Veriheal

JUNE 29, 2021

In order to legally access other therapies including nature-based options such as psilocybin , you must gain access under a Right to Try law which requires you to have a terminal condition. The FDA refers to this program as the expanded access program on their website. Patients Are Not In This Alone.

Therapy 64

Therapy DEA Patients Clinical Trials 64

SpeedWeed

MAY 15, 2021

A first-of-its-kind Phase 3 clinical trial has found that MDMA-assisted therapy provided meaningful relief from PTSD symptoms in nearly 90 percent of study participants. MAPS is now enrolling participants for a further Phase 3 study that will allow another 50 subjects to access this promising new therapy. Image via.

Clinical Trials 52

Clinical Trials Therapy Treatment DEA 52

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. “Patients will benefit from cGMP-quality therapies in an accessible and efficient format.”. .

DEA 51

DEA Clinical Trials THC Research and Development 51

Veriheal

JUNE 30, 2023

For their analysis, researchers conducted qualitative interviews with 13 individuals who had participated in a psilocybin clinical trial. The 13 individuals were chosen because of their reported improvements in negative drinking behavior following the clinical trial.

Clinical Trials 98

Clinical Trials Research and Development Therapy Policy 98

NewsMunchies

NOVEMBER 12, 2021

In clinical trials, psilocybin (the psychoactive substance in mushrooms) has shown tremendous promise in treating severe depression, post-traumatic stress disorder, and other mental illnesses. Additional clinical trials underway in the U.S. We know such categorization is baseless and false. Rate this blog post.

Clinical Trials 90

Clinical Trials Therapy Decriminalization DEA 90

Canna Law Blog

MARCH 4, 2020

Similar to ketamine, psilocybin has shown great promise in clinical trials for helping to effectively treat depression and PTSD (and we’ve written about psilocybin several times on this blog, including here and here ). That access would be available under the auspices of having a chronic, untreatable mood disorder.

Therapy 116

Therapy Legalization Chronic Pain DEA 116

Veriheal

APRIL 11, 2022

We know that the plant has powerful potential medical effects, but it clearly needs more refinement, more research and more data,” stated Groff, who envisions a future where patients can easily access ailment-targeted cannabis meds. Drug Enforcement Agency (DEA). This means that U.S.

Pharmaceutical 105

Pharmaceutical Research and Development DEA Clinical Trials 105

Cannabis Law Report

OCTOBER 20, 2021

Bank of America (BoA) is reportedly terminating its banking relationship with Scottsdale Research Institute (SRI), a DEA-registered facility that carries out important marijuana research. The quality of this cannabis had been criticised by a number of researchers, including Dr. Sisley.

Banking 52

Banking Clinical Trials DEA History 52

MedicalJane

JUNE 29, 2018

Use of CBD in seizure prevention is well-documented with research ; and now, after conducting its own trials, the FDA appears to agree. Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome.

Clinical Trials 53

Clinical Trials CBD DEA Research and Development 53

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.

Therapy 52

Therapy Patients Law Clinical Trials 52

Cannabis Law Report

JULY 9, 2021

Then, in November 2019, the FDA granted the designation to the nonprofit Usona Institute to study psilocybin’s effect on major depressive order, for which clinical trials are currently under way. See Usona Institute, A Study of Psilocybin for Major Depressive Disorder (MDD) , Clinical Trial ID NCT03866174, available at [link].

Law 81

Law Therapy Clinical Trials Research and Development 81

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. The Drug Enforcement Agency (DEA) currently has guidance published for those interested in petitioning for a religious exemption to the CSA. Schedule I.

Clinical Trials 52

Clinical Trials Legalization Therapy Decriminalization 52

Cannabis Law Report

APRIL 21, 2022

The availability of larger quantities of cGMP-compliant MDMA will facilitate ongoing clinical trials and provide for future therapeutic use following anticipated regulatory approvals. Publication of this process establishes “prior art,” contributing to MAPS’ patient access strategy by making intellectual property public .

Clinical Trials 52

Clinical Trials Research and Development Therapy Media 52

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., Lyle Craker, Ph.D.,

Clinical Trials 52

Clinical Trials Therapy Research and Development DEA 52

The Cannigma

MAY 6, 2021

If you have access to regulated cannabis that’s produced under acceptable standards, there’s no real reason to seek delta-8 products. The Drug Enforcement Administration (DEA) recently issued a clarification on the matter, stating that “All synthetically derived tetrahydrocannabinols remain schedule 1 controlled substances”.

THC 145

THC Cannabinoids Concentrates Hemp 145

Cannabis Law Report

JANUARY 14, 2020

CLICK IMAGE TO ACCESS COMMITTEE INFO PAGE. It would also open up medical marijuana access to veterans, allowing Department of Veterans Affairs health providers to “provide information to veterans about federally-approved cannabis clinical trials, and to participate in such trials if registered under the CSA.”.

Clinical Trials 69

Clinical Trials Programs Access DEA 69

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 ).

Clinical Trials 52

Clinical Trials Research and Development Therapy Treatment 52

Cannabis Law Report

DECEMBER 21, 2021

Numinus also made important alliances in 2021, particularly with the Multidisciplinary Association for Psychedelic Studies (MAPS) on its compassionate access trial for MDMA-assisted therapy. While its psilocybin and MDMA trials progress, the company is expanding its psychedelics research laboratory.

Clinical Trials 52

Clinical Trials Therapy Treatment DEA 52

Veriheal

JUNE 24, 2021

Collins responded that they have made “some progress” but that the schedule 1 listing of the substances causes researchers to have to “overcome significant hurdles to access it”. . However, it is challenging to do this as the scheduling of substances stands in the way of accessing them- even if allocations have been made to do so. .

Research and Development 52

Research and Development Clinical Trials Treatment Access 52

SpeedWeed

DECEMBER 28, 2018

Bummer: Patients Are Still Struggling for Cannabis Access. There’s nothing to justify the sky-high price (about $90 per day) beyond the cost of research and development to win FDA approval. RELATED STORY. 6 International Cannabis Strains Worth Seeking Abroad.

Pharmaceutical 40

Pharmaceutical Research and Development Legalization CBD 40

The Cannigma

JUNE 14, 2021

All that is about to change, thanks to a change at the DEA , which cultivators and industry experts say will be monumental for cannabis research, medical marijuana patients, and potentially the broader legal status of the plant itself. “We Junk’ cannabis ‘ill-suited for clinical trials’. BRC) told The Cannigma this week.

DEA 133

DEA Research and Development Clinical Trials Pharmaceutical 133

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.”

Therapy 98

Therapy Clinical Trials DEA Microdosing 98

Veriheal

JUNE 26, 2025

Photo Credit: iStock With first-line recommended mental health interventions for PTSD treatment failing to eliminate symptoms in an average of 40% of patients in clinical studies, finding alternative effective and accessible treatments for PTSD is an urgent task from both an economic and public health standpoint.

Clinical Trials 52

Clinical Trials Therapy Research and Development Treatment 52

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.

DEA 52

DEA Clinical Trials Policy Research and Development 52

Veriheal

DECEMBER 21, 2022

The Drug Enforcement Administration (DEA) is now mandated to approve applications to be manufacturers of marijuana-derived, FDA-approved drugs under the bill. While both options seem better than the current situation, they could actually make it more difficult to access. The law gives the U.S. Descheduling Cannabis.

Clinical Trials 98

Clinical Trials Marijuana Decriminalization History 98

Veriheal

AUGUST 31, 2020

However, social and economic barriers like racial stereotypes and lack of access to care centers have historically barred Hispanic community members from seeking medical cannabis and participating in clinical trials. Supply chains are disrupted as a result, and consumers grow fearful of buying hemp.

Research and Development 119

Research and Development Education Agriculture Patients 119

Cannabis Law Report

MAY 29, 2022

8] Spravato is derived from ketamine and categorized by DEA as a Schedule III controlled substance. Clinical Trials and Human Subject Protections. Before the drug approval process even begins, sponsors must initiate clinical investigations by first filing an Investigational New Drug Application (IND) with FDA.

Research and Development 52

Research and Development DEA Clinical Trials Therapy 52

Canna Law Blog

MARCH 4, 2020

Similar to ketamine, psilocybin has shown great promise in clinical trials for helping to effectively treat depression and PTSD (and we’ve written about psilocybin several times on this blog, including here and here ). That access would be available under the auspices of having a chronic, untreatable mood disorder.

Legalization 59

Legalization Therapy Chronic Pain DEA 59

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).

DEA 52

DEA Clinical Trials THC Pharmaceutical 52

SpeedWeed

MARCH 18, 2021

for the production of cannabis used in federally-regulated clinical trials. Wasn’t the DEA going to let others grow research-grade cannabis? Early on in the study, criticism over the poor quality and low potency of the NIDA-supplied cannabis prompted Johns Hopkins University to withdraw from the multi-year clinical trials.

Clinical Trials 40

Clinical Trials THC Strains Cannabis 40

Cannabis Law Report

FEBRUARY 28, 2022

Clinical trials are producing promising results, creating enthusiasm for commercializing and patenting psychedelics. Importantly, control of psychedelics by a small number of companies may stifle innovation and reduce access to these therapies. Trial of Psilocybin Versus Escitalopram for Depression , 384 NEW ENG.

Research and Development 52

Research and Development Therapy Law Clinical Trials 52

NORML

SEPTEMBER 20, 2019

We also spoke with her attorneys, who explained why they believed the DEA broke the law by holding up long-promised medical marijuana research licenses. Essentially, the federal government has monopolized cannabis research, and ElSohly’s product, according to some scientists who’ve seen it, is unsuitable for clinical trials.

DEA 229

DEA Research and Development Clinical Trials Patients 229

Canna Law Blog

NOVEMBER 6, 2021

Despite overwhelming evidence that psilocybin is misclassified, this barrier restricts research, stifles competition and innovation, and inhibits access. But only if it is made affordable and accessible. Instead, qualifying evidence may come from adequate and well-controlled clinical trials. For two decades, U.S.

Clinical Trials 98

Clinical Trials DEA Research and Development Therapy 98

Veriheal

NOVEMBER 7, 2024

The Drug Enforcement Administration (DEA) announced in August that a hearing regarding the reclassification decision will take place on December 2, 2024, before an administrative law judge. Then, the DEA will review the report and draft a final ruling, factoring in all relevant information submitted during the public comment period.

DEA 97

DEA Policy Chronic Pain Marijuana 97