Tag: psychedelics

Could KETAMINE be secret weapon in war on cancer? Scientists find illegal party drug can destroy tumours

Ketamine could offer hope in the fight against cancer, scientists believe.

Promising laboratory tests showed the horse tranquiliser-cum-party drug could kill tumour cells.

Experts think it might block a receptor which encourages tumours to grow. 

Although not proven to work on humans, the Imperial College London team hope similar results could be seen in further lab studies and among patients.

In-depth studies involving thousands of cancer patients would be needed before ketamine is ever rolled out as a treatment, however, meaning any development is still years away at best.

Ketamine is only licensed in the UK as an anaesthetic but can also be prescribed off-license as a pain killer.

These versions are medical-grade and proven to be safe.  

However, they can still trigger hallucinations, just like the version sold on the streets for as little as £3 a pop. 

Anyone caught in possession of the class B drug faces a five-year prison term and an unlimited fine.

As it stands, surgery, chemotherapy and radiotherapy are the most commonly used cancer treatments.

But researchers around the world are searching for other treatments in a bid to boost care and survival rates, with up to half of people expected to get the disease in their lifetime.

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Most Military Service Members, Veterans And Their Families Support Allowing VA Doctors To Recommend Marijuana And Psychedelics

Active duty military personnel, veterans and their family members support allowing U.S. Department of Veterans Affairs (VA) doctors to recommend medical marijuana and psychedelics to patients if they believe it would provide a benefit, according to results of a survey from Ohio State University (OSU).

Researchers polled service members, veterans, their family members and non-military respondents over a few weeks in late August and early September, the report says. All told, 1,168 individuals participated, including 315 active and veteran military members, 426 members of military families and 427 non-military individuals. The goal was to assess the differing likelihoods across the categories of respondents to support various statements about medical marijuana and psychedelics as available treatment options.

“Given the prevalence of health issues within the veteran community and the need for a wide range of treatment options, some researchers have started to explore whether and how veteran populations should have access to alternative treatment options such as marijuana and psychedelics,” authors wrote in the preprint paper, which was published this month by OSU law school’s Drug Enforcement and Policy Center and has not been peer-reviewed. “Studies of veteran views on these issues, however, have not closely explored how veteran perspectives on certain drug issues compare directly to those in their immediate and broader community.”

The survey participants, drawn from the volunteer American Population Panel, were asked whether they agreed or disagreed with four statements about marijuana and psychedelics:

  1. Marijuana/psychedelics can be an effective treatment for various medical conditions.
  2. A doctor should be legally allowed to recommend marijuana/psychedelics if the doctor believes the patient could benefit from medical marijuana/psychedelics, even without FDA approval.
  3. A doctor should be legally allowed to recommend marijuana/psychedelics, but only after it has received an approval by the U.S. Food and Drug Administration.
  4. Because of the unique hardships and health conditions experienced by veterans, U.S. Veterans Administration doctors should be legally allowed to recommend marijuana/psychedelics to veterans if the doctor believes the patient could benefit from marijuana/psychedelics.

Strong majorities of all three surveyed groups agreed the substances can be effective treatments, with even more sizable proportions saying that Veterans Administration (VA) doctors should be able to legally recommend the substances to patients if they believe they would provide some benefit.

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Biden Signs Defense Bill Requiring Psychedelics Studies Involving Active Duty Military Service Members

President Joe Biden has officially signed a large-scale defense bill that contains provisions to fund clinical trials into the therapeutic potential of psychedelics for active duty military service members.

The president signed the 2024 National Defense Authorization Act (NDAA) into law on Friday, about a week after Congress approved the final deal and sent it to his desk.

Advocates were encouraged to see that bicameral negotiators agreed to maintain the psychedelics research provisions championed by Rep. Morgan Luttrell (R-TX) that were attached to the House version over the summer.

However, House negotiators receded on a separate section to create a medical cannabis pilot program for veterans. A Senate-passed provision to protect people from being denied security clearances due to past marijuana use was also left out of the final bill.

Now the psychedelics reform has been enacted, requiring the Department of Defense (DOD) to establish a process by which service members with post-traumatic stress disorder (PTSD) or traumatic brain injury could participate in clinical trials involving psilocybin, MDMA, ibogaine and 5-MeO-DMT.

The list of covered psychedelics was also expanded to broadly include “qualified plant-based alternative therapies.”

DOD will need to facilitate that process within 180 days of enactment. It can partner with eligible federal or state government agencies, as well as academic institutions to carry out the clinical trials, with $10 million in funding.

Under the legislation as enacted, the defense secretary will need to provide lawmakers with a report within one year of the enactment, and every subsequent year for three years, with information about trial findings and participation.

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California Psychedelics Ballot Measure Could Undermine Marijuana Taxes, State Officials Say

The California Legislative Analyst’s Office (LAO) released its review this week of a prospective ballot initiative to legalize psychedelics, outlining not only the plan’s policy implications but also its potential fiscal impacts on the state—which the report calls “various” and “uncertain.”

The measure, which proponents submitted the final language for earlier this month, would allow adults to legally grow, possess and use substances like psilocybin, LSD, MDMA, DMT, ibogaine and mescaline. A person would need a healthcare practitioner’s recommendations to purchase psychedelics at regulated stores.

As filed, the so-called Psychedelic Wellness and Healing Initiative of 2024 refers to “entheogenic” plants and substances, and it includes cannabis among them.

That approach, LAO said in its review, could cost hundreds of millions of dollars in potential tax revenue to the degree it affects the state’s existing marijuana market.

“If the interpretation and implementation of the measure causes a large share of cannabis businesses and consumers to shift from the existing legal cannabis market to the new market created by the measure,” the report says, “it could result in a net reduction of hundreds of millions of dollars in cannabis-related tax revenue.”

On the other hand, LAO added, the change could in fact lead to more revenue for the state.

“If there is not such a shift, the measure could result in a net increase in tax revenue,” the office said, “as people selling currently illegal entheogenic plants or substances or providing related services could begin doing so legally under state law and therefore pay sales and personal income taxes.”

Analysts noted that the potential increase in tax revenue, however, “is significantly smaller than the potential revenue reduction.”

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New Hampshire Republican Unveils Bill To Legalize Psychedelics For Mental Health And Medical Conditions

A Republican lawmaker in New Hampshire has prefiled legislation for the coming session that would legalize three psychedelic substances—psilocybin, LSD and mescaline—for therapeutic use with a healthcare provider’s recommendation.

The bill, HB 1693, from Rep. Kevin Verville, would create a regulated psychedelics system for registered patients, with alternative treatment centers (ATCs) set up to produce and dispense the substances.

The proposal is modeled after the state’s existing medical cannabis law, under which seven licensed marijuana ATCs currently serve patients. Psychedelics patients would be required to obtain state-issued ID cards, while designated caregivers could purchase and provide the substances to patients.

To access psychedelics, patients would need a recommendation from a licensed physician, advanced practice nurse, physician’s assistant, nurse practitioner or mental health provider. Anyone falsely claiming to be using psychedelics legally under the measure would be subject to a civil violation and $500 fine, in addition to other penalties.

Among the qualifying conditions envisioned for the program are anxiety, depression, PTSD, panic disorder, obsessive-compulsive disorder, social anxiety, body dysmorphia, eating disorders, sleep disorders, substance use disorder, chronic pain, attention deficit, migraines and cluster headaches, postpartum mental illnesses and others.

The proposal would also allow providers to recommend psychedelics for “any novel or emergent illness which is not categorized in the Diagnostic and Statistical Manual of Mental Disorders but is diagnosed by a state licensed mental health professional,” though there would need to be published scientific observations, including self-reports, regarding psilocybin as a treatment for the condition.

The new program would be overseen by the state Department of Health and Human Services—though the measure does not contain appropriations to fund the program’s startup or staff, a legislative description says, noting that fees for patients and ATCs would be necessary to cover those costs.

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RFK, Ramaswamy And Williamson Push Psychedelics Reform On Presidential Campaign Trail

Democratic, Republican and independent 2024 presidential candidates might disagree on many major political issues, but three hopefuls have each recently used their platform on the campaign trail to promote their visions for psychedelics reform.

Marianne Williamson, who is running for the Democratic nomination against incumbent President Joe Biden, has released a comprehensive drug policy platform that broadly condemns prohibition, pledging to legalize “less harmful drugs” including marijuana and psilocybin while providing free access to psychedelic-assisted psychotherapy to treat drug addiction.

Republican candidate Vivek Ramaswamy reaffirmed his more modest position last week, calling for the decriminalization of ayahuasca and ketamine for military veterans suffering from post-traumatic stress disorder (PTSD) to mitigate the suicide crisis.

Meanwhile, Robert F. Kennedy Jr., who left the Democratic primary to run as an independent candidate, is sharing why he’s embraced allowing access to psychedelics for mental health treatment, describing how his son’s experience with ayahuasca helped him process the death of his mother.

It’s a uniquely 2024 commonality among the otherwise divided candidates, underscoring the increased bipartisan interest in exploring the therapeutic potential of psychedelics.

Each candidate had previously expressed support for psychedelics reform, but recent statements and campaign materials add context to how they view the issue and how they envision implementing change if they beat the political odds to get elected to the White House.

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DEA Renews Push To Ban Two Psychedelics After Abandoning Effort Last Year, Prompting Researchers To Fight Back Again

The Drug Enforcement Administration (DEA) is taking another shot at banning two psychedelics after abandoning its original scheduling proposal last year, teeing up another fight with researchers and advocates who say the compounds hold therapeutic potential.

In a notice published in the Federal Register on Wednesday, DEA again proposed placing 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) in Schedule I of the Controlled Substances Act (CSA).

The agency said that its scientific and medical basis for proposing the ban “remains the same” as it was last year, so it’s making an identical argument that the phenethylamine hallucinogens hold high abuse potential with no known medical value. What’s changed in the new notice appears to be related to the administrative process of requesting a hearing challenging the facts or laws governing the scheduling action.

When it withdrew its earlier notice, DEA mentioned that it would be “publishing a new proposed rule using an amended procedure.”

DEA doesn’t explain why the amended procedure was necessary, but it is the case that scientists rallied last year to request a hearing on its DOI and DOC scheduling proposal. The psychedelic research company Panacea Plant Sciences had also filed a motion contesting the policy change, which could’ve resulted in an administrative judge scheduling a hearing.

Unlike the previous notice, this latest filing says that the “decision whether a hearing will be needed to address such matters of fact and law in the rulemaking will be made by the Administrator.” There are suspicions that DEA is effectively complicating the process for outside parties to challenge the proposal.

In any case, Panacea Plant Sciences is again sounding the alarm. Founder and CEO David Heldreth told Marijuana Moment on Friday that the “response to our rallying cry to fight the DEA’s illogical rule making has been amazing.”

“The psychedelic community from lawyers and researchers to community activists and even individual people have really come together in opposition to the DEA prohibition mindset,” he said. “Panacea have had contact with at least 10 groups that want to be involved or support the legal fight against the DEA attempt to criminalize DOI and DOC. These compounds are intrinsically important to researchers and the scientific study of the mind and body.”

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New York Bill Would Create Psilocybin Therapy Pilot Program For 10,000 Military Veterans And First Responders

A New York lawmaker has introduced a bill that would create a pilot program to provide psilocybin therapy to 10,000 people, focusing on military veterans and first responders, while the legislature also considers broader psychedelics reform.

Assemblymember Pat Burke (D), who has championed various psychedelics measures over recent sessions, filed the therapeutic psilocybin pilot program legislation on Wednesday.

It would create the program under the state Department of Health, which would be required to provide funding to cover the therapy and develop training guidelines for professional facilitators. It would need to issue a report on findings and policy recommendations to the governor and legislature every two years after enactment.

A total of 10,000 patients could participate, including veterans and their families, first responders and people who suffer from cluster headaches. They would need to reside in the western region of New York.

The pilot program would end if psilocybin is approved for medical use by the federal Food and Drug Administration (FDA).

“Psilocybin therapy offers serious potential benefits to assist with mental health, but it suffers from a lack of substantial medical testing,” a memo attached to the measure says. “This bill would alleviate that problem by establishing a pilot program to test psilocybin therapy’s effectiveness on mental health.”

“This pilot program would help record the effects of this treatment on their conditions in order to better understand the effects of this new therapy which promises substantial benefits,” it says.

Under the legislation, the health department would be able to enter into agreements with experts, non-profit organizations, universities or other institutions “for the performance of an evaluation of the implementation and effectiveness” of the program.

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CONGRESS IS PUSHING REVOLUTIONARY RESEARCH ON PSYCHEDELIC TREATMENTS FOR THE MILITARY

CONGRESS IS ON track to approve legislation that would mark a significant advance in U.S. policy toward psychedelics. 

Tucked into the National Defense Authorization Act of 2024 is a provision to fund clinical trials using psychedelic substances to treat active duty members of the military.

Section 723 of the NDAA directs the secretary of defense to partner with a federal or state government agency, or an academic institution, to carry out the research. The bill would fund the treatment of members of the military with post-traumatic stress or a traumatic brain injury with a number of psychedelic substances, including MDMA, psilocybin, ibogaine, DMT, and other plant-based alternative therapies (such as ayahuasca).

Research surrounding psychedelics as a possible treatment for post-traumatic stress disorder have slowly grown, and recent studies have shown promising results, with patients benefiting from even just a few treatments including MDMA and psilocybin. Already, the Food and Drug Administration has designated both treatments as “breakthrough therapies”: a special designation given to expedite the research and development into drugs with the potential to treat serious conditions. On Tuesday, MAPS Public Benefit Corporation, which focuses on psychedelic treatments for mental health issues, submitted a new drug application to the FDA for MDMA-assisted therapy for PTSD. The company says it’s the first such submission for any psychedelic-assisted therapy.

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FDA Weighs New Application To Approve MDMA As First-Ever Psychedelic Medicine For PTSD

A psychedelics-focused drug development company is officially asking the Food and Drug Administration (FDA) to review an application to approve MDMA as a prescription medication for the treatment of post-traumatic stress disorder (PTSD).

The MAPS Public Benefit Corporation (MAPS PBC) announced on Tuesday that it submitted the new drug application (NDA) to FDA, requesting an expedited review given that the agency previously designated the psychedelic as a breakthrough therapy.

If the NDA is ultimately approved, the Drug Enforcement Administration (DEA) would then need to reschedule MDMA accordingly. It would become the first psychedelic in history to be approved as a pharmaceutical, to be administered in tandem with psychotherapy and other supportive services.

MAPS PBC, which is a wholly owned subsidiary of the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), said it provided FDA with copious scientific data derived from multiple clinical trials that supported the efficacy of MDMA as a therapeutic for moderate and severe PTSD.

“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” Amy Emerson, CEO of MAPS PBC, said in a press release.

“If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health,” she said.

MAPS published the results of a recent Phase 3 trial in the journal Nature in September, finding that MDMA “significantly attenuated PTSD symptomology versus placebo with therapy.”

FDA in 2017 designated MDMA as a “breakthrough therapy” based on previous MAPS-sponsored trials. In total, the organization says findings from 18 of its Phase 2 and Phase 3 trials formed the basis of the NDA submitted to FDA.

Because the agency has already recognized the significant therapeutic potential of the psychedelic, MAPS PBC asked it to grant their application a priority review. FDA has 60 days to decided whether it will accept the NDA and whether it will grant priority status for a six-month review or the standards 10-month review.

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