Posts Tagged ‘ecstasy’

mdma

By DAVE PHILIPPS

After three tours in Iraq and Afghanistan, C. J. Hardin wound up hiding from the world in a backwoods cabin in North Carolina. Divorced, alcoholic and at times suicidal, he had tried almost all the accepted treatments for post-traumatic stress disorder: psychotherapy, group therapy and nearly a dozen different medications.

“Nothing worked for me, so I put aside the idea that I could get better,” said Mr. Hardin, 37. “I just pretty much became a hermit in my cabin and never went out.”

Then, in 2013, he joined a small drug trial testing whether PTSD could be treated with MDMA, the illegal party drug better known as Ecstasy.

“It changed my life,” he said in a recent interview in the bright, airy living room of the suburban ranch house here, where he now lives while going to college and working as an airplane mechanic. “It allowed me to see my trauma without fear or hesitation and finally process things and move forward.”

Based on promising results like Mr. Hardin’s, the Food and Drug Administration gave permission Tuesday for large-scale, Phase 3 clinical trials of the drug — a final step before the possible approval of Ecstasy as a prescription drug.

If successful, the trials could turn an illicit street substance into a potent treatment for PTSD.

Through a spokeswoman, the F.D.A. declined to comment, citing regulations that prohibit disclosing information about drugs that are being developed.

“I’m cautious but hopeful,” said Dr. Charles R. Marmar, the head of psychiatry at New York University’s Langone School of Medicine, a leading PTSD researcher who was not involved in the study. “If they can keep getting good results, it will be of great use. PTSD can be very hard to treat. Our best therapies right now don’t help 30 to 40 percent of people. So we need more options.”

But he expressed concern about the potential for abuse. “It’s a feel-good drug, and we know people are prone to abuse it,” he said. “Prolonged use can lead to serious damage to the brain.”

The Multidisciplinary Association for Psychedelic Studies, a small nonprofit created in 1985 to advocate the legal medical use of MDMA, LSD, marijuana and other banned drugs, sponsored six Phase 2 studies treating a total of 130 PTSD patients with the stimulant. It will also fund the Phase 3 research, which will include at least 230 patients.

Two trials here in Charleston focused on treating combat veterans, sexual assault victims, and police and firefighters with PTSD who had not responded to traditional prescription drugs or psychotherapy. Patients had, on average, struggled with symptoms for 17 years.

After three doses of MDMA administered under a psychiatrist’s guidance, the patients reported a 56 percent decrease of severity of symptoms on average, one study found. By the end of the study, two-thirds no longer met the criteria for having PTSD. Follow-up examinations found that improvements lasted more than a year after therapy.

“We can sometimes see this kind of remarkable improvement in traditional psychotherapy, but it can take years, if it happens at all,” said Dr. Michael C. Mithoefer, the psychiatrist who conducted the trials here. “We think it works as a catalyst that speeds the natural healing process.”

The researchers are so optimistic that they have applied for so-called breakthrough therapy status with the Food and Drug Administration, which would speed the approval process. If approved, the drug could be available by 2021.

Under the researchers’ proposal for approval, the drug would be used a limited number of times in the presence of trained psychotherapists as part of a broader course of therapy. But even in those controlled circumstances, some scientists worry that approval as a therapy could encourage more illegal recreational use.

“It sends the message that this drug will help you solve your problems, when often it just creates problems,” said Andrew Parrott, a psychologist at Swansea University in Wales who has studied the brains of chronic Ecstasy users. “This is a messy drug we know can do damage.”

Allowing doctors to administer the drug to treat a disorder, he warned, could inadvertently lead to a wave of abuse similar to the current opioid crisis.

During initial studies, patients went through 12 weeks of psychotherapy, including three eight-hour sessions in which they took MDMA. During the sessions, they lay on a futon amid candles and fresh flowers, listening to soothing music.

Dr. Mithoefer and his wife, Ann Mithoefer, and often their portly terrier mix, Flynn, sat with each patient, guiding them through traumatic memories.

“The medicine allows them to look at things from a different place and reclassify them,” said Ms. Mithoefer, a psychiatric nurse. “Honestly, we don’t have to do much. Each person has an innate ability to heal. We just create the right conditions.”

Research has shown that the drug causes the brain to release a flood of hormones and neurotransmitters that evoke feelings of trust, love and well-being, while also muting fear and negative emotional memories that can be overpowering in patients with post-traumatic stress disorder. Patients say the drug gave them heightened clarity and ability to address their problems.

For years after his combat deployments, Mr. Hardin said he was sleepless and on edge. His dreams were marked with explosions and death. The Army gave him sleeping pills and antidepressants. When they didn’t work, he turned to alcohol and began withdrawing from the world.

“I just felt hopeless and in the dark,” he said. “But the MDMA sessions showed me a light I could move toward. Now I’m out of the darkness and the world is all around me.”

Since the trial, he has gone back to school and remarried.

The chemist Alexander Shulgin first realized the euphoria-inducing traits of MDMA in the 1970s, and introduced it to psychologists he knew. Under the nickname Adam, thousands of psychologists began to use it as an aid for therapy sessions. Some researchers at the time thought the drug could be helpful for anxiety disorders, including PTSD, but before formal clinical trails could start, Adam spread to dance clubs and college campuses under the name Ecstasy, and in 1985, the Drug Enforcement Administration made it a Schedule 1 drug, barring all legal use.

Since then, the number of people seeking treatment for PTSD has exploded and psychiatry has struggled to keep pace. Two drugs approved for treating the disorder worked only mildly better than placebos in trials. Current psychotherapy approaches are often slow and many patients drop out when they don’t see results. Studies have shown combat veterans are particularly hard to treat.

In interviews, study participants said MDMA therapy had not only helped them with painful memories, but also had helped them stop abusing alcohol and other drugs and put their lives back together.

On a recent evening, Edward Thompson, a former firefighter, tucked his twin 4-year-old girls into bed, turned on their night light, then joined his wife at a backyard fire.

“If it weren’t for MDMA … ” he said.

“He’d be dead,” his wife, Laura, finished.

They both nodded.

Years of responding to gory accidents left Mr. Thompson, 30, in a near constant state of panic that he had tried to numb with alcohol and prescription opiates and benzodiazepines.

By 2015, efforts at therapy had failed, and so had several family interventions. His wife had left with their children, and he was considering jumping in front of a bus.

A member of a conservative Anglican church, Mr. Thompson had never used illegal drugs. But he was struggling with addiction from his prescription drugs, so he at first rejected a suggestion by his therapist that he enter the study. “In the end, I was out of choices,” he said.

Three sessions with the drug gave him the clarity, he said, to identify his problems and begin to work through them. He does not wish to take the drug again.

“It gave me my life back, but it wasn’t a party drug,” he said. “It was a lot of work.”

http://mobile.nytimes.com/2016/11/29/us/ptsd-mdma-ecstasy.html

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2C-E was one of the hundreds of drugs synthesised by Alexander Shulgin, who was known as the ‘godfather of ecstasy’. Photograph: Scott Houston/Corbis

Police investigating a mass intoxication of a homeopathy conference in Germany with psychedelic drugs have said they still do not know nearly a week later whether it was an accident or an experiment gone wrong.

Emergency services called to the meeting in Handeloh, south of Hamburg, found a group of 29 alternative healers hallucinating, staggering around, groaning and rolling on the grass.

Police spokesman Lars Nicklesen said on Thursday that investigators believe a psychedelic drug was to blame but remain unsure of how or why it was taken. The delegates are now all out out of physical danger, he said, but there may yet be legal consequences for the healers in the course of the ongoing criminal investigation.

“We’re now questioning the delegates and awaiting the results of blood and urine tests,” he said. “We still don’t know if they took the drugs on purpose. The question is whether they want to talk about it; they have the right to remain silent.”

Nicklesen added that police suspect the group took 2C-E, known in Germany as Aquarust, a drug which heightens perceptions of colours and sounds and in higher doses triggers hallucinations, psychosis and severe cramps.

Germany’s health ministry banned the drug last year due to its highly addictive nature and unknown side effects.

The homeopaths’ meeting – billed as a “further education seminar” – was suspended shortly after it started when delegates began experiencing psychotic hallucinations, cramps, racing heartbeats and shortage of breath. One of them alerted the emergency services.

Alarmed by the sight of so many grown men and women rolling around on the floor, the first fire crews on the scene called for backup, triggering a major incident response. A total of 160 police, fire crews, and ambulance staff and a helicopter were involved in the four hour operation to treat the group.

“It was great that none of the people were in mortal danger in the end”, said fire service spokesman Matthias Köhlbrandt. “The leading emergency doctor at the scene believed they would all recover without lasting damage.”

Unsure of what they had taken, medical staff gave the homeopaths oxygen on site before transferring them to seven different nearby hospitals.

The Hamburger Abendblatt newspaper reported that in one clinic, the Asklepios in Harburg, hallucinating patients had to be strapped down to a bed to prevent them causing danger to others. “They were completely off their heads,” a spokesman for the clinic said.

Staff at the conference centre were unable to shed light on the mystery as they had all gone home at the time of the incident. “We’re absolutely shocked, we’ve only had good experiences in the past with the group,” a spokeswoman for the Tanzheimat Inzmühlen conference centre told the Hamburger Abendblatt.

The Association of German Healing Practitioners was quick to distance itself from the incident and emphasised that hallucinogenic drugs had no place in the study of homeopathy. “If I find out that one of our members took part [in what happened in Handeloh] then they will be excluded from the association,” Heinz Kropmanns, the association president, told NDR.

The drug 2C-E was one of hundreds synthesised by the American chemist Alexander Shulgin. The scientist, who died in 2014, and had become known as the godfather of ecstasy after he introduced MDMA to psychotherapists on the US west coast in the late 1970s.

http://www.theguardian.com/science/2015/sep/10/homeopathy-conference-in-germany-goes-awry-as-delegates-take-lsd-like-drug

Thanks to Kebmodee for bringing this to the It’s Interesting community.

Psychedelics were highly popular hallucinogenic substances used for recreational purposes back in the 1950s and 1960s. They were also widely used for medical research looking into their beneficial impact on several psychiatric disorders, including anxiety and depression. In 1967, however, they were classified as a Class A, Schedule I substance and considered to be among the most dangerous drugs with no recognized clinical importance. The use of psychedelics has since been prohibited.

Psychiatrist and honorary lecturer at the Institute of Psychiatry, Psychology and Neuroscience, at Psychiatrist and honorary lecturer at the Institute of Psychiatry, Psychology and Neuroscience, at King’s College London, James Rucker, MRCPsych, is proposing to reclassify and improve access to psychedelics in order to conduct more research on their therapeutic benefits. He believes in the potential of psychedelics so much that late last month he took to the pages of the prestigious journal the BMJ to make his case. He wrote that psychedelics should instead be considered Schedule II substances which would allow a “comprehensive, evidence based assessment of their therapeutic potential.”

“The Western world is facing an epidemic of mental health problems with few novel therapeutic prospects on the horizon,” Rucker told Psychiatry Advisor, justifying why studying psychedelics for treating psychiatric illnesses is so important.

Rucker recognizes that the illicit substance may be harmful to some people, especially when used in a recreational and uncontrolled context. He cited anecdotal reports of the substance’s disabling symptoms, such as long-term emotionally charged flashbacks. However, he also believes that psychedelic drugs can have positive outcomes in other respects.

“The problem at the moment,” he argued, “is that we don’t know who would benefit and who wouldn’t. The law does a good job of preventing us from finding out.”

From a biological perspective, psychedelics act as an agonist, a substance that combines with a receptor and initiates a physiological response to a subtype of serotonin known as 5HT2a. According to Rucker, this process influences the balance between inhibitory and excitatory neurotransmitters.

“The psychedelics may invoke a temporary state of neural plasticity within the brain, as a result of which the person may experience changes in sensory perception, thought processing and self-awareness,” Rucker speculated. He added that psychedelic drugs can act as a catalyst that stirs up the mind to elicit insights into unwanted cycles of feelings, thoughts and behaviors.

“These cycles can then be faced, expressed, explored, interpreted, accepted and finally integrated back into the person’s psyche with the therapist’s help,” he explained. Reclassifying psychedelics could mean that the mechanism by which these substances can help with anxiety, depression and psychiatric symptoms could be studied and understood better.

Several experts in the field of drug misuse have disagreed strongly with Rucker’s proposals in this area, and are quick to refute his findings and recommendations. Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA), emphasized the fact that psychedelics can distort a person’s perception of time, motion, colors, sounds and self. “These drugs can disrupt a person’s ability to think and communicate rationally, or even to recognize reality, sometimes resulting in bizarre or dangerous behavior,” she wrote on a NIDA webpage dealing with hallucinogens and dissociative drugs.

“Hallucinogenic drugs are associated with psychotic-like episodes that can occur long after a person has taken the drug,” she added. Volkow also says that, despite being classified as a Schedule I substance, the development of new hallucinogens for recreational purposes remains of particular concern.

Rucker has several suggestions to help mediate the therapeutic action of the drug during medical trials, and thereby sets out to rebut the concerns of experts such as Volkow. When a person is administered a hallucinogen, they experience a changed mental state. During that changed state, Rucker points out, it is possible to control what he describes as a “context,” and thereby make use of the drug more safe.

According to Rucker, the term “context” is divided into the “set” and the “setting” of the drug experience. “By ‘set,’ I mean the mindset of the individual and by ‘setting’ I mean the environment surrounding the individual,” he explained.

To prepare the mindset of the person, Rucker said that a high level of trust between patient and therapist is essential. “A good therapeutic relationship should be established beforehand, and the patient should be prepared for the nature of the psychedelic experience,” he suggested. The ‘setting’ of the drug experience should also be kept closely controlled — safe, comfortable and low in stress.

It is also necessary to screen participants who undergo the drug experience in order to minimize the risk of adverse effects. Rucker suggested screening patients with an established history of severe mental illness, as well as those at high risk of such problems developing. It is also important to screen the medical and drug history of participants.

“The action of psychedelics is changed by many antidepressant and antipsychotic drugs and some medications that are available over the counter, so a full medical assessment prior to their use is essential,” he said.

In order to avoid the danger of addiction, psychedelics should be given at most on a weekly basis. Indeed, for many patients, very few treatments should be required. “The patient may need only one or two sessions to experience lasting benefits, so the course should always be tailored to the individual,” Rucker advised.

If there are any adverse effects during the psychedelic experience, a pharmacological antagonist or antidote to the drug can be administered to immediately terminate the experience. “This underlines the importance of medical supervision being available at all times,” Rucker noted.

Psychedelics are heavily influenced by the environment surrounding the drug experience. Rucker is proposing they be administered under a controlled setting and with a trusted therapist’s supervision. Together with a reclassification of the drug, medical research could generate a better understanding and application of the benefits of psychedelics to mental health.

1.Rucker JJH. Psychedelic drugs should be legally reclassified so that researchers can investigate their therapeutic potential. BMJ. 2015; 350:h2902.

http://www.bmj.com/content/350/bmj.h2902/related

Possession of ecstasy and other drugs is currently legal in Ireland, but only for a day, after a court ruling on Tuesday morning.

A written judgment released by the Republic’s court of appeal said part of the Misuse of Drugs Act 1977, which allows certain substances to be controlled, is unconstitutional, meaning all government orders banning substances such as ecstasy and magic mushrooms are void – and it is not an offence to possess them.

Specifically, the court found that the act was being added to via ministerial order and without consulting the Oireachtas (both houses of the Irish parliament) and deemed this unconstitutional.

The appeal court’s ruling came in favor of a man who was prosecuted for possession of methylethcathinone, which was among a number of substances put on the controlled drugs list in 2010.

Stanislav Bederev denied the charge of having the substance for supply in 2012, and then brought a high court challenge in Dublin seeking to stop his trial, claiming that additions to the 1977 act were unconstitutional.

Bederev’s legal team argued it was not lawful to put the substance on the controlled drug list because there are no principles and policies guiding the introduction of such rules – and specifically no consultation with the Irish parliament.

The Irish government now has to force through emergency legislation in its parliament on Tuesday evening in response to the ruling.

The emergency law won’t come into place until the Republic’s second chamber, the Seanad, endorses the legislation. Following that the country’s president, Michael D Higgins, will have to gave his approval.

http://www.theguardian.com/world/2015/mar/10/irish-es-are-smiling-ecstasy-drugs-temporarily-legal-in-ireland