 in treating cannabis addiction. Results should be available by mid-2024,” Dr Pier Piazza, senior researcher from Aelis Farma, said in a news release.
(Edited by Anumeha Saxena)
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