from the touchy-subject dept.
Australian Cate Faehrmann may be the world's first politician to admit to having used the illicit drug MDMA. The reaction in Australia, and globally, has surprised her, she tells Gary Nunn in Sydney.
Ms Faehrmann's admission, made in January, has come amid a fierce debate about introducing "pill testing" services in New South Wales (NSW). Five music festival-goers have died from suspected drug overdoses in NSW since September. It has prompted passionate calls for action - but state lawmakers are divided on what should be done.
Ms Faehrmann, 48, from the Greens party, argues that her opponents have a "limited understanding of the people they're needing to connect with". She says she has taken MDMA (known as ecstasy when in pill form) "occasionally" since her 20s. "I'm sitting here as a politician with more experience than anyone else in the building," she says, adding: "Maybe not - maybe I'm the only one being honest."
NSW Premier Gladys Berejiklian is opposed to pill testing. She has said that "no evidence [has been] provided to the government" that it saves lives, and that testing would give drug users "a false sense of security".
[*] MDMA: 3,4-Methylenedioxymethamphetamine:
3,4-Methylenedioxymethamphetamine (MDMA), commonly known as ecstasy (E), is a psychoactive drug primarily used as a recreational drug. The desired effects include altered sensations and increased energy, empathy, and pleasure. When taken by mouth, effects begin after 30–45 minutes and last 3–6 hours.
The clinical trials at N.Y.U.—a second one, using psilocybin to treat alcohol addiction, is now getting under way—are part of a renaissance of psychedelic research taking place at several universities in the United States, including Johns Hopkins, the Harbor-U.C.L.A. Medical Center, and the University of New Mexico, as well as at Imperial College, in London, and the University of Zurich. As the drug war subsides, scientists are eager to reconsider the therapeutic potential of these drugs, beginning with psilocybin. (Last month The Lancet, the United Kingdom's most prominent medical journal, published a guest editorial in support of such research.) The effects of psilocybin resemble those of LSD, but, as one researcher explained, "it carries none of the political and cultural baggage of those three letters." LSD is also stronger and longer-lasting in its effects, and is considered more likely to produce adverse reactions. Researchers are using or planning to use psilocybin not only to treat anxiety, addiction (to smoking and alcohol), and depression but also to study the neurobiology of mystical experience, which the drug, at high doses, can reliably occasion. Forty years after the Nixon Administration effectively shut down most psychedelic research, the government is gingerly allowing a small number of scientists to resume working with these powerful and still somewhat mysterious molecules.
As I chatted with Tony Bossis and Stephen Ross in the treatment room at N.Y.U., their excitement about the results was evident. According to Ross, cancer patients receiving just a single dose of psilocybin experienced immediate and dramatic reductions in anxiety and depression, improvements that were sustained for at least six months. The data are still being analyzed and have not yet been submitted to a journal for peer review, but the researchers expect to publish later this year.
The results taste orange.
Tripping up addiction: the use of psychedelic drugs in the treatment of problematic drug and alcohol use (DOI: 10.1016/j.cobeha.2016.10.009) (DX)
Psychedelics not linked to mental health problems or suicidal behavior: A population study (open, DOI: 10.1177/0269881114568039) (DX)
In small studies around the country, a handful of researchers have been investigating how MDMA-assisted psychotherapy can help heal the psychological and emotional damage caused by sexual assault, war, violent crime, and other traumas. Now, federal regulators have approved the drug for use in large-scale clinical trials too—a move that could set the stage for making "ecstasy" legally available as a new medicine. The Phase III trials will involve at least 230 patients, and will be sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), an organization that advocates for the medical use of various psychedelics, including MDMA (otherwise known as ecstasy or Molly or millennial aspirin). The organization funded early safety and efficacy trials of the drug in the past. And in one pilot study involving 19 PTSD patients, more than half experienced decreased symptoms for up to six years after receiving three doses of MDMA.
The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to MDMA for the treatment of posttraumatic stress disorder (PTSD). MAPS and the FDA have also reached agreement under the Special Protocol Assessment Process (SPA) for the design of two upcoming Phase 3 trials (MAPP1 and MAPP2) of MDMA-assisted psychotherapy for patients with severe PTSD.
MDMA-assisted psychotherapy is a novel treatment package that combines psychotherapeutic techniques with three administrations of MDMA as a pharmacological adjunct. By granting Breakthrough Therapy Designation, the FDA has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD.
The first Phase 3 trial (MAPP1), "A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder," will begin enrolling subjects in Spring 2018, after the completion of an open-label lead-in training study at Phase 3 sites starting this fall.
[...] The Phase 3 trials will assess the efficacy and safety of MDMA-assisted psychotherapy in 200-300 participants with PTSD, aged 18 and older, at sites in the U.S., Canada, and Israel. Participants will be randomized to receive three day-long sessions of either MDMA or placebo in conjunction with psychotherapy over a 12-week treatment period, along with 12 associated 90-minute non-drug preparatory and integration sessions. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.
In MAPS' completed Phase 2 trials with 107 participants, 61% no longer qualified for PTSD after three sessions of MDMA-assisted psychotherapy two months following treatment. At the 12-month follow-up, 68% no longer had PTSD. All Phase 2 participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.8 years.
Since 2012, FDA has designated close to 200 drugs as breakthrough therapies, a status that indicates there's preliminary evidence that an intervention offers a substantial improvement over other options for a serious health condition. The agency aims to help develop and review these treatments faster than other candidate drugs.
Scientists have discovered that your ordinary, everyday octopus can get "high" on MDMA just like humans. While intoxicated with "molly", an octopus is likely to be more social and friendly towards others, changing from being antisocial to highly social, much like how the drug affects humans.
Human and octopus lineages are separated by over 500 million years of evolution and show divergent anatomical patterns of brain organisation, which makes this find surprising. This may make the octopus an attractive test subject for future drug trials.
In order to test the theory that an octopus is affected by MDMA in the same way as a human, an octopus was submerged in a tank of water mixed with MDMA, and later put into a series of three connected chambers, one of which had a caged octopus underneath. The stoned octopus chose to spend its time trying to play with the caged octopus, in a complete reversal of sober octopus nature.
A Conserved Role for Serotonergic Neurotransmission in Mediating Social Behavior in Octopus (open, DOI: 10.1016/j.cub.2018.07.061) (DX)