Acidmath Digest

MDMA Breakthrough Therapy Designation Results Published
May 13, 2019

MDMA Breakthrough Therapy Designation Results Published


MDMA combined with psychotherapy is a promising treatment for PTSD and is currently under investigation in a phase 3 trial. Data from six phase 2 studies supported a Breakthrough Therapy designation by the FDA. Results are now published in Psychopharmacology.


The Multidisciplinary Association for Psychedelic Studies (MAPS) published results in Psychopharmacology [1] from six phase 2 clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), a mental disorder that can occur after a traumatic event. Symptoms include avoidance of trauma-associated places or people, negative feelings, hypervigilance and intrusive thoughts or memories. The paper describes outcomes from 103 study participants, which represents the largest sample to be published to date. These data were the basis for FDA granting a Breakthrough Therapy designation for this innovative treatment approach.

Six clinical trials were carried out from 2004-2017 at five study sites. These sites were United States (South Carolina, Colorado), Canada, and Israel. The studies enrolled people with moderate to severe chronic PTSD who had failed to adequately respond or tolerate medications and/or psychotherapies. Approximately half of patients (40-60%) do not experience significant PTSD symptom reductions from currently available medications (Zoloft and Paxil) and psychotherapies used to treat PTSD [2, 3].

For the MDMA trials, participants start treatment by undergoing three non-drug psychotherapy sessions (90 mins). Then they receive either active doses of MDMA (75-125 mg) or placebo/control doses of MDMA (0-40 mg) during 2 to 3 psychotherapy sessions that lasted for 8 hours. A male/female co-therapy team was present during all sessions, offering a supportive presence and non-directive psychotherapy. They helped create and maintain a “container” or safe space for the therapeutic experience. Because the studies were blinded, the study participants and therapy team did not know what dose they were given. Three non-drug integration sessions, when participants worked to address and bring together, or integrate, material from the MDMA-psychotherapy sessions, followed each MDMA session – one the morning after the MDMA session, and the other two during the month proceeding the next drug-assisted session.

Remarkably, the results showed that active doses of MDMA more than doubled the effect of psychotherapy alone (or with low doses of MDMA used as placebo controls). On the Clinician Administered PTSD Scale (CAPS-IV), scores dropped on average of -32.4 for the MDMA group and -10.4 for the placebo control group after two MDMA sessions. More participants in the active dose group (54.2%) did not meet criteria for PTSD compared to the control group (22.6%). PTSD symptoms significantly improved further after the third MDMA session, with an additional score reduction on average of -12.9.

PTSD Symptoms Improve Significantly More for Participants who Received MDMA (75-125 mg) during Psychotherapy

All doses of MDMA were well tolerated in the studies. The adverse events (undesirable effects) that occurred at greater frequency for the active MDMA group were anxiety, dizziness, jaw clenching/tight jaw, lack of appetite, and nausea. Most were mild to moderate, causing little interference with daily functioning, and resolved by the end of the session or during the week following. There were no reports or treatment discontinuation during the trial related to problematic substance use of “ecstasy” (pills that contain MDMA and other substances), supporting the low potential for developing substance use problems from taking limited doses of MDMA in a clinical setting. See the MDMA Investigator’s Brochurefor all safety information from MDMA clinical trials and reviews of the scientific literature.

What happens during MDMA-assisted psychotherapy?

The treatment approach is described in the Manual for MDMA-assisted Psychotherapy [4], built on practices that emerged during the first wave of psychedelic explorations in therapeutic contexts in the 1950-70s. As with all psychedelics, the person’s mind set and the environment where MDMA is taken, also known as set and setting, influence how a person feels and perceives the experience. For MDMA-assisted psychotherapy trials, the three preparatory sessions (90 mins each) are critically important for the participant and therapists to get to know each other and establish a trusting relationship. The therapists gain an understanding of the personal history and day-to-day struggles that the person is facing. Creating a safe and supportive environment is essential for a steady foundation for the upcoming MDMA sessions. Participants also learn practical techniques to help manage anxiety and to cope with stressful situations.   

After preparing, participants have 2 to 3 MDMA sessions spaced a month apart. During these 8-hour psychotherapy sessions, participants can take a close inspection of traumatic memories while remaining emotionally engaged. Severe anxiety and dissociation are symptoms of PTSD that inhibit progress with talk therapy. A study participant at the Charleston, SC site described how different MDMA-assisted psychotherapy was compared to other therapies by saying,

“I had a lot of defenses going up into the therapies that I had previous to the MDMA, and it made accomplishing any substantial breakthroughs in what I was going through pretty impossible. So with the MDMA, it broke this hard, outer shell that was up that kept me from being able to connect with the therapies I was going through [5].”

MDMA can reduce fear and resistance to explore painful memories while allowing the person to more fully experience difficult feelings, such a pain, shame, and grief, without becoming overwhelmed or numbed out. The environment and interactions with the therapists support the therapeutic process with MDMA, as described by a person with PTSD who underwent treatment:

“I think that the MDMA gave me the ability to feel as though I was capable and safe of tackling the issues. Whereas before I feared those thoughts and I tried to avoid them at all times, and avoid things that reminded me of those thoughts, I think it allowed me to feel safe in my space. Of being able to fight it. I felt like I had the ability and tools, whereas before I was unarmed, unarmored, and had no support. And this type of environment, with (the therapists), the catalyst drug, and everything else, it felt as though I had backup. Now it was safe and I had my tools and weapons to be able to tackle the obstacles that I never had before [5].”

The combination of the drug plus therapy can facilitate a deep a healing and release of entangled emotions that may have been otherwise inaccessible. Participants describe a speeding up of a process to get to the root of where their PTSD symptoms stem.

“I just think it would have been several more years of painful maybe terrible therapy that went nowhere. I feel like this therapy really helped me get past the tears and get right to the problem and several other problems I didn’t know were related to the feeling,” said a MAPS’ trial participant [5].

It’s thought the combination of the MDMA, the therapists, and the supportive setting create optimal conditions for a person to heal their psychological wounds. The therapists offer encouragement and an empathetic presence, supporting whatever is coming up for the person without directing the therapeutic process.

Like a prism, MDMA sheds new light on a person’s past, illuminating fractured parts of the self that can be stitched back together to instill a sense of wholeness. It can be a transformative treatment that reminds a person that the present is the time and place to live, and past hardships can be reframed through a lens of compassion and empathy.  

One study participant described this as, “It was really that first MDMA session that we had, where I had that, I consider it a breakthrough, where I was able to clearly see that I had a big disconnect in compassion for myself [5].”

Novel insights and shifts of perspectives often arise, allowing for corrective experiences through the process of forgiveness, acceptance, and a sense of wellbeing. The therapists and participant continue therapeutically process during the 3 integrative sessions that follow each MDMA session.

“I’m definitely better, but I’ve got to continue on. This isn’t something that you take a pill or push a button and say, “I’m well.” (It is something I) will be working on for a long time. (But) I have definitely moved light years ahead in a short period of time [5].”

Phase 2 Outcome

The participants said as their PTSD symptoms decreased, they were more fully able to engage in life and relationships in ways that were not possible before undergoing MDMA-assisted psychotherapy. At the long-term follow-up visit 12 months after completing the treatment, more people did not meet PTSD criteria (68%) than at study exit, defined as the last time their PTSD symptoms were measured (1 to 2 months after their last MDMA session).

Brains on MDMA – possible mechanisms for therapeutic effects

Because MDMA targets several neurotransmitters (serotonin, norepinephrine, dopamine) and increases hormone levels (oxytocin, cortisol, vasopressin, prolactin), many neurobiological mechanisms likely underlie the therapeutic effects. Going beyond a biological explanation, psychological and psycho-spiritual aspects of MDMA-assisted psychotherapy are paramount for understanding the full spectrum of therapeutic effects.

In human brain imaging, MDMA decreases activity in the amygdala in response to negative emotional stimuli (angry facial expressions) [6], which may partially explain why people with PTSD can more readily revisit traumatic memories while staying emotional engaged. Another imaging study showed that MDMA causes more crosstalk between the amygdala and hippocampus – hubs for memory and emotional processing [7]. When trauma memories are recalled during MDMA sessions, additional information may be incorporated into the memory traces, allowing for them to be filed back in the brain in a way that signifies the threats of the past are no longer part of the present moment. This is referred to as memory reconsolidation and could be one way that MDMA is working during talk therapy [8].

Translation of findings from animal models to humans is not without limitations, but these studies can give us a better idea of how a drug is acting in the brain. MDMA has been widely investigated in rodents to understand the effects of “Ecstasy”. But most rodent experiments tested extremely high, repeated doses of MDMA that were not close to what humans consume. The dose and the context are interplaying factors, each significantly contributing to subjective experience.   

Now researchers are using doses closer in the range of those used in human clinical trial in experiments designed to mimic PTSD or further characterize MDMA. The goal is to understand what is happening in the brain to produce such dramatic improvements in PTSD symptoms, and to understand possible ways to optimize this treatment.

A recent publication in Nature found that MDMA makes social activity more rewarding to mice, similar to how mice respond when they are younger. The effects on social behaviors lasted for up to 2 weeks after MDMA. The experiments found this response depended on increased oxytocin release from MDMA-stimulated serotonin elevations in the nucleus accumbens, a region of the brain important for signaling reward [9]. Prosocial effects after MDMA have also been shown in octopuses, zebra fish, and rodents [10, 11]. Social behavior between unfamiliar mice also increases with successive doses of MDMA that are moderately higher than those given to humans. These findings suggest that MDMA enhances social reward learning, which could explain the observed increased therapeutic alliance between the co-therapy team and participants undergoing MDMA-assisted psychotherapy.

Other studies in rodents have posited that the reductions in PTSD symptoms are due to fear extinction and memory reconsolidation. Mice trained to associate a foot shock with an auditory tone were more quickly able to forget that the tone signified a negative stimulus when given MDMA. The effect was dependent on increased bran derived neurotrophic factor (BDNF), a signaling molecule involved with neuroplasticity, in the amygdala. This finding suggests new adaptations in the brain region that fires up in response to fear [12].

A different study in rats showed that MDMA blocked the reconsolidation of fear memories but failed to detect enhancement of fear extinction which relies on different pathways in the brain [13]. Discrepancy in findings between these two studies could be from the different species used (rats vs. mice) or from variations in experimental designs. A study in humans is currently underway at Emory University investigating MDMA and fear extinction with a startle response model.

As we learn more about how MDMA works in the brain when administered in specific contexts, other types of approaches and therapeutic modalities may find that MDMA can bolster treatment outcomes. New research trials are being planned to investigate this question, and also to see if MDMA-assisted psychotherapy could be useful for other psychiatric indications, such as eating disorders, substance use disorders, and other anxiety-related conditions.

Current affairs for MDMA research

In August 2017, the FDA granted Breakthrough Therapy designation for MDMA-assisted psychotherapy for treating PTSD after reviewing the results from the six phase 2 trials. Comparison of findings from MDMA trials to results that led to the approval of sertraline (Zoloft) and paroxetine (Paxil) for PTSD, suggest that MDMA-assisted psychotherapy could have substantial improvement and lower overall risk than existing medications used to treat PTSD. Since MDMA is given three times in a clinic, it has fewer side effects and lower risks than take home medications that are taken daily for extended periods.

MDMA-assisted psychotherapy is now the final round of testing in two phase 3 trials. These studies will enroll approximately 200-300 participants with severe PTSD at 15 study sites in the USA, Canada, and Israel. If results replicate the phase 2 trials, then MDMA could be approved for use in therapy for treating PTSD by 2021.

 

Source: PsychedelicSupport.


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Cannabis Kills All Types of Cancer Cells That Science Has Tested so Far
May 10, 2019

Cannabis Kills All Types of Cancer Cells That Science Has Tested so Far


Standard cancer treatment must be adapted to the type and location of tumor, whereas cannabis is an equal opportunity killer. Cannabis kills all types of cancer cells.

Curing cancer is the holy grail of medical research and it’s the most-coveted breakthrough of our time. If we could discover a way to prevent malignant cells from overrunning the human body, not only would we save millions of lives, we would end years of suffering. And, we could finally feel superior to sharks which are rumored to be cancer free (It turns out, they actually can be afflicted). Is cannabis the way? Studies, so far, show that cannabis kills all types of cancer cells.

cannabis, CBD, sharks, cancer, THC, cannabinoids, endocannabinoid system, chemotherapy, research, USA, legalization

Image credit: anas sodki

One Treatment Doesn’t Fit All

While chemotherapy and radiation have certainly helped humanity’s battle against cancer, research into the recently discovered (1990s) endocannabinoid system keeps providing new information about how tumors form, spread and turn deadly.

But cancer isn’t just one thing. It’s an umbrella term for a collection of related illnesses. What unites these is the method of mayhem: cancer divides and spreads like ants at a picnic. And because it’s not just one kind of ant, we’ve developed slightly different ways to deal with each species.


cannabis, cancer, cannabinoids, CBD, THC, endocannabinoid system, chemotherapy, research, medical cannabis, legalization, USA

Image credit: Juan Gaertner

Partially, that’s because when cancer infects the brain, we can’t necessarily handle it the way we would handle cancer in the foot. Even if the same treatments would effective at stopping the cancer, the collateral damage to brain cells is just too risky.

But when cannabis treats cancer, it doesn’t cause the kind of negative side effects that chemotherapy, for instance, does. Although human trials and solid scientific research are still a ways off, early studies indicated that cannabis might be the one truly universal way to kill cancer cells.

cannabis, angionesis, cancer, cannabinoids, endocannabinoid system, CBD, THC, cancer treatment, research, legalization, medical cannabis, USA

Image credit: ellepigrafica

Cannabis Stops Blood Vessel Formation For All Types of Tumors

One of the key ways that cannabis combats cancer is through anti-angiogenic effects. That sounds like a mouthful, but the concept is straightforward. Angiogenesis is the process by which new blood vessels form from old ones — like a potato sprouting. New blood vessels are how wounds heal, people grow, and new and better pathways form for circulation. It’s a vital and healthy part of the body’s daily regimen. But it’s also how tumors transition from benign growths to malignant cancers.

Cancer creates cells that don’t have the ability to divide in a controlled fashion, leading to out-of-control growth. But what fuels that growth? For tumors to get larger and spread, they need a supply of essential nutrients and oxygen, which they get from the bloodstream. So when a cancer begins to grow, it has to do so at the same rate as the blood vessels which nourish it. Without new vessels, the tumor couldn’t expand. Thus one of the best ways to combat cancer growth is by limiting the ability of the body to generate new blood vessels. That’s anti-angiogenesis.

cannabis, blood vessels, CBD, THC, cannabinoids, endocannabinoid system, research, legalization, USA, angiogenesis, chemotherapy, medical cannabis

Image credit: Crevis

And cannabis happens to be particularly effective at that. New blood vessel growth is regulated in part by the body’s endocannabinoid system, so when cannabinoids enter the body and react with that system, it interferes with cancer’s ability to force new blood vessel growth. By taking up room in the protein receptors, cannabinoids prevent cancer from commandeering and directing the body’s new growth functionality — at least to a point. In this study, tumor growth was significantly slowed, although not completely stopped. And, amazingly, this happens to work against cancer cells, but not against normal new blood vessel growth.

Cannabis Stops Metastasis for All Tumor Types

As tumors grow, some cancer cells acquire the ability to escape the primary mass and proceed to invade surrounding tissues or migrate to distant sites, where they found new colonies. This is known as metastasis. It’s what responsible for most human deaths from cancer. These rogue cells invade healthy tissue, grow new tumors, and limit the body’s organs form fulfilling their life-preserving duties. So the best way to prolong cancer patients’ lives are to ensure that these cells don’t escape tumor masses and found new cancer sites.

cannabis, cancer, CBD, THC, cannabinoids, endocannabinoid system, research, chemotherapy, legalization, USA, glioma

Image credit: Carl Dupont

That’s where CBD comes in. Cannabinoids play a key role in cell migration, invasion and metastasis. Specifically, CBD has proven anti-proliferative effects on glioma cancer cells by inducing something called apoptosis. From the Greek for “falling off,” apoptosis can be best be understood as a cell’s self-destruct sequence. It’s how the body rids itself of bad or non-performing cells. Cancer can fool the body into thinking that tumorous cells aren’t bad and shouldn’t undergo apoptosis, but CBD has been found to mess with that ability and allow the body to kill the cancerous cells.

CBD Can Lead to Tumor Shrinkage

Studies have also shown that CBD aids tumor regression. One found that cancer in mice was reduced by 70 percent in 18 days after they were treated with CBD. Again, this was glioma (a particularly nasty type of cancer that starts in the brain and spine), but the researchers suggest that the anti-tumor activity associated with CBD could be carried over into other cancers.

cannabis, cancer, cancer treatment, research, CBD, THC, cannabinoids, endocannabinoid system, cancer cells, legalization, medical cannabis

Image credit: Photographee.eu

The way scientific research works means that cancer treatments will be approached whack-a-mole style — one at a time. For example, cannabis has to be proven to treat lung cancer and brain cancer individually. So the only way we’ll know if cancer is the panacea against cancer that we all hope it to be, is to find that out one disease at a time.

Source: RXLeaf.


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Why 'Microdosing' LSD & Other Hallucinogens May Be The Saving Grace For People With Severe Depression & Anxiety
April 30, 2019

Why 'Microdosing' LSD & Other Hallucinogens May Be The Saving Grace For People With Severe Depression & Anxiety

 

What if your brain on acid, 'shrooms and Molly isn't such a bad thing after all?

Many might consider lysergic acid diethylamide (LSD), also known as "acid", taboo (and possibly even passé), yet the currently illegal and unregulated drug is rapidly gaining popularity, as well as media scrutiny and attention within the medical community.

The widespread illegality of these substances means little scientific data exists regarding their potential short and long-term positive or negative effects on either mental of physical health, but this time around, the trendy way of dropping acid and other hallucinogenics such as psilocybin "magic" mushrooms and 3,4-Methyl​enedioxy​methamphetamine (MDMA, aka "Molly" or "ecstasy") involves a practice called "microdosing."

rong>As one report in Scientific American explains:

"Microdosing involves taking roughly one-tenth the 'trip' dose of a psychedelic drug, an amount too little to trigger hallucinations but enough, its proponents say, to sharpen the mind. Psilocybin microdosers (including hundreds on Reddit) report that the mushrooms can increase creativity, calm anxiety, decrease the need for caffeine, and reduce depression."

 

 

Georgia (not her real name) was nine years old when her father was murdered.

Even at that young age, she says, “I hit a really hard trauma wall and I never really came out of it.”

She was consumed with anger, went four months without speaking, and had a severe depressive episode at 13.

The now 29-year-old, who works at a Washington, D.C. nonprofit, was diagnosed with persistent depressive disorder (dysthymia) — defined as a "continuous, long-term (chronic) form of depression" — four years ago.

At the time, she was prescribed the antidepressant Wellbutrin, a norepinephrine-dopamine reuptake inhibitor (NDRI), which was effective in treating her depression. But after she left her job and lost her health insurance, she could no longer afford prescription medication.

 

Read the full article here: YOURTANGO.COM

 

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Psychedelic therapy: The patients paying $2k to get high with their doctor
April 29, 2019

Psychedelic therapy: The patients paying $2k to get high with their doctor

 

Jesse Noakes had been battling his mental health for years when he stumbled across Carlo, a new breed of doctor who promised to change everything.

It’s about 3pm on a Tuesday and I’m in an apartment in Sydney with harbour views.

I can’t see much from where I am, though, lying on a couch with an eye mask covering my eyes and Handel’s Messiah playing through headphones.

A couple of hours earlier I’d been a bit nervous — around the time I swallowed a capsule of MDMA and two grams of powdered magic mushrooms. But I know the apartment’s owner, my therapist, is sitting on the floor across the room, with his dog curled up next to him, and it reassures me, so I lie back and allow the choral voices to swell until they fill my whole awareness, and I go somewhere else.

It wasn’t the first time I’d come to Sydney to spend an afternoon tripping. The first time, I drove across the Nullarbor from Perth to get there in an old ’93 Holden Barina — these days it is a short flight down from Byron. Not as far as Europe or New York, which is where my journey began.

In the middle of 2016 I went to a conference in Amsterdam dedicated to a field of research I’d only just heard about: psychedelic therapy. I told everyone I was attending as a journalist; in reality, I was on the hunt for a therapist of my own.

I flew halfway round the world in uncut desperation. After a decade of therapy and medications, I was as depressed as ever. One airless afternoon in January 2016, I rolled out of bed and pulled up an article I’d seen months earlier about American hospitals giving some patients magic mushrooms for depression and anxiety in clinical studies. Three-quarters showed significant improvements in their mental health.

UNEXPECTED RESEARCH

That wasn’t all. Six placebo-controlled trials using MDMA for people with post-traumatic stress disorder (PTSD) from war and sexual assault found 68 per cent were in complete remission a year after three all-day sessions. After a couple of regular therapy sessions to prepare them, participants would come to a comfortable office and lie down on a sofa with an eye mask and headphones on and take a trip while a pair of therapists sat by their side.

One participant, Ed Thompson, a firefighter from South Carolina, told me his life before the trial “was kind of like a waking nightmare where all of these memories were randomly hitting me”. “There was a part of my brain that was stuck in those moments,” he said. “It was basically a constant panic attack that I lived in, an almost unending panic attack.”

When he enrolled in the trial, he rated 30 points higher than the most severe threshold for PTSD — and after three MDMA sessions, he no longer had PTSD.

“I’m happy again, I’m not numb, I love life, I love my family. I’m able to absorb the good moments and feel the bad ones. I couldn’t be better,” he said.

It was like stepping through a doorway into a secret room. Until now, I’d always thought psychedelics, which are illegal Schedule 9 substances in Australia, like LSD and mushrooms sent you crazy. Suddenly, it sounded like, used responsibly with appropriate therapeutic support, they could be effective ways of regaining sanity.

Patients say they feel a sense of peace like never before. Picture: Supplied

Patients say they feel a sense of peace like never before. Picture: SuppliedSource:istock

HEADING UNDERGROUND

For several months, I investigated here in Australia. I quickly realised legal clinical trials were off limits. A small organisation called PRISM had been advocating psychedelic research here for years but appeared to have little support for their proposed studies.

At the Amsterdam conference, in between talks like “Brain imaging and depression research with psychedelics” and “MDMA for trauma integration”, I met a therapist I’ll call Carlo (all the names of underground therapists and their clients have been changed in this piece).

I explained how trapped I felt — dead to the world, unsure why it felt so unreal and distant all the time. “Come to New York,” he said. “I’ve got just the thing.”

Underground psychedelic therapy fills the gap left by limited trial spaces and a regular therapy paradigm that doesn’t do the job for many. A Vox article recently called it a “parallel mental health service” in the United States. “This stuff is exploding,” a therapist in California told me last year.

Dr Rick Doblin is the founder of the non-profit Multindisciplinary Association for Psychedelic Studies (MAPS) that has organised most of the research into MDMA therapy in the US. Although he’s spent decades establishing legal studies, he understands why so many people are turning to illegal alternatives.

“We’ve got people in regular therapy who are desperate and stuck. The laws make it impossible for them to access the help they need, so going to underground therapists is perfectly appropriate. However, I’m sad it’s the only option for some people — it means we’ve got to move quickly to legitimise it,” he said.

Ed Thompson is even more effusive. “People like the underground therapist you’re discussing have got to be some of the greatest heroes of our time because of the legal risks, because of the risks to their careers and knowing that it’s gotta be done regardless of stupid bureaucratic red tape.”

Professor Steve Kisley, Chair of the Psychiatrists Group of the Australian Medical Association, is more cautious.

“There are some promising findings, but they are insufficient at this time to advocate general clinical use. While use remains unregulated, there are dangers in terms of side-effects and toxicity from incorrect dosing and impurities in illegal supplies, which could outweigh any clinical benefit. The same would apply to ‘underground therapists’.”

BREAKTHROUGH THERAPY

The clinical research so far has been so promising the US medicines regulator has declared both MDMA and mushrooms “breakthrough therapies”, giving them additional resources to bring to market. But it’ll still be a couple of years before the final phase of trials are completed and psychedelic drugs become a legal therapy option for the first time since the 1960s (when substantial research was conducted, and everyone from Cary Grant to the founder of Alcoholics Anonymous discussed the benefits of therapy with LSD).

The Beatles famously experimented with psychedelic drugs. Picture: John Downing/Getty Images

The Beatles famously experimented with psychedelic drugs. Picture: John Downing/Getty ImagesSource:Supplied

In the meantime, researchers and therapists I’ve spoken with across America reckon there are hundreds of facilitators guiding patients through psychedelic experiences. Training varies, and so do prices. I spoke to two therapists in California, both of whom have graduate degrees in psychology — one charges on a sliding scale that starts at $US500 ($A700), the other charges $US2000 ($A2800) per session.

Carlo, my guy in New York, charges up to $1500 for an overnight stay.

TAKING DRUGS TO KICK THE HABIT

Why would people want to fork over a fortnight’s pay to take drugs with their therapist? I asked another of Carlo’s clients, Alba, a New Yorker in his late 20s who has suffered from chronic social anxiety since his teens. Both his parents had abused him growing up — he remembers having his head bashed against heavy oak bed frames when he was just a toddler.

Before he had his first session with Carlo late last year, he was drinking a bottle of vodka every evening to control the crippling paranoia and discomfort he felt at work. Several years ago, after he attempted suicide twice within a week, he vowed he wouldn’t try again until he’d fully exhausted his options. Through a subreddit thread he contacted people who put him in touch with therapists, which led finally to Carlo’s loft.

At one point in his first session with MDMA, he suddenly felt a new sense of safety and love. He asked Carlo for a hug, which he’d never done with his own father. “I don’t like people touching me. I just get really, really tense. But with him, for some reason my guard was down.”

Brain imaging has shown MDMA profoundly deactivates the amygdala, the part of the brain that regulates our fear and anxiety responses and promotes production of oxytocin, known as the “trust hormone”.

After that first session, Alba quit drinking. He’s been sober for five months now, bar a brief relapse after Christmas. He lives in a much larger, lighter apartment, he’s turning up to work on rough days when previously he’d have stayed in bed with a bottle of vodka, and he feels optimistic about his future. “It allows me to look at all those horrible situations in a completely different light.”

Patients report the treatment as being like nothing they’ve ever experienced. Picture: iStock

Patients report the treatment as being like nothing they’ve ever experienced. Picture: iStockSource:Supplied

Dr Ben Sessa is a British psychiatrist leading a clinical trial in the UK using MDMA to treat alcoholism. All but one of the patients he’s treated so far have stayed sober after their therapy with the drug, Sessa reports. “They talk about ‘I can see the light, I can see the folly of alcohol, and I have no interest in returning to it’,” he said.

Sessa is cautious about therapists recreating his trial underground. “I have no doubt there are some excellent underground therapists who have really good results, but there are also plenty of scare stories of very poor ones. What the underground therapists tend to miss is the importance of the non-drug sessions.”

Post-drug therapy sessions, known as integration, is a crucial tenet of the psychedelic therapy movement. Some of the drug experiences people have are so far outside the realms of their usual experience they need help to make sense of them, says Dr Rick Doblin.

“The idea of a one-dose miracle cure is really dangerous. It requires a lot of work on an ongoing basis,” he said.

NOT A MAGIC BULLET

Of course, nothing works for everyone, all the time. The first two sessions I had using MDMA, with a European doctor I also met in Amsterdam, were underwhelming, and left me feeling disappointed and desperate.

I had some visions, but probably nothing more than you’d expect when you spend all day lying in a dark room with your eyes closed. It was nothing like the breakthrough I’d been hoping for, and after the first session I messaged a friend: “The drugs don’t work.”

I felt more like it was me that didn’t work.

For others, rather than finding nothing, their sessions revealed too much. A friend of mine in California found immediate relief from PTSD during his first MDMA session, but then suffered weeks of black depression afterwards.

Since then, his road has been rocky — while he’s done further sessions with other psychedelics and therapists, he still fights with panic and depression, and uses exercise, lifestyle choices and prescription medication to try to keep the wolf from the door.

Psilocybe cubensis is a species of psychedelic mushroom. Picture: Supplied

Psilocybe cubensis is a species of psychedelic mushroom. Picture: SuppliedSource:Supplied

THE SCENE DOWN UNDER

Maria offers psychedelic therapy from what would normally be the dining room of her ordinary brick bungalow in the forest outside a major Australian city.

A rooster crows outside the window as we chat at her kitchen counter over green tea. She closes the dishwasher as I sit down.

Maria runs both group and individual sessions, with a range of “medicines” — MDMA, psilocybin, ayahuasca. She charges $270 for a group session and $550 for one-on-one — not bad for an intensive seven-hour treatment that carries serious legal risk.

“I try not to think about it,” she tells me when I ask about it.

I’ve spoken to two therapists overseas who’ve been prosecuted for treating patients with psychedelics. Both received suspended sentences, and both continue to work with clients — one now runs a legal psilocybin retreat in Jamaica.

Both Carlo and Maria operate by word of mouth, and besides knowing someone who’s already been, it’s not clear how you’d find one of them.

“I don’t really know,” Maria says. “At the moment it’s just referrals from people that I’ve treated. There’s definitely more interest in psychedelics in the past few years.”

Maria has a client list of more than 600 people — Carlo says he receives about three new inquiries a week, and when I spoke to him recently he’d just flown back to New York after treating four clients in LA.

A member of the team behind the recently announced trial of psilocybin for anxiety and depression in Melbourne said he was aware of perhaps a dozen underground therapists in this country. “But there are probably more, given that most try to keep a very low profile. Some of the therapists keep in touch and share information, but even that’s risky in the current legal climate.”

WHAT NEXT?

Dr Doblin founded MAPS in 1986 to legalise MDMA and has spent three decades of tireless advocacy to get to a point where it’s suddenly foreseeable. He says his quixotic mission is motivated by gratitude.

“I will never repay all the benefits I’ve got from psychedelics. All of this work has still not even paid back for the good I’ve received from these drugs,” he said.

I know how he feels. In Sydney, as the choir reached its rapturous peak, I saw the world as a big, blue blanket, each of us a stick poking into it, like a million tiny tent poles.

Movement from any one stick shifted the tautness and balance of the blanket, weighing down or buoying up every other stick in a contiguous wave. Seeing is believing, as they say, and this was more like a real-life VR experience of a different world. I felt a rapturous sense of connection and possibility.

Jesse Noakes is one of a growing number of people seeking relief in psychedelic therapy. Picture: Peta Roebuck

Jesse Noakes is one of a growing number of people seeking relief in psychedelic therapy. Picture: Peta RoebuckSource:Supplied

It didn’t go away when the drug wore off. For months afterwards, I felt more confident and socially connected than ever before. The world was a lot more fun. I spoke each week to my therapist on the phone. We spent much of those conversations discussing my work, trying to care for traumatised teenagers who had been removed from their families. I found them wildly intense and incredibly energising. “It’s the best therapy I’ve ever done,” I told him, “with the possible exception of coming to Sydney to take mushrooms and MDMA with you.”

Psychedelic therapy is currently illegal in Australia and unregulated use carries significant risks that may outweigh any benefits.

Source: News.com.au

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The Push To Legalise MDMA In Australia
April 28, 2019

The Push To Legalise MDMA In Australia


Ahead of the federal election this May, one party is calling for party drug MDMA to be regulated and legalised.

According to the Greens, legalising the substance would lead to a decrease in festival deaths, weeding out deadly impurities and encouraging more responsible consumption.

With a background in criminology, Greens candidate for Warringah Kristyn Glanville believes the Government's criminalisation model has been useless in stopping young people from dying and discouraging people from taking drugs.

"The Greens support regulating the supply of MDMA, as this would mean that we can ensure the contents are consistent. It would also mean that people are given accurate health information at the point of sale," Glanville told 10 daily.

Kristyn Glanville, Greens candidate for Warringah. Image: Facebook

"MDMA use should be primarily treated as a health issue. In countries like Portugal where a decriminalisation model has been adopted, people are less likely to overdose and more likely to seek help for addiction," she said.

MDMA overdoses are responsible for fewer deaths than horse riding each year. Fatalities from MDMA are normally a result of organ failure from overheating, or the effects of drinking too much water.

However, medical experts like Dr David Penington from the University of Melbourne say pure MDMA has an extremely low addiction potential and is less dangerous than alcohol, tobacco or cannabis.

It even has legitimate health benefits in some cases, he claimed.

"MDMA can be useful in managing some psychiatric problems including Post Traumatic Stress Disorder," Dr Penington told 10 daily.

"It's a drug that can be of real value but the danger is when people take it when overheated, dehydrated and consume an unwise number of tablets," he said.

MDMA's effects include increased empathy, euphoria and enhanced sensory perception. But withdrawal can be tough on drug users, with mild depression and irritability lingering days after consuming ecstasy.

According to Dr Penington, Australia is leading the world in ecstasy use and making MDMA a prescription that is overseen by medical professionals would lead to increased education on how to safely consume the drug.

Image: Getty Images.

Greens MP Cate Faehrmann , the party spokesperson for drug law reform, said young people are naturally curious 'with many turning a blind eye to the government's "just say no" message' and a different approach is needed.

"As politicians we can keep our heads in the sand or regulate the supply of MDMA, taking control of this drug out of the hands of organised crime and save lives in the process," she said.

When it comes to pill testing, Glanville believes the Government should "acknowledge the elephant in the room" that people are taking drugs at festivals "no matter how high the penalties are or how many police dogs you send".

MDMA capsules. Credit: Positive Choices.

Glanville said she hoped for a change in mindset around drugs.

"Drug use is often stigmatised or seen as a moral issue where judgment is passed about people who use drugs. I think current politicians don't want to be seen as encouraging risky or 'immoral' behaviour," she said.


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April 26, 2019

Professor in western Japan allegedly made students produce MDMA


 

MATSUYAMA(Kyodo) -- A pharmaceutical science professor at a university in western Japan was referred to prosecutors Tuesday for allegedly making his students produce synthetic drug MDMA without a permit, investigative sources said.

Tatsunori Iwamura, 61, of Matsuyama University in Ehime Prefecture, admitted to the allegation, telling investigators that he did it in order to help his students' "learning."

According to the sources, Iwamura allegedly instructed students to produce MDMA in 2013, despite him not being licensed to produce the drug for academic purposes.

The regional drug enforcement authority sent to prosecutors investigative papers on Iwamura as well as on several former students who were involved in the production of MDMA under his instructions.

The MDMA they produced has not been found, but a trace of another drug was discovered in his laboratory, according to the sources.

MDMA is often a constituent ingredient in the recreational drug commonly known as ecstasy.

"We apologize from the bottom of our heart for causing major trouble for students and their parents," said Tatsuya Mizogami, president of the university.

He also said the university will consider taking measures to prevent similar incidents from happening again and that it will take disciplinary action on Iwamura in accordance with the outcome of the investigation/

The investigation started following a tip-off from an outsider. The drug enforcement officers at the health ministry's regional bureau searched Iwamura's home and lab, while also questioning the professor since January.

Based on the Japanese narcotics control law, which Iwamura allegedly violated, a researcher must obtain a license issued by the prefectural government hosting the research lab to make narcotics for academic research.

According to the sources, Iwamura had obtained a license from a prefecture other than Ehime, but it had expired.

Iwamura, as professor of the College of Pharmaceutical Sciences at Matsuyama University, has been conducting research on what are called dangerous drugs in Japan, defined as those containing chemical agents that can cause hallucinations or have a stimulant effect, according to the sources.

 

Source: MAINICHI.


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Decades ago, ecstasy — yes, MDMA — was used in marriage counseling
March 24, 2019

Decades ago, ecstasy — yes, MDMA — was used in marriage counseling

For the first decade after it was synthesized, MDMA was used in individual and couples therapy.
Many therapists spoke against the criminalization of MDMA in 1985 due to the drug's therapeutic potential.
A revival has occurred in recent years, with the government allowing clinical trials to move forward.

 

Before the second "M" was affixed to "MDA," researchers spent decades searching for a utility for the mescaline derivative. Patented as "methylsafrylamin" in 1914 by Merck, the drug was shelved because no one could quite figure out what to do with it — similar to the incredible story of LSD.

That was until California pharmacologist Gordon A. Alles realized that MDA was rather interesting, indeed. He partnered with Chilean psychiatrist Claudio Naranjo to test out this "psychotherapeutic" substance. Naranjo's partner, Alexander Shulgin, synthesized the more commonly known MDMA, which proved to be less hallucinogenic and less toxic than its original formation.

An early enthusiast was psychotherapist Leo Zeff, who began using psychedelics such as LSD in his practice in 1961. A few years later he discovered MDA through an associate of Shulgin. In 1977, Shulgin introduced Zeff to his new synthesis, which the therapist immediately took to. He trained more than 150 therapists in its usage over the next 12 years, administering it to over 4,000 clients.

This changed in 1985 when the U.S. government labelled MDMA a Schedule 1 drug, claiming it has no therapeutic utility. Many therapists offered testimony to the contrary, to no avail. Zeff, along with many others, went underground. This wasn't the government's first foray into an MDA derivative: in the 1950s the U.S. Army declared it to have no military use since the only feeling it seemed to invoke was compassion. In a country that spends more on defense than any other nation in history, this simply would not do.

As with many other victims of the "war on drugs," both Nixon's and Reagan's, MDMA got itself in trouble by becoming popular outside of therapy, namely on dance floors. Teenagers enjoying themselves dancing to club music was apparently a social burden. Granted, as with virtually every substance, MDMA has a toxicity level that must be recognized; not every club night ended happily. To declare it useless, however, points more to the mindset of the administration than the therapist's couch.

Rick Doblin On Using MDMA In Couples Therapy

 

Especially when that couch is a bed. While MDMA is now being shown to help alleviate PTSD, and many therapists used it in individual counseling in the 1970s and '80s, couples received immense benefits from ingesting this "love drug" in its early days. Rick Ingrasci, who used LSD in therapy until it was banned, turned to MDMA next. Between 1980–85, he treated 100 patients in over 150 sessions; a third of his sessions were with couples.

To be clear, MDMA is not a "sexual" drug. When Ann Shulgin, Alexander's therapist wife, administered it to patients, she made them consent to the "four agreements," one of which was "no sexual activity." Confusing boundaries could easily be breached when one is in such an open, transparent state.

That does not mean there is no sensual element. Sensuality in this context requires a redefinition, such as the way your favorite food enlivens your senses and a song embeds itself deeply into your consciousness. A strong bonding element is possible with MDMA, which applies to one's mindset as easily as relationship challenges faced by couples.

Professionals have always realized this. While Friederike Meckel Fisher was imprisoned for using psychedelics, including MDMA and LSD, in her therapy practice after a spurned client retaliated, she now advocates for their usage in couples therapy. MDMA alleviates fear, she says, which allows individuals to access parts of their minds they might normally suppress. When you feel safe being vulnerable with your partner the potential for healing and growth becomes possible.

Source: Bigthink.

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Highly Accredited Doctor States “MDMA Not Too Dangerous”
March 21, 2019

Highly Accredited Doctor States “MDMA Not Too Dangerous”

 

The debate over whether or not MDMA is dangerous has been going on for decades. It has gone as far as whether it should be legalized, or if there should be pill testing centers at festivals. It has been looked down upon by society due to the numerous deaths the drug has caused. But on the other side, recent studies have shown MDMA may actually have positive medical effects. Specialist GP David Charles Thomas weighed in on the debate that is central to so many countries.

According to the doctor, the drug is “not that dangerous” when taken in “pure form.” The real danger lies in the illegal market that the drug functions in. People don’t know what they are taking and its almost impossible to tell. He said all this on a podcast called “Triggered.” The GP went into how the drug causes self-excitement but at the same time limits an individuals ability to self-regulate their temperature.

“IT CAN MAKE THEM FEEL LIKE THEY HAVE A LOT MORE ENERGY, BUT IT ALSO DECOUPLES THEIR TEMPERATURE REGULATION AND THEIR PERCEPTION TO THE EXTENT OF ANY WARNING SIGNS.”

The podcast centralized around the debate over pill testing in Australia, something not really debated here in the states. There have been many deaths at festivals over the past two years and the public wants some form of pill testing. As the debate rages on some parties have discussed the potential for passing a bill for testing. However, it would most likely need to be seen that the drug has positive medical uses. Similar to how marijuana has become legal.

At the end of the day, even if bills like this don’t pass, people should still be testing their pills at home. It is better to be safe and remember to stay hydrated.

Source: Edtumes.

 

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Israel Joins the Medical MDMA Movement
March 20, 2019

Israel Joins the Medical MDMA Movement

Apparently, medical MDMA is having a moment.

Most people probably never imagined that “medical” and “MDMA” would eventually hook up, but in the past year, the Food and Drug Administration (FDA) declared MDMA a breakthrough therapy for post-traumatic stress disorder (PTSD) and an Iowa Republican filed a state bill to legalize medical MDMA use. According to the Israeli newspaper Haaretz, the country's Health Ministry just approved the use of MDMA for several dozen patients.  

According to the paper, “MDMA will be administered to about 50 patients in the approved program who have been diagnosed with post-traumatic stress disorder in the course of psychiatric treatment… The decision to proceed with the program follows extensive investigative work by the Health Ministry, which sent a representative for training in the United States who worked on a confidential basis through the California-based Multidisciplinary Association for Psychedelic Studies (MAPS).” 

Haaretz suggested that the move could put the Israeli Health Ministry two years ahead of the global recognition of medical MDMA efficacy. This assumes the FDA will officially approve MDMA treatment in 2021 after the current Phase 3 trials are concluded.   

Israel prohibits MDMA, but the 50-person trial qualifies for a “compassionate use” exception for those who do not respond to more traditional therapies. Hundreds of PTSD patients have asked to be part of the trial, but only 50 will be chosen for the initial trials that are expected to start this summer.

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Wedded Ecstasy: The Couples Using MDMA to Fix Their Marriages
March 20, 2019

Wedded Ecstasy: The Couples Using MDMA to Fix Their Marriages

Many couples believe the drug can save relationships by opening up deeper lines of communication. Some therapists do, too. Could it be key to marital ecstasy?

About two years ago, Mike*, 41, had an affair. Like many who stray, he was relatively happy in his marriage to his second wife, but there was an intangible something missing from the relationship. “There was a lot going on in our life and we just weren’t connecting the way we had been,” Mike told Fatherly. “So I found someone outside of our marriage, specifically to do MDMA with.”

Although Mike wasn’t much of a drug user, he had experimented with MDMA a few times since college, mostly with an ex-girlfriend. For the most part, he’d found it enjoyable: “Lots of cigarettes, lots of pot, lots of touching one another, lots of warm showers.” But his wife had never done MDMA before, and Mike was fairly certain she wouldn’t want to try it. So he started rolling with another woman, which eventually led to them fooling around.

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