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‘Cannabis Use Disorder’ Pill Clinical Trial To Begin

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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.

Source: https://hightimes.com/news/cannabis-use-disorder-pill-clinical-trial-to-begin/

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New Mexico cannabis operator fined, loses license for alleged BioTrack fraud

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New Mexico regulators fined a cannabis operator nearly $300,000 and revoked its license after the company allegedly created fake reports in the state’s traceability software.

The New Mexico Cannabis Control Division (CCD) accused marijuana manufacturer and retailer Golden Roots of 11 violations, according to Albuquerque Business First.

Golden Roots operates the The Cannabis Revolution Dispensary.

The majority of the violations are related to the Albuquerque company’s improper use of BioTrack, which has been New Mexico’s track-and-trace vendor since 2015.

The CCD alleges Golden Roots reported marijuana production only two months after it had received its vertically integrated license, according to Albuquerque Business First.

Because cannabis takes longer than two months to be cultivated, the CCD was suspicious of the report.

After inspecting the company’s premises, the CCD alleged Golden Roots reported cultivation, transportation and sales in BioTrack but wasn’t able to provide officers who inspected the site evidence that the operator was cultivating cannabis.

In April, the CCD revoked Golden Roots’ license and issued a $10,000 fine, according to the news outlet.

The company requested a hearing, which the regulator scheduled for Sept. 1.

At the hearing, the CCD testified that the company’s dried-cannabis weights in BioTrack were suspicious because they didn’t seem to accurately reflect how much weight marijuana loses as it dries.

Company employees also poorly accounted for why they were making adjustments in the system of up to 24 pounds of cannabis, making comments such as “bad” or “mistake” in the software, Albuquerque Business First reported.

Golden Roots was fined $298,972.05 – the amount regulators allege the company made selling products that weren’t properly accounted for in BioTrack.

The CCD has been cracking down on cannabis operators accused of selling products procured from out-of-state or not grown legally:

Golden Roots was the first alleged rulebreaker in New Mexico to be asked to pay a large fine.

Source: https://mjbizdaily.com/new-mexico-cannabis-operator-fined-loses-license-for-alleged-biotrack-fraud/

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Marijuana companies suing US attorney general in federal prohibition challenge

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Four marijuana companies, including a multistate operator, have filed a lawsuit against U.S. Attorney General Merrick Garland in which they allege the federal MJ prohibition under the Controlled Substances Act is no longer constitutional.

According to the complaint, filed Thursday in U.S. District Court in Massachusetts, retailer Canna Provisions, Treevit delivery service CEO Gyasi Sellers, cultivator Wiseacre Farm and MSO Verano Holdings Corp. are all harmed by “the federal government’s unconstitutional ban on cultivating, manufacturing, distributing, or possessing intrastate marijuana.”

Verano is headquartered in Chicago but has operations in Massachusetts; the other three operators are based in Massachusetts.

The lawsuit seeks a ruling that the “Controlled Substances Act is unconstitutional as applied to the intrastate cultivation, manufacture, possession, and distribution of marijuana pursuant to state law.”

The companies want the case to go before the U.S. Supreme Court.

They hired prominent law firm Boies Schiller Flexner to represent them.

The New York-based firm’s principal is David Boies, whose former clients include Microsoft, former presidential candidate Al Gore and Elizabeth Holmes’ disgraced startup Theranos.

Similar challenges to the federal Controlled Substances Act (CSA) have failed.

One such challenge led to a landmark Supreme Court decision in 2005.

In Gonzalez vs. Raich, the highest court in the United States ruled in a 6-3 decision that the commerce clause of the U.S. Constitution gave Congress the power to outlaw marijuana federally, even though state laws allow the cultivation and sale of cannabis.

In the 18 years since that ruling, 23 states and the District of Columbia have legalized adult-use marijuana and the federal government has allowed a multibillion-dollar cannabis industry to thrive.

Since both Congress and the U.S. Department of Justice, currently headed by Garland, have declined to intervene in state-licensed marijuana markets, the key facts that led to the Supreme Court’s 2005 ruling “no longer apply,” Boies said in a statement Thursday.

“The Supreme Court has since made clear that the federal government lacks the authority to regulate purely intrastate commerce,” Boies said.

“Moreover, the facts on which those precedents are based are no longer true.”

Verano President Darren Weiss said in a statement the company is “prepared to bring this case all the way to the Supreme Court in order to align federal law with how Congress has acted for years.”

While the Biden administration’s push to reschedule marijuana would help solve marijuana operators’ federal tax woes, neither rescheduling nor modest Congressional reforms such as the SAFER Banking Act “solve the fundamental issue,” Weiss added.

“The application of the CSA to lawful state-run cannabis business is an unconstitutional overreach on state sovereignty that has led to decades of harm, failed businesses, lost jobs, and unsafe working conditions.”

Source: https://mjbizdaily.com/marijuana-companies-suing-us-attorney-general-to-overturn-federal-prohibition/

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Alabama to make another attempt Dec. 1 to award medical cannabis licenses

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Alabama regulators are targeting Dec. 1 to award the first batch of medical cannabis business licenses after the agency’s first two attempts were scrapped because of scoring errors and litigation.

The first licenses will be awarded to individual cultivators, delivery providers, processors, dispensaries and state testing labs, according to the Alabama Medical Cannabis Commission (AMCC).

Then, on Dec. 12, the AMCC will award licenses for vertically integrated operations, a designation set primarily for multistate operators.

Licenses are expected to be handed out 28 days after they have been awarded, so MMJ production could begin in early January, according to the Alabama Daily News.

That means MMJ products could be available for patients around early March, an AMCC spokesperson told the media outlet.

Regulators initially awarded 21 business licenses in June, only to void them after applicants alleged inconsistencies with how the applications were scored.

Then, in August, the state awarded 24 different licenses – 19 went to June recipients – only to reverse themselves again and scratch those licenses after spurned applicants filed lawsuits.

A state judge dismissed a lawsuit filed by Chicago-based MSO Verano Holdings Corp., but another lawsuit is pending.

Source: https://mjbizdaily.com/alabama-plans-to-award-medical-cannabis-licenses-dec-1/

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