bypassing the lock...



bypassing the lock...

All clear for the decisive trial of ecstasy in PTSD patients...

MDMA is better known as the party drug ecstasy.

One of the main targets in the war on drugs could well become a drug to treat the scars of war. The U.S. Food and Drug Administration (FDA) has designated 3,4-methylenedioxymethamphetamine (MDMA), better known as the illegal drug ecstasy, a "breakthrough therapy" for posttraumatic stress disorder (PTSD), a status that may lead to faster approval.

The agency has also approved the design for two phase III studies of MDMA for PTSD that would be funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit in Santa Cruz, California. MAPS announced the "breakthrough therapy" designation, made by FDA on 16 August, on its website today; if the group can find the money for the trials, which together could cost an estimated $25 million, they may start next spring and finish by 2021.

That an illegal dancefloor drug could become a promising pharmaceutical is another indication that the efforts of a dedicated group of researchers interested in the medicinal properties of mind-altering drugs is paying dividends. Stringent drug laws have stymied research on these compounds for decades. "This is not a big scientific step," says David Nutt, a neuropsychopharmacologist at Imperial College London. "It's been obvious for 40 years that these drugs are medicines. But it's a huge step in acceptance."

Since 2012, FDA has designated close to 200 drugs as breakthrough therapies, a status that indicates there's preliminary evidence that an intervention offers a substantial improvement over other options for a serious health condition. The agency aims to help develop and review these treatments faster than other candidate drugs.

In people with PTSD, a small sensory trigger such as a sound or a smell can bring a traumatic memory rushing back. "The disabling element of PTSD is the fact that when the memory starts, the emotions completely override you and overwhelm the brain," Nutt says. Studies suggest that MDMA can dampen the emotional response to the memory, allowing people to relive their trauma and work through it, he says. The MDMA-treatment consists of several sessions of psychotherapy, some conducted while the patient is under the influence of the drug.

MAPS Executive Director Rick Doblin set up the group in 1986, one year after the U.S. Drug Enforcement Administration made MDMA an illegal drug, because he was convinced of its therapeutic potential. Since then, MAPS has poured millions into trials of MDMA, for PTSD and other conditions, and has taken the lead in conducting them. The FDA designation is "kind of a public acknowledgement of the promise of this research," Doblin says.

A small U.S. study that first suggested MDMA could help treat PTSD was published in 2011. Since then, researchers in Canada, Israel, and the United States have jointly carried out larger phase II trials funded by MAPS; their results, which remain unpublished but have been reviewed by the FDA, were very good, says Doblin. Overall, 107 participants who had suffered from PTSD for an average of 17.8 years were treated in the phase II trials, Doblin says. Of the 90 patients who were available to be studied 12 months later, 61 no longer had PTSD.

In late July, says Doblin, MAPS and FDA agreed on how the coming phase III trials—usually the last hurdle before seeking a drug's approval from regulators—should be conducted. A key issue that has dogged randomized controlled trials of MDMA and other mind-altering drugs is how to minimize bias. In many trial designs, some patients receive a drug while others are in a control group that receives a placebo. The participants aren't told which they received, but patients who get MDMA can often tell, which might have an effect all by itself.

In past studies, patients in the control arm received a low dose of MDMA—a so-called "active placebo"—that made it harder for them to tell in which group they were. But that had a negative effect on the outcome of their psychotherapy, says Doblin, making MDMA look better by comparison. A low dose "activates people, but it does not provide the fear reduction that the full doses would and so they are more uncomfortable, more unhappy," Doblin says.

That's why FDA decided it would be better to test MDMA-assisted psychotherapy against psychotherapy with an inactive placebo. But the agency and MAPS agreed on additional measures to ensure that the doctors who evaluate the patients don't know if they received the real drug.

The biggest hurdle now is raising the money for the two phase III trials, which together will include between 200 and 300 participants. So far MAPS has raised only $12.75 million, about half of its goal, and an effort to crowdfund the rest has been disappointing. "I think the money will come from major donors," Doblin says. "We are going to people in the tech world and family foundations, but we're also trying with the Veterans Administration." The first phase III trial will start no matter what, he says. "It's always been the philosophy of MAPS that if we can do the work, the money will follow."

MAPS has not conducted trials in Europe yet but is planning to start discussion with the European Medicines Agency, the European Union's regulatory body, soon. Nutt says that after overcoming major regulatory hurdles, he is about to start a trial using MDMA to treat alcohol addiction.

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cancer shrooming...

They were still feeling the benefit six months later

Magic mushrooms, once associated mostly with Phish concerts, may lead to better end-of-life care for cancer patients. One dose of the active ingredient, psilocybin, can help terminal cancer patients experience less depression and anxiety even six months later. Two studies from New York University and Johns Hopkins University confirm a recent wave of research suggesting that hallucinogenic drugs are an important mental health tool.

Cancer patients who took pure psilocybin found it easier to cope with their illness, according to two studies published today in the Journal of Psychopharmacology. The researchers hope to conduct a large trial that might pave the way to US Food and Drug Administration approval for treating the terminally ill with the hallucinogens. (Both studies were funded by the Heffter Research Institute, a nonprofit organization that supports research into hallucinogenic drugs.)

Dinah Bazer participated in the NYU study after being diagnosed with ovarian cancer. "I was totally consumed with anxiety for two years," she says. "It was running my life and ruining my life." The experience of taking psilocybin was incredibly powerful in helping her feel better, she says. She visualized her fear as a physical mass in her body: "I became volcanically angry and screamed 'get the fuck out' and it was gone."

MANY PEOPLE SAID THIS WAS ONE OF THE MOST MEANINGFUL EXPERIENCES OF THEIR LIVES

Drugs like psilocybin, LSD, and MDMA were once used in therapy — famously, even Cary Grant was treated with LSD. But since the 1970s, these drugs have been designated dangerous and tightly controlled substances, which means there hasn't been much research on them. These drugs come with cultural baggage, too, and are often associated with the more radical political beliefs of the '60s. But in recent years, as the War on (some) Drugs subsides, the government has cautiously become more open to using these substances in research. This has caused renewed interest in the clinical potential of these drugs, and the FDA just approved a large-scale study of ecstasy to treat PTSD.

"I'm struck by the difficulty of the research that was accomplished and barriers that persist in researching controlled substances," says Daniel Shalev, a resident psychiatrist at Columbia University Medical Center who was not involved in the studies. "There is a scientific necessity of further research for other controlled substances, including MDMA and cannabis, which are very therapeutic in specific controlled settings."

In the NYU study, researchers assigned 29 patients to receive either a small dose of psilocybin or a placebo that seemed to create a hallucinogenic experience. Both groups received psychotherapy during the sessions, which were about eight hours. These patients had both advanced cancer and what is called "existential distress," essentially anxiety and depression related to their fear of dying. Existential distress isn't just psychologically uncomfortable, says study co-author Stephen Ross, a professor of psychiatry at NYU. People with a lot of existential distress are less likely to survive serious illness. Halfway through the trial, the participants taking psilocybin started taking the placebo and vice versa. The trial was double-blind, which means that neither the patients nor the doctors knew who was taking what. Results from double-blind, controlled, and randomized studies like this one are considered very strong.

Some results were immediate. About 80 percent of the patients were less anxious and depressed by the next day, according to Ross. The participants also reported feeling more spiritually fulfilled and fearing their deaths less. There were still signs of improvement more than six months after the dose.

DOCTORS HAVE LONG STRUGGLED WITH MANAGING EXISTENTIAL DISTRESS

The work from Johns Hopkins showed similar results. This time, there were 51 participants with cancer. They had two sessions five weeks apart. Participants met with clinicians in a room that looked like a living room. They laid down on a couch, used an eye mask, listened to music, and were encouraged to think about their inner experience. In one session, they had a normal dose of psilocybin, and during the other they had a control dose that was too low to have any effect. Again, the patients reported feeling less afraid and more optimistic. Eighty percent of the participants were still feeling benefits after six months, and over half reported the experience as one of the top five most meaningful in their lives, according to study co-author Roland Griffiths, a Johns Hopkins psychiatry professor.

These studies have "extremely exciting" implications for end-of-life care, says Craig Blindeman, director of the Adult Palliative Medicine Service at Columbia University Medical Center. (He wasn't involved in the studies.) Doctors have struggled with managing existential distress, he says, especially because psychotherapy has had mixed results and it can be hard to get treatment due to limitations in mental health coverage. Studies like these could result in psilocybin becoming more widely available, and that could make a big difference for people who are suffering.

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sisters of the valley...

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the best suggested strains...

Marijuana Strains Effects on 5 Common Disorders

If you're new to the legal cannabis market, or find yourself confused by the complex array of products available to you, here's a crash course in medical marijuana. The fundamental characteristics of marijuana are simple enough to wrap your head around. There are two main strains: indica and sativa. Generally speaking, indicas are associated with physical, "body highs," whereas sativas produce "cerebral highs." Then you have hybrids — strains that are bred to enhance specific qualities from each parent strain to produce a desired effect. Cannabis contains at least 85 cannabinoids, ingredients that naturally respond to receptors in your brain and body. That group of receptors is known as the endocannabinoid system, and it's involved in a range of physiological processes such as the regulation of appetite, pain, mood, and memory. While research is limited, most cannabinoids appear to have medical value. Here are the best suggested cannabis strains for five common health conditions.

Pain

ACDC This hybrid strain is famous for its ability to treat generalized pain. While other strains might be better at alleviating certain types of pain — acute, chronic, neuropathic, muscular, and so on — users report that ACDC provides the most effective and instantaneous relief. That's because it's composed of THC (the main psychoactive ingredient in cannabis) and a high concentration of CBD (a non-psychoactive ingredient that has been shown to treat a range of disorders).

Insomnia

Blackberry Kush Pretty much any potent indica is going to do the trick when it comes to treating sleep disorders. High levels of THC help patients fall asleep more quickly, and both THC and CBD have been shown to improve quality of sleep overall. But Blackberry Kush tops the charts as far as insomnia and pain treatment is concerned.

Anxiety

GDP (Granddaddy Purple) A classic indica strain that hails from California, GDP delivers an immediate sense of physical relaxation and euphoria. If you're someone who experiences anxiety or paranoia after smoking, that can often be attributed to the type of cannabis you're using. A heavy indica puts the mind at ease, and Granddaddy Purple is the strain for the job.

Depression

Jack Herer Users report feeling uplifted, creative, and happy after smoking this sativa. The top medical benefits of Jack Herer are stress, depression, pain, and fatigue, according to Leafly. The strain was named after the American cannabis activist Jack Herer, whose written work on the failures of marijuana prohibition are still cited by legalization advocates today.

ADHD/ADD

Blue Dream A recent study found that certain types of marijuana can effectively treat symptoms of attention deficient disorders. Specifically, sativas appear to be the best treatment candidates, as the strain can bolster productivity and focus in some users. Blue Dream, a sativa-dominant hybrid, is a favorite on the west coast, and for qualified medical marijuana patients who have ADHD or ADD, it appears to be a good option. Going into a cannabis dispensary can be an overwhelming experience. There are literally hundreds of strains to choose from (and that's to say nothing about edibles and other offerings) and each affects users in different ways. So if you're a medical patient in any of the 23 states (plus D.C.) that have legalized marijuana for medical or recreational purposes, this guide should help navigate you through your state's medical marijuana system. Marijuana dispensary employees are usually trained to answer your questions about what strains would work best for you, so don't hesitate to ask. And when in doubt, consult the Leafly strain database for detailed information about each strain. [+]

In the next few years, MDMA will be a legal and therapeutic way to get high...

The day after I swallowed MDMA for the first time was almost as magical as the night I had spent on the drug. The world seemed less complicated, and the darkness in my life shrank in comparison to the overflowing afterglow of MDMA's seemingly infinite happiness. What could possibly be wrong with this drug? The answer, as I would learn from countless studies, political-science textbooks and testimonials from long-standing MDMA research, was nothing is wrong with the drug—but how it's accessed and used determines whether it serves as a therapeutic aid, or a death-sentence for fist-pumping yuppies who buy their M from some neck-bearded flub in a parking garage. Rick Doblin, Executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), explains that it isn't MDMA alone that reaps psychological benefits, but rather that professionally-guided psychotherapy is an important component to seeing results. In fact, during a clinical trial, researchers found that MDMA-assisted psychotherapy eliminated the symptoms of PTSD in 83% of patients. This begs the question: why is MDMA illegal in the first place? Of course legalizing a drug impacts public perception, and one argument explores the possibility that regulation would encourage use. And yet, research has indicated that alcohol has an infinitely higher potential to cause bodily harm than pure MDMA. Naturally, swallowing a few pills and drowning your sweat glands at a David Guetta concert isn't the most effective use of MDMA, but it also isn't inherently deadly should the drug be served pure. In Ethics and Public Policy: A Philosophical Inquiry, Jonathan Wolff explains that, "There are many more users of alcohol than ecstasy (MDMA), but even taking this into account alcohol is still, statistically, somewhere in the region of 200 times more likely to kill its users than ecstasy." He then continues to note, "Alcohol is also known to cause brain damage, especially among very high users, yet the evidence that ecstasy has such effects is patchy and contested." MDMA in the pure form and administered in a therapeutic setting has the potential for numerous benefits, which Doblin continues to research and push forward. According to an interview with Huffington Post, MAPS has initiated a "$21 million plan to fund clinical trials and train psychotherapists." In fact, Doblin has already established a training program in Charleston, South Carolina, where a group of 15 is currently training for the position of MDMA/PTSD Psychotherapist. Though medically-prescribed MDMA is a tough concept to get used to, according to a study released by the Journal of Psychopharmacology, trials for MDMA therapy carried "no drug-related serious adverse events, adverse neurocognitive effects or clinically significant blood pressure increases." Furthermore, the journal claims that "MDMA-assisted psychotherapy can be administered to post-traumatic stress disorder patients without evidence of harm." Moving forward with the initiative, Doblin has plans to conduct a number of further clinical trials to demonstrate the capacity of MDMA to relieve PTSD, as well as for a number of other widespread purposes. By 2017, according to Doblin, this will foreseeably gain FDA support and eventually widespread practice. [+]

medical mdma...

This Couple Is Raising $1 Million to Fund Medical-Grade MDMA and Mushrooms

In 2002, Pål-Ørjan Johansen, then a depressed psychology student at the Norwegian University of Science and Technology, ate magic mushrooms for the first time.

It was his first encounter with psychedelics, and according to him, it saved his life.

"It was an experience of biblical dimensions," said Johansen, now a clinical psychologist based in Oslo, Norway. The shrooms—also known as psilocybin—helped him confront his painful past in a way that no other experience had, psychotherapy included, he said.

Today Johansen and his wife, neuroscientist Teri Krebs, are prominent psychedelics researchers and advocates. They believe drugs such as psychedelics and MDMA (ecstasy) have the potential to heal and transform people's lives for the better. Now, they're working to expand access to quality-controlled psilocybin and MDMA around the world.

Pål-Ørjan Johansen and Teri Krebs are working to expand global access to quality-controlled MDMA and psychedelics through their non-profit, EmmaSofia. Image: Tommy Strømmen, EmmaSofia

To support their vision, the pair have turned to crowdfunding. They are running an Indiegogo campaign to fund the large-scale production of medical-grade psilocybin and MDMA through a non-profit they co-founded, called EmmaSofia (Emma, a nickname for MDMA, meaning "universal" and Sofia meaning "wisdom").

Altogether, Krebs and Johansen are looking to raise $1 million. Once they reach $300,000, they will start the process of manufacturing psilocybin. Another $300,000 will allow them to produce MDMA. The remaining $400,000 will support their efforts to decriminalize and reduce harm around MDMA and psychedelic use.

The United Nations classifies MDMA and psilocybin as Schedule I substances, meaning the drugs can only be used for pre-approved scientific and medical purposes. To legally manufacture the drugs, Krebs and Johansen have teamed up with a lab in Oslo that has the licensing to produce MDMA and psilocybin. Due to the sensitivity of the topic, they are not releasing the lab's name.

Teri Krebs and Pål-Ørjan Johansen want to protect the human rights of MDMA and psychedelic users. They believe that people should have the right to privately use the drugs however they choose.

Once the manufacturing process is up and going, EmmaSofia will sell high-quality, "reasonably priced" psilocybin and MDMA to authorized parties, said Johansen.

EmmaSofia also plans to distribute free psilocybin and MDMA to Indiegogo donors based on how much money they gave. In order to receive the drugs, however, donors would have to secure legal permission from their home country—a process that, realistically, will probably only be feasible for a limited number of people.

Krebs and Johansen point out that physicians in the United States can apply for permission from the Food and Drug Administration to prescribe patients experimental and unapproved drugs through a legal pathway called expanded access, or compassionate use.

According to Krebs and Johansen, potential medical uses for psilocybin include treating cluster headaches, obsessive-compulsive disorder, and anxiety related to terminal illness, while MDMA might help treat post-traumatic stress disorder, couples psychotherapy, and Parkinson's disease.

> ### EmmaSofia plans to distribute free psilocybin and MDMA to Indiegogo donors based on how much money they gave

Other experts, however, are skeptical that the FDA will readily grant permission through expanded access. In the United States, MDMA and psilocybin are currently only licensed for use within a small handful of clinical research studies, said Ben Sessa, a psychiatrist and psychedelics researcher based in England.

Sessa fully supports EmmaSofia's efforts, and he himself is fighting to get MDMA taken off the United Kingdom's list of Schedule I drugs. But for now, aside from those clinical trials, Sessa doesn't think people should get their hopes up. "If any clinician dared to prescribe the substances they would be immediately arrested for possession of a Schedule I drug," he told Motherboard.

Johansen and Krebs are currently campaigning to remove MDMA and psychedelics from the United Nations's list of controlled substances. Next April, they will participate in a special session on drugs held by the UN General Assembly.

For Johansen, the work is both universal and deeply personal. MDMA and psychedelics have helped him work through his own emotional hardships. At age 13, he lost three grandparents and his older brother, all in the span of a year. His parents were divorced. More often than not his family was in financial straits. For years, Johansen coped with his traumatic past by abusing alcohol, a tendency that ran in his family.

"With alcohol, you drink and you drink, but you are not really reaching what you want to reach. You are just sort of dampening your problems," he said. "Psychedelics brought me to the place I wanted to be, in an absolute sense."

After his first experience with psilocybin, Johansen took shrooms every Sunday morning for a year. During that time, he stopped abusing alcohol, came to terms with a lot of past pain and shame, and started taking better care of himself.

Teri Krebs and Pål-Ørjan Johansen today with their two daughters. Image: Tommy Strømmen, EmmaSofia

Krebs believes that criminalizing MDMA and psychedelics has done more harm than good. "It's similar to denying people legal access to condoms in order to prevent sexually transmitted disease," she said.

In addition to depriving people of potential therapeutic benefits, said Krebs, outlawing MDMA and psychedelics has created a black market of potentially unsafe homemade products. "Prohibition hasn't worked," she told Motherboard. "People just started manufacturing MDMA in their basements."

Some experts do not share Krebs's and Johansens's enthusiasm for total, unrestricted access to MDMA and psychedelics. There's no question that these drugs can help people examine their lives and confront their fears, said John Rhead, a therapist from Maryland who has used psychedelics with patients in the past.

However, Rhead has also seen psychedelics have damaging impacts, like triggering feelings of suicide. "If you're going to go into very uncharted waters without support, you may encounter things you have no idea how to deal with," he said. As a result, Rhead believes any drug-assisted psychotherapy needs to be limited to supervised sessions.

Johansen and Krebs believe psychedelics are relatively safe, but policymakers have historically focused on worst case scenarios to back up prohibitionist stances. The couple points to multiple studies over the past decade that have ranked psychedelics as less harmful than alcohol. Their own recent research suggests that there is no link between psychedelic use and mental health problems or suicidal behavior.

> ### Johansen took shrooms every Sunday morning for a year

EmmaSofia is not the first organization to take a crowdfunding approach to drug research and production. Last fall another non-profit called the Multidisciplinary Association for Psychedelics Studies raised over $130,000 through Indiegogo to fund the largest-ever clinical trial of MDMA-assisted psychotherapy for post-traumatic stress disorder.

"We predict FDA approval for MDMA-assisted psychotherapy for PTSD by 2021," said Rick Doblin, the founder and executive director of MAPS, in the campaign video.

Crowdfunding is a logical approach for producing MDMA and psychedelics because for-profit companies have no financial incentive to manufacture the drugs, according to Johansen. "The patents for MDMA and psilocybin expired a long time ago, and it's a high cost to start production," he said.

These custom-designed MDMA and psilocybin boxes are among the perks that donors of EmmaSofia's campaign can receive.

Johansen and Krebs are currently on their second Indiegogo campaign. With a month to go, they have already raised over $25,000. Their first campaign, which ended in April, generated over $20,000.

Beyond a source of seed money, crowdfunding provides a platform for EmmaSofia to raise awareness and demonstrate public support around psychedelics and MDMA.

Ultimately, Krebs and Johansen hope that people will be able to go to a store or pharmacy, buy MDMA or psychedelics, and use the drugs freely—whether for cultural activities, spiritual development, or simply for fun and play. To them, it's a matter of personal choice.

"We don't see why people should justify use of MDMA or psychedelics any more than people who do yoga, meditate, enjoy a walk in the woods, or any other activity that they find enriching," said Johansen. "The EmmaSofia project is really about ensuring human rights for people who find it worthwhile to use these drugs."

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smoker, ex-smoker...

charlotte's web...