‘Cannabis Use Disorder’ Pill Clinical Trial To Begin

Segal Trials announced the double-blind clinical trial of a new drug by Aelis Farma to treat cannabis use disorder.

Smoking too much cannabis and it’s beginning to affect your life in negative ways? Pretty soon a drug in capsule form could be the answer, if pharmaceutical drug developers get their way.

South Florida-based clinical research network Segal Trials announced it will conduct a Phase 2B study to investigate a new drug, AEF0117-202, created by Aelis Farma to treat cannabis use disorder (CUD), according to an October 5 press release. It is a randomized, double-blind, placebo-controlled, 4-arm, parallel-group, prospective, multicenter study, determining the efficacy of a drug that reacts to the same receptors as THC.

Under a new pharmacological class of drugs, called sCB1-SSi, AEF0117-202 is the first clinical candidate for the treatment of CUD, which is often defined as the inability to stop using cannabis—even if it’s causing health and social problems.

How much is too much pot? For this study, the criteria to meet CUD is defined as people who consume cannabis at least five times per week or more. To determine if the pill works, the orally administered drug will be given to a group of study participants, and a second group will receive a placebo. Then researchers will begin their work to determine the efficacy of the drug.

Three doses—1.0, 0.3, and 0.1 mg—and a placebo were given to study participants in capsules. “AEF0117 acts in the same parts of the brain as THC (tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of cannabis’s effects,” researchers wrote in the summary. They explained their reasoning in the press release:

“Chronic marijuana use can drastically impact individuals’ social and professional lives in many ways, from poor work or school performance to mood disorders,” said Rishi Kakar, MD, chief scientific officer and medical director at Segal Trials. “This Phase 2B study gets us closer to the prospect of effectively treating people who want to end their reliance on cannabis but don’t have the tools to quit.”

“Addiction” can mean many different things, ranging from severe physical withdrawal symptoms from drugs like opiates or alcohol, or unhealthy psychological patterns. This study’s summary describes cannabis withdrawal symptoms as including irritability, mood and sleep difficulties, decreased appetite, cravings, restlessness, and occasionally physical discomfort.

According to the Centers for Disease Control and Prevention, one study estimated that approximately 3 in 10 people who consume cannabis have CUD. Another study estimated that people who use cannabis have about a 10% likelihood of becoming addicted.

Researchers Blame Potency for Rise in CUD

The rise in dabbing, and better and more powerful concentrates has been pinpointed as the culprit in the rise in cases of cannabis use disorder.

“The potency of cannabis products has increased significantly over the past twenty years,” which may have contributed to the rise of cannabis-related adverse effects,” said Dr. Kakar. “With no approved drugs available to treat chronic cannabis use, Aelis Farma’s drug has the potential to make a significant, positive impact for millions of marijuana users seeking to end their dependence on cannabis.”

The Segal team will conduct the trial at its Center for Psychedelic and Cannabis Research, which was specifically built using pharmaceutical and regulatory feedback to create a structured inpatient environment that ensures both patient safety and patient comfort. 

Interestingly, the team has also worked with psychedelics. Segal Trials also recently announced it was the first in the United States to conduct a large, randomized clinical trial to investigate MM-120 (LSD D-tartrate) to treat Generalized Anxiety Disorder (GAD).

Segal has already succeeded in developing 54 FDA-approved medications and devices. The company says that its trials focus on psychiatry, neurology, addiction, insomnia, infectious diseases, vaccine development, and women’s health.

  1. I am very skeptical about so-called marijuana addiction. After using marijuana for well over 40 years, I feel safe to say that there is no addiction concerns here. Nowadays I use the herb for medical reasons. But even so, I’ve never been a hard user. I take it when I want it, not because I need it. There are times when I may smoke 2 or 3 days in a row or other times I won’t smoke for days or weeks. Basically I can take it or leave it and have never found it addictive. I believe it’s a matter of some weak minded people who say they have to have it no matter what. I am a firm believer in mind over matter.

  2. Biggest crock of shit. Cannabis has been used for 1000’s of years. I suggest a different type of book for those researchers. Todays society and lack of consciousness are to blame. And possibly a missing protein in the human biological system. Align your chakras, fix your aura, build your chi. There’s all the answers you need.

  3. This is mostly overstated garbage of the addictionologists. As for the criteria, many of us use cannabis at least f time a week if not daily. We are not addicted and suffer no withdrawals if go without. As with alcohol, the propensity for addiction is genetic. Only about 8% of users are addiction prone and given cannabis’s health benefits and lack of physical harm — so what? Chances are the medicine is more dangerous than cannabis.

  4. I dont know whether this treatment will work or if it’s even necessary. I do know for sure that I recently had to abruptly quit daily edible use in order to pass a drug test for a pre-employment drug screen. Exactly seven days after quitting I began having night terrors. And I mean absolutely life like, traumatizing nightmares. Several times I freaked my wife out because I was yelling in my sleep. Even after waking it took me a few minutes to be completely aware of my surroundings. For those few minutes I couldn’t tell for sure if I was still dreaming or if I was awake. It was scary stuff. I’m over two months thc free now and my sleep is still not back to normal. I sleep less and have extremely vivid dreams every night. The nightmares have decreased in severity. That type of withdrawal symptom is real for me. Good luck to those deciding to quit.

    1. I agree..it definitely exists..if you’re afflicted you need to smoke a little daily to not be anxious..that’s one test.Whyarent people admitting this..?

  5. I’m skeptical of the standard that anyone who uses cannabis 5x weekly or more suffers from CUD. That would make all medical marijuana patients who use cannabis every day addicts? Yet those dependent on Big Pharma products like SSRIs, benzodiazepines, and antipsychotic tranquilizers are not addicted? I was diagnosed with mild CUD a few years ago. I then got my NJ medical marijuana card, kept my usage the same, and went to the same place and went through the exact same evaluation with the same addiction professional. Apparently receiving my NJMMP cad cured me of my Cannabis use disorder, since my second evaluation concluded I did not suffer from CUD. A miracle cure!

  6. I used marijuana during adolescents years & for most of adulthood. After coming to a matter of fact realization that my life just wasn’t producing any lasting joy, measurable satisfaction or peace. I made a conscience decision to change habits, pivot, reshape and relaunch into a higher awareness of being complete from within. But first, i relocated 950 miles away from my comfort zone (home). There I fell in love with a newly found freedom of expression. My health, wealth and outlook improved exponentially over the next 8 years. And I accomplished more during this time than the previous 25 years of believing and supporting marijuana sales. WOKE

  7. When, not if the drug gets approved, just wait for the government to mandate its use against cannabis users whether you like it or not.
    Does anyone remember the covid vaccines? Just sayin.

  8. Any mis-use of a substance or behavior can be called an addiction, Cannabis is no exception but frequency and dose vary per person and condition and cannot be used as an indicator alone. There is a genetic component to Any addiction behavior that is being ignored, in addition, no one receptor works to cure anything! When any behavior is impeding on your quality of life, a pill has NEVER been the answer. Less Pills – More PILLars of Health – Sad to see big resources going into pill trials and facilities instead of people trials with the whole plant. It’s also sad to see that insurance coverage for mind body and spirit supportive caregiving work is not considered medicine and coverage falls short to be adequate for healing but RX’s will be covered for your “lifetime”.

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