Cannabis Law Report

FEBRUARY 10, 2022

Court of Appeals for the Ninth Circuit dismissed a petition for review of a Drug Enforcement Administration (DEA) response to an attorney’s letter seeking advice and guidance on how a physician could administer psilocybin to a terminally ill patient without incurring liability under the Controlled Substances Act (CSA). By Allison Campbell.

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DEA Clinical Trials Policy Research and Development 52

SpeedWeed

JULY 23, 2021

When you’re talking about wanting to do an actual clinical trial, you need a diversity of people that participate and one state just does not have the diversity of people that are required,” Towle said. Denver Company Moves Forward with Research License .

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Clinical Trials Research and Development DEA Cannabinoids 52

The Cannigma

MAY 6, 2021

Other than serving as a lighter version of delta-9-THC, delta-8 has also been researched as a potential treatment for a number of medical conditions and symptoms such as vomiting and nausea, glaucoma, pain, and inflammation. The only clinical trial on delta-8-THC involving humans was done on children in Israel in 1995.

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THC Cannabinoids Concentrates Hemp 145

Cannabis Law Report

MAY 31, 2022

The only psychedelic drug that is approved (outside of clinical trials) for psychiatric use—as opposed to anesthesia—through the traditional medical system is Ketamine. Food and Drug Administration (FDA) approved esketamine (a component of Ketamine and sold under the brand name Spravato) for treatment-resistant depression.

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Clinical Trials Legalization Therapy Decriminalization 52

SpeedWeed

AUGUST 11, 2021

Suicide among veterans is an urgent public health crisis, but it’s solvable if we invest in researching new treatments for pain, depression, and PTSD,” said Sisley in a press statement. This trial will be the second of its kind to be conducted so far, and one that is an FDA- and DEA-regulated double-blind, placebo-controlled study.

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Clinical Trials Research and Development Pharmaceutical DEA 52

Cannabis Law Report

OCTOBER 5, 2021

The drug has previously been used with some success in clinical trials designed to treat depression. These trials typically involve the use of music playlists to support the psychedelic experience. The team now plan to investigate the effect of music on the brain while under the influence of psilocybin using an MRI scanner.

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Clinical Trials Research and Development DEA Therapy 52

Cannabis Law Report

OCTOBER 4, 2021

A multitude of recent clinical trials shows the clear promise of psilocybin for this population suffering from these debilitating conditions. Accordingly, it cannot be prescribed by a physician and it is not legally accessible to those who might benefit from it as a therapeutic treatment. Source: [link].

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Therapy Patients Law Clinical Trials 52

Cannabis Law Report

MARCH 2, 2020

Food and Drug Administration (FDA) granted Breakthrough Therapy designation (BTD) to Compass Pathways ‘ psilocybin therapy for treatment-resistant depression. First up, cannabis has now been scientifically validated as a treatment for two severe forms of childhood epilepsy (more on this in a moment). In 2018, the U.S.

Medicine 59

Medicine Therapy DEA Pharmaceutical 59

The Cannigma

MAY 1, 2023

2 3 As clinical trials around the world proceeded in the late 1960s and 1970s, patients began reporting difficulty tolerating ketamine’s unpleasant hallucinogenic and dissociative properties. Ketamine was approved by the FDA in 1970 and was immediately put to use as an important tool for war medics in the Vietnam War.

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Blood Pressure Chronic Pain Research and Development Clinical Trials 85

Veriheal

AUGUST 31, 2020

Essay: “Integrating Research and Medicine: Cannabis Related Treatment for Neurodegenerative Diseases”. Essay Summary: Nishtha wants to further research into THC treatment for patients suffering from neurodegenerative diseases like Alzheimer’s and epilepsy , both of which cause neuron death. Nishtha Tripathi. Program between St.

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Research and Development Education Agriculture Patients 118

SpeedWeed

MARCH 25, 2021

A long-awaited clinical trial on using cannabis as a treatment for veterans with PTSD has finally been published in the PLOS One journal , but the results are far less promising than researchers and veterans had hoped. million grant from the Multidisciplinary Association of Psychedelic Studies (MAPS).

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DEA Clinical Trials THC Pharmaceutical 52

Veriheal

JUNE 24, 2021

Collins has said that the DEA recently “granted permission to expand the number of research marijuana providers” but that the best solution would still be to remove cannabis from its scheduling and to alter the scheduling of other psychedelics to make the much-needed researcher easier. .

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Research and Development Clinical Trials Treatment Access 52

Weedistry

MARCH 7, 2019

A team of Spanish scientists led by Manuel Guzman conducted the first clinical trial assessing the antitumoral action of THC on human beings. The results were published in 2006 in the British Journal of Pharmacology : THC treatment was associated with significantly reduced tumor cell proliferation in every test subject.

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THC CBD Clinical Trials Research and Development 40

SpeedWeed

MARCH 18, 2021

Preliminary results from a long-awaited study indicate that cannabis appears to be a safe and well-tolerated treatment for patients managing post-traumatic stress disorder (PTSD), although researchers did not find strong signals of effectiveness. for the production of cannabis used in federally-regulated clinical trials.

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Clinical Trials THC Strains Cannabis 40

Cannabis Law Report

JULY 12, 2019

Recent studies on the effectiveness of cannabidiol in the rare seizure disorders Dravet Syndrome and Lennox-Gastaut syndrome have prompted a biopharmaceutical company to perform clinical trials of its own to bring a cannabidiol based drug to the American market through the process of FDA approval. Lancet Neurol Dec 23 2015. Fabricio A.

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Extraction Pharmaceutical CBD Epilepsy 73

SpeedWeed

MARCH 5, 2021

One, they have been determined by the US Food and Drug Administration to be clinically safe and effective treatments for a specific medical condition. Two, they are federally classified by DEA and HHS as Schedule II, III, IV or V substances. Rescheduling cannabis will not necessarily facilitate clinical research.

Business 52

Business Policy Clinical Trials Research and Development 52

Cannabis Law Report

JULY 9, 2021

Not only are more and more jurisdictions decriminalizing the use of psychedelics for recreational purposes, but it appears that psychedelic substances are the new horizon for the treatment of severe psychological disorders and other ailments. Drug Enforcement Agency (“DEA”). Id ; 21 CFR 312.1-10; 10; 312.80-88; 88; 312.300 et seq.

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Law Therapy Clinical Trials Research and Development 81

Canna Law Blog

MAY 7, 2020

Ole Miss got the cannabis study and research cultivation gig from the DEA (via a contract with the National Institute on Drug Abuse (NIDA)) in 1968. for various studies, including FDA-approved clinical trials. In 2016, the DEA finally shifted to different treatment around expanded research efforts into cannabis beyond Ole Miss.

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DEA Research and Development Cultivation Supply Chain 75

Cannabis Law Report

NOVEMBER 22, 2019

MMJ International Holdings, the premier medical cannabis research company, announced that it has received DEA approval to ship THC and CBD from Canada. MMJ will be utilizing its new products for an FDA approved treatment of multiple sclerosis (MS) and Huntington’s disease (HD). Orphan Drug Designation?

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DEA Clinical Trials THC Research and Development 51

SpeedWeed

SEPTEMBER 4, 2021

The DEA published a new document in the Federal Register on September 2 requesting an increase in production for certain Schedule I and Schedule II substances so that it can initiate more research studies. . DEA firmly believes in supporting regulated research of schedule I controlled substances. View original article.

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DEA Research and Development Clinical Trials Extraction 52

Veriheal

APRIL 11, 2022

Drug Enforcement Agency (DEA). According to the company’s CEO, George Hodgin, “federally legal FDA- and DEA-approved cannabis-based drugs will absolutely upend the traditional pharmaceutical market.”. Groff confirmed that it had completed its first batch of medicinal-grade cannabis for research purposes on Feb.

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Pharmaceutical Research and Development DEA Clinical Trials 105

CannaMD

NOVEMBER 15, 2020

research on marijuana harms – such as cannabis withdrawal, treatments for substance abuse and use/exposure during pregnancy or infancy – received 20 times more funding than research on cannabis therapeutics. While some funds are being used to study cannabis medical treatments, the majority of funding is still used to research harms.

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DEA Clinical Trials Cannabinoids Treatment 105

Cannabis Law Report

APRIL 8, 2022

This year, we are completing the second Phase 3 clinical trial of MDMA-assisted therapy for PTSD , the final stage prior to requesting FDA approval for a new prescription treatment to help heal trauma. Later that year, Doblin sued the DEA for the first time. Rick Doblin, Ph.D., and Michael Mithoefer, M.D.,

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Clinical Trials Therapy Research and Development DEA 52

MedicalJane

JUNE 29, 2018

The new drug is indicated for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome. The Next Move Is On The DEA.

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Clinical Trials CBD DEA Research and Development 53

Cannabis Law Report

MAY 29, 2022

Widespread approval for psychedelic treatments remains unlikely, but the tide is slowly turning. In 2019, FDA approved Spravato (esketamine) nasal spray for treatment of depression in adults. [8] 8] Spravato is derived from ketamine and categorized by DEA as a Schedule III controlled substance. Defining Psychedelics.

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Research and Development DEA Clinical Trials Therapy 52

Cannabis Law Report

AUGUST 18, 2022

Smith , a partner with the firm and co-leader of the firm’s Life Sciences & Health Effects Team, will lead the practice, bringing together scientist-attorneys and experienced litigators to support clients that are driving innovation in mental health treatments. Tweet this. However, change appears imminent. ” Joining Ms.

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Therapy Research and Development Pharmaceutical Treatment 52

Cannabis Law Report

APRIL 13, 2022

Complementary businesses combine to create a preeminent North American platform with operations spanning 13 wellness clinics, four research sites and one bioanalytical laboratory. Hosting clinical trials for MDMA ( MAPS Public Benefit Corporation), psilocybin (the Usona Institute), LSD (MindMed) and ketamine (the University of Utah ).

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Clinical Trials Research and Development Therapy Treatment 52

Cannabis Law Report

FEBRUARY 28, 2022

Clinical trials are producing promising results, creating enthusiasm for commercializing and patenting psychedelics. 1025, 1026 (2021) (reporting significant improvement of PTSD symptoms following treatment with MDMA in clinical trial); see also Alec J. Mitchell et al., Divito & Robert F. TIMES (Nov.

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Research and Development Therapy Law Clinical Trials 52

Cannabis Law Report

DECEMBER 21, 2021

This UK-based company caught our attention in 2021 for its team of renowned psychedelic researchers, including chief research officer Professor David Nutt, chief medical officer Dr. Ben Sessa, and head of ketamine psychotherapy Dr. Celia Morgan, as well as its unique studies into ketamine treatment for addiction and gambling addiction.

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Clinical Trials Therapy Treatment DEA 52

Canna Law Blog

MARCH 4, 2020

From 2015 to 2018, the number of clinics increased from 60 to 300; that number is undoubtedly higher today. People are increasingly using ketamine for ailments that resist treatment through traditional pharmaceutical drugs.

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Legalization Therapy Chronic Pain DEA 52

Canna Law Blog

NOVEMBER 6, 2021

The following year, President Richard Nixon declared drug abuse public enemy number one, and in 1973, he formed the Drug Enforcement Administration (DEA). Instead, qualifying evidence may come from adequate and well-controlled clinical trials. Phase I trials should be sufficient, and many have been completed using psilocybin.

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Clinical Trials DEA Research and Development Therapy 98

Canna Law Blog

NOVEMBER 27, 2021

So according to the DEA, its abuse potential is high and it has no medical use. Also, according to the DEA, “the history of human experience probably goes back several hundred years since DMT usage is associated with a number of religious practices and rituals.” MDMA (Ecstasy) Nears FDA Approval for PTSD Treatment.

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Therapy Clinical Trials DEA Microdosing 92

Cannabis Law Report

MARCH 21, 2019

Although the DEA refuses to remove marijuana from the schedule 1 list, the Farm Bill is considered to be the most important victory in the history of U.S. Schedule 1 drugs are substances, chemicals, or drugs considered by the federal government to have no medical use and a high potential for abuse such as heroin, LSD, and ecstasy.

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State Laws Law CBD Legalization 55

SpeedWeed

DECEMBER 28, 2018

There’s nothing to justify the sky-high price (about $90 per day) beyond the cost of research and development to win FDA approval.

Pharmaceutical 40

Pharmaceutical Research and Development Legalization CBD 40

Cannabis Law Report

JANUARY 14, 2020

On top of all that, even as marijuana manufacturing has boomed in the United States, all marijuana research must be done with product sourced from the sole place with a DEA license, the University of Mississippi (apparently their weed is genetically closer to hemp than anything on the modern commercial market). Source: [link].

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Clinical Trials Programs Access DEA 69