Sunday, April 30, 2017

Psychedelic compound in ecstasy moves closer to approval to treat PTSD

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A promising treatment that uses MDMA could help people suffering with post-traumatic stress disorder.

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Psychedelic drugs could soon help people, including soldiers, who suffer from post-traumatic stress disorder with the pain of recalling traumatic memories.
Psychologists have occasionally given people psychedelic drugs such as LSD or magic mushrooms to induce altered states, in an attempt to treat mental illness. Today, many of those drugs are illegal, but if clinical trials testing their efficacy yield positive results, a handful could become prescription medicines in the next decade. The furthest along in this process is MDMA — a drug sold illegally as ecstasy or Molly — which is showing promise in the treatment of post-traumatic stress disorder (PTSD).
Last week, at the Psychedelic Science 2017 conference in Oakland, California, researchers presented unpublished results from phase II trials involving a total of 107 people diagnosed with PTSD. The trial treatment involved a combination of psychotherapy and MDMA (3,4-methylenedioxymethamphetamine). The US Food and Drug Administration (FDA) reviewed these data in November, which were not released to the public at the time. The agency recommended that the researchers move forward with phase III trials, the final stage before potential approval of the drug.
At the conference, researchers affiliated with the non-profit organization that is sponsoring the trials, the Multidisciplinary Association for Psychedelic Studies (MAPS) in Santa Cruz, California, presented some of their latest resutls. They used a cinically validated scale that assesses PTSD symptoms such as frequency of nightmares and anxiety levels. More than one year after two or three sessions of MDMA-assisted therapy, about 67% of participants no longer had the illness, according to that scale. About 23% of the control group — who received psychotherapy and a placebo drug — experienced the same benefit.
Researchers leading those trials are now training a cadre of therapists to deliver a form of psychotherapy tailored for use with MDMA, in preparation for the phase III trials. They consider this component essential. “I’ve seen people in my practice who took MDMA at a party and weren’t prepared for the memories that came up, and it was really harmful for them,” says Michael Mithoefer, a psychiatrist in Charleston, South Carolina, and a principle investigator in the MDMA trials.
About 8% of the US population will experience PTSD at some point in their lives. And up to half of participants enrolled in clinical trials to treat PTSD fail to respond to therapies including serotonin-reuptake inhibitors — a class of drugs often used as antidepressants — and cognitive behavioural therapy.
“The results I’ve seen so far with MDMA are so much better than anything I’ve seen so far,” Mithoefer says.

Therapeutic sweet spot

PTSD treatment commonly involves getting a patient to repeatedly recall traumatic events, to extinguish the fear associated with the experience1. But that method can fail if patients can't describe the memory because they have walled it off. Other people have such a charged emotional response that the recollection causes harm. “Because of this stress, many patients will drop out of treatment,” explains Daniel Zuj, a research psychologist at the University of Tasmania in Launceston, Australia, who is not involved in the MDMA trials.
In the 1990s, scientists demonstrated in rodents and humans that MDMA was reasonably safe when taken a few times in a controlled setting. The FDA permitted researchers to move forward with clinical trials exploring the drug as a treatment for PTSD.
Studies suggest that MDMA reduces the fear response1, and triggers the release of serotonin and other neurotransmitters that induce a feeling of well-being2. In this way, individuals may recall events multiple times, in detail, without panicking. “MDMA provides a sweet spot where therapeutic change can happen,” says Mithoefer. “It affects neural networks so that people’s experiences are not hijacked by fear.”

Sustained results

Investigators with MAPS hope to enrol up to 300 people with PTSD to participate in the upcoming phase III trials. The researchers will spend this year training therapists from 14 clinics across North America and Israel to deliver the MDMA-assisted psychotherapy.
They developed their approach by combining modern PTSD therapy with techniques used by LSD researchers in the 1960s. Two therapists supervise the patient while he or she is under the influence of the drug; this lasts five to eight hours for MDMA. It’s essential that people feel they are in a safe, comfortable setting with someone who can oversee the experience, says Alicia Danforth, a clinical psychologist at the Harbor–UCLA Medical Center in Torrance, California, who is involved in MAPS-sponsored trials studying MDMA’s effects on social anxiety in adults with autism.
During his conference presentation, Mithoefer played a video of a former US marine under the influence of MDMA recounting the time his military jeep exploded during a tour in Iraq. The soldier, positioned on a narrow bed between Mithoefer and his wife Annie, a psychiatric nurse, describes the panic that accompanies his memories. But then, he says, an inner-voice assures him that he’ll be all right. “I feel things come up and then blow away like sand,” the marine says. Michael Mithoefer says it’s been five years since the marine’s session. “We are still in touch,” he says, “and that effect has lasted.”

Saturday, April 15, 2017

Wine Industry Finds a Companion in a Competitor: Marijuana

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Phil Coturri, a viticulturist who oversees the vineyard at Kamen Estate in Sonoma, Calif., has also been growing marijuana for almost 40 years. CreditJason Henry for The New York Times
Legal intoxication is big business and getting bigger. More states have legalized marijuana, leading some in the alcohol industry to regard it as a threat to their profit margin.
Those concerns are warranted in some cases. In Colorado, Oregon and Washington, where recreational use has been legal for several years, beer sales are down, mostly among mass-market brews. The liquor industry opposed several marijuana legalization initiatives last year, and has expressed fears for its bottom line.
The fine wine industry, however, has not panicked. Despite occasional efforts to pit wine and weed against each other, people in the wine business exude an air of mellow acceptance that the two substances can coexist in harmony.
“People are trying to say there is a threat, but I really haven’t talked to any wine industry person yet who actually sees it that way,” said Tina Caputo, a freelance wine and food writer, who in August will be a moderator at the first Wine & Weed Symposium. The event, a wine industry initiative, will explore possible business opportunities in California, which legalized recreational marijuana use in November.
“We haven’t actually seen anybody who’s laying down their glass of wine to pick up a bong,” Ms. Caputo said. “There’s room in people’s lives for both.”
Continue reading the main storyRCH 18, 2017
What brings consumers of cannabis (the marijuana industry’s preferred term) together with lovers of wine, craft beer and artisanal spirits is a sense of connoisseurship.
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Friday, April 14, 2017

You Draw It: Just How Bad Is the Drug Overdose Epidemic?


Thursday, April 13, 2017

Virtual Surgery

Not for the squeamish.
http://www.fundamentalvr.com/#

People on ecstasy feel loved-up because MDMA boosts trust




couple

Feeling euphoric

Hector Mediavilla / Picturetank

ECSTASY makes you feel like everyone’s your friend. Now an experiment in which people played a trust game after taking the drug is helping to explain why.
Also called MDMA, ecstasy is known to trigger the release of the brain chemical serotonin, as well as mimicking its actions in the brain. Investigating how this affects us could help us understand how we govern our social actions, and how this process goes awry in depression and schizophrenia, says Anthony Gabay at King’s College London.
In their latest study, Gabay and his team gave 20 men MDMA and asked them to play a game called Prisoner’s Dilemma on a computer while lying in a brain scanner.
The points earned in the game depend on whether you cooperate with or betray your opponent, and on what they choose to do. The game gets more complex if played over a number of rounds, because while you earn the most points on a single round by betraying your opponent, you earn more over time if both people cooperate.
The men played 15 rounds of the game with the same opponent, allowing relationships to build – although unbeknown to them, they were playing against a computer.
When they were given MDMA, they became euphoric and talkative. “Some of them wanted to hug me,” says Gabay. In this state, they cooperated twice as often as when they had played the game after being given a placebo – if their opponent was usually trustworthy.
But if their opponent usually betrayed them, the men acted the same way regardless of whether they had taken MDMA or a placebo, playing less cooperatively. “They were nice but not stupid,” says Gabay. The results were presented at the British Neuroscience Association conference this week.
Brain scans the team took showed that MDMA boosted activity in several brain areas linked to social behaviour, including the right superior temporal sulcus. Recent work has shown the serotonin receptor that is activated by MDMA is found at the highest concentrations in the superior temporal sulci on both sides of the brain, as well as the other areas that became more active in this study.
Michael Mithoefer at the Medical University of South Carolina says the findings help shed light on what MDMA does. “There’s a lot we still don’t know.”
Mithoefer is investigating ecstasy as an aid for treating post-traumatic stress disorder. It may help people trust their therapist more and prevent them from being overwhelmed by their traumatic memories during therapy, he says.

Why Deep Breathing May Keep Us Calm

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CreditGetty Images
For generations, mothers have encouraged children to take long, slow breaths to fight anxiety. A long tradition of meditation likewise uses controlled breathing to induce tranquillity.
Now scientists at Stanford University may have uncovered for the first time why taking deep breaths can be so calming. The research, on a tiny group of neurons deep within the brains of mice, also underscores just how intricate and pervasive the links are within our body between breathing, thinking, behaving and feeling.
Breathing is one of the body’s most essential and elastic processes. Our breaths occur constantly and rhythmically, much like our hearts’ steady beating. But while we generally cannot change our hearts’ rhythm by choice, we can alter how we breathe, in some cases consciously, as in holding our breath, or with little volition, such as sighing, gasping or yawning.
But how the mind and body regulate breathing and vice versa at the cellular level has remained largely mysterious. More than 25 years ago, researchers at the University of California at Los Angeles first discovered a small bundle of about 3,000 interlinked neurons inside the brainstems of animals, including people, that seem to control most aspects of breathing. They dubbed these neurons the breathing pacemaker.
Continue reading the main story
In the years since, though, little progress had been made in understanding precisely how those cells work.
But recently, a group of scientists at Stanford and other universities, including some of the U.C.L.A. researchers, began using sophisticated new genetics techniques to study individual neurons in the pacemaker. By microscopically tracking different proteins produced by the genes in each cell, the scientists could group the neurons into “types.”
They eventually identified about 65 different types of neurons in the pacemaker, each presumably with a unique responsibility for regulating some aspect of breathing.
The scientists confirmed that idea in a remarkable study published last year in Nature, in which they bred mice with a single type of pacemaker cell that could be disabled. When they injected the animals with a virus that killed only those cells, the mice stopped sighing, the researchers discovered. Mice, like people, normally sigh every few minutes, even if we and they are unaware of doing so. Without instructions from these cells, the sighing stopped.
But that study, while literally breathtaking, raised new questions about the capabilities of other neurons in the pacemaker.
So for the newest study, which was published recently in Science, the researchers carefully disabled yet another type of breathing-related neuron in mice. Afterward, the animals at first seemed unchanged. They sighed, yawned and otherwise breathed just as before.
But when the mice were placed in unfamiliar cages, which normally would incite jittery exploring and lots of nervous sniffing — a form of rapid breathing — the animals instead sat serenely grooming themselves.

To better understand why, the researchers next looked at brain tissue from the mice to determine whether and how the disabled neurons might connect to other parts of the brain.
“They were, for mice, remarkably chill,” says Dr. Mark Krasnow, a professor of biochemistry at Stanford who oversaw the research.
It turned out that the particular neurons in question showed direct biological links to a portion of the brain that is known to be involved in arousal. This area sends signals to multiple other parts of the brain that, together, direct us to wake up, be alert and, sometimes, become anxious or frantic.
In the mellow mice, this area of the brain remained quiet.
“What we think was going on” was that the disabled neurons normally would detect activity in other neurons within the pacemaker that regulate rapid breathing and sniffing, says Dr. Kevin Yackle, now a faculty fellow at the University of California, San Francisco, who, as a graduate researcher at Stanford, led the study.
The disabled neurons would then alert the brain that something potentially worrisome was going on with the mouse since it was sniffing, and the brain should start ramping up the machinery of worry and panic. So a few tentative sniffs could result in a state of anxiety that, in a rapid feedback loop, would make the animal sniff more and become increasingly anxious.
Or, without that mechanism, it would remain tranquil, a mouse of Zen.
The implication of this work, both Dr. Krasnow and Dr. Yackle say, is that taking deep breaths is calming because it does not activate the neurons that communicate with the brain’s arousal center.
Whether deep breathing has its own, separate set of regulatory neurons and whether those neurons talk to parts of the brain involved in soothing and pacifying the body is still unknown, although the scientists plan to continue studying the activity of each of the subtypes of neurons within the pacemaker. This area of research is in its infancy, Dr. Yackle says.
It also so far involves mice rather than people, although we are known to have breathing pacemakers that closely resemble those in rodents.
But even if preliminary, this research bolsters an ancient axiom, Dr. Krasnow says. “Mothers were probably right all along,” he says, “when they told us to stop and take a deep breath when we got upset.”

Tuesday, April 11, 2017

$1 Billion In Marijuana Taxes Is Addictive To State Governors

I write about retail and cannabis.  
California believes it will get $1 billion in tax revenue from legalized marijuana.
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California believes it will get $1 billion in tax revenue from legalized marijuana.
States are addicted to cannabis tax revenues. According to a new report from New Frontier Data, states with legalized marijuana are on track to generate approximately $655 million in state taxes on retail sales in 2017. Within that tax figure, $559 million will come just from cannabis taxes, much more than from alcohol taxes.
The report also forecasts that tax revenues in states with legalized marijuana will reach $1.8 billion, of which $1.4 billion will be from cannabis specific taxes. This money isn't easily replaceable if the Department of Justice reviews its current approach to marijuana. Plus, the Trump administration is calling for deep cuts in many programs with its proposed budget and this puts further pressure on state governors to continue providing services its residents have come to expect.
“In an era of dwindling state resources, when we are looking to smaller governments, and an administration at the federal level that is looking to end funding to states in numerous ways, the discovered revenue from regulated legal cannabis markets can be a lifesaver to local law enforcement, substance abuse counseling and other social services,” said Leslie Bocskor of Electrum Partners. According to Bocskor, states are fighting the Justice Department's new war on drugs for purely fiscal reasons because the overall economic impact has been much higher than anyone expected.
“That the states' economies are feeling the effects on real estate, the effects on the job market, the effects on travel and hospitality and the effects from a reduction in taxpayer burden from the criminal justice system,” Bocskor explained. The direct cannabis taxes combined with the indirect taxes such as income tax on newly created jobs and retail taxes on consumer spending from these new jobs has created a tax boom.
Bocskor is right about the unexpectedly large amounts of tax revenue. In Colorado, the state saw a 57.2% increase in the total marijuana taxes collected from FY 2015-16 to FY 2016-17 year-to-date as of January. The retail sales tax alone increased 51.4% for the same period. The state collected $119 million in taxes as of January for its year-to-date fiscal year. Compare this to only $38 million collected on alcohol of at least 11 months in 2016. The money is being put to good use by the state. For example, Colorado was able to put $16 million towards Affordable Housing Grants and Loans in 2016 from cannabis tax collections.
Many states view the cannabis industry as a vice and tax it at a high rate and the industry accepts it as a cost of doing business. It has paid off handsomely for the states that have legalized marijuana. Washington state's cannabis retail tax rate is 37%. The state's total tax obligation for fiscal year 2016 is $185 million and that is expected to increase 25% to $233 million for fiscal year 2017. California will be charging 15% and the state believes it will generate $1 billion and up to $100 million in savings annually. Some of the areas the money will go to include the California Highway Patrol, research, community programs, environmental restoration and law enforcement.
“This tax revenue is very important to them. It's three times as much as alcohol tax and it has quickly become entrenched in the budget,” said Brian Vicente of Vicente Sederberg Law Firm, a firm that specializes in marijuana law. “These governors are fighting the federal government over marijuana laws for two reasons. The first is economic, meaning tax revenue and jobs. The second reason is that it's a better use of law enforcement's time.” He is referring to law enforcement being able to put more time towards violent crime as opposed to low-level marijuana possession arrests.
With virtually every poll showing most Americans approve legalization and governors becoming dependent on the tax revenue to balance the budget and provide more state services, it will be hard to convince these states that rolling back legalization is a good thing.
Vicente said that in places like Colorado, it's very difficult to raise taxes. That state has to go to the voters to raise taxes and most people won't vote for that. The marijuana tax has been a great way to get more revenue and not have to raise taxes elsewhere. “The impact is really felt at the local level. Some counties have done 20 years of infrastructure work in just one year's time,” he said. “They've provided lunch for kids who need it. These are powerful things.”
With cigarette smoking on the decline and gas prices remaining steadily lower, states aren't able to tap traditional areas of easy tax gains. The reality is that consumers don't want higher sales or income taxes, but they still want extra services. Communities that are seeing concrete benefits from these tax dollars are going to be resistant to losing that money. Governors on the front lines of balancing budgets also see what they can do with this money and will fight to keep it.