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PS donated $26,616 to McLean Hospital, Harvard University, for Dr. John Halpern's MAPS-sponsored study of the use of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer.



vir: MAPS - MDMA Research Page






post od matota:



'Ecstasy' Use Studied to Ease Fear in Terminally Ill


By Rick Weiss

Washington Post Staff Writer

Monday, December 27, 2004



This month, in a little-noted administrative decision, the FDA gave the green light to a Harvard proposal to test the benefits of the illegal street drug known as "ecstasy" in patients diagnosed with severe anxiety related to advanced cancer.



Grob is leading an FDA-approved study in which terminally ill cancer patients are being given psilocybin to see whether it can help them sort through emotional and spiritual issues. He said the patients take a "modest" dose of synthetic psilocybin, equivalent to two or three illicit mushrooms. They spend the next six hours or so in a comfortable setting with a psychiatrist -- talking, thinking and sometimes listening to music with headphones.


"So far they have had very impressive results in terms of amelioration of anxiety, improvement of mood, improved rapport with close family and friends and, interestingly, significant and lasting reductions in pain," Grob said of the first few patients to enroll. "These are extraordinary compounds that seem to have an uncanny ability to reliably induce spiritual or religious experiences when taken in the right conditions."




Promising results have also been reported at the University of Arizona from a 10-person study of psilocybin for obsessive-compulsive disorder, which locks people into repetitive thoughts and actions. And Charleston, S.C., psychiatrist Michael Mithoefer has seen no complications in any of the five patients who have enrolled in his 20-person study of MDMA for victims of violence struggling with post-traumatic stress disorder.


With the FDA's Dec. 17 approval of the Harvard MDMA protocol -- and permission in hand from ethics review boards at Harvard and the nearby Lahey Clinic, where patients will be recruited -- the only remaining hurdle is getting a special license from the Drug Enforcement Administration. A dozen subjects with less than 12 months to live will get either low or moderate doses of MDMA during two sessions a few weeks apart, along with counseling and a variety of psychological tests before and after treatment.



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Boston Globe Education section D11-D12 Campus Insider

By Marcella Bombardieri and Jenna Russell | January 16, 2005


ECSTASY AT HARVARD News that a Harvard researcher received Food and Drug Administration approval to study the effects of the illegal drug known as ecstasy on terminal cancer patients brought a bonanza of publicity, including coverage on CNN and the "Today" show. Much of the interest seemed to revolve around the return of psychedelic research to Harvard, where Timothy Leary lost his job in the 1960s after using students in his drug experiments.


But more amazing to some is the fact that the federal government is allowing McLean Hospital to do a study with 3,4 methylenedioxymethamphetamine, or MDMA, while blocking a University of Massachusetts professor from simply growing marijuana for research. Both projects are funded by the same organization, the Multidisciplinary Association for Psychedelic Studies, whose president, Rick Doblin, said authorities seem to have a special dislike for marijuana research because many people have used the drug recreationally, making it more vital to maintain its illegitimacy. He also notes that different agencies have different approaches. The FDA is open to research, while the Drug Enforcement Administration controls the marijuana supply so tightly that research is nearly impossible, he said.


Doblin hopes to get approval soon for another Harvard study, testing LSD for treating cluster headaches. "The government has invested more of the war on drugs on marijuana than psychedelics," he said. "The first thing they taught us at the Kennedy School is, 'Don't expect your government to be consistent.' "


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  • 5 weeks later...

The Guardian

February 17, 2005




Ecstasy trials for combat stress


David Adam, science correspondent


[MAPS Comment: This is not a new study of MDMA-assisted therapy in people with PTSD. Rather, it is a change in the scope of a study that is already underway. This study originally allowed only people who had PTSD as the result of crime victimization to take part in the study. However, Dr. Mithoefer and MAPS requested and recieved permission from the IRB overseeing the study and the FDA to let people with combat-related PTSD take part in the study as well, so long as their diagnosis has remained for no longer than five years. You can read more about this change in the study in the February, 2005 MAPS newsletter.]


American soldiers traumatised by fighting in Iraq and Afghanistan are to be offered the drug ecstasy to help free them of flashbacks and recurring nightmares. The US food and drug administration has given the go-ahead for the soldiers to be included in an experiment to see if MDMA, the active ingredient in ecstasy, can treat post-traumatic stress disorder.


Scientists behind the trial in South Carolina think the feelings of emotional closeness reported by those taking the drug could help the soldiers talk about their experiences to therapists. Several victims of rape and sexual abuse with post-traumatic stress disorder, for whom existing treatments are ineffective, have been given MDMA since the research began last year.


Michael Mithoefer, the psychiatrist leading the trial, said: "It's looking very promising. It's too early to draw any conclusions but in these treatment-resistant people so far the results are encouraging.


"People are able to connect more deeply on an emotional level with the fact they are safe now."


He is about to advertise for war veterans who fought in the last five years to join the study.


According to the US national centre for post-traumatic stress disorder, up to 30% of combat veterans suffer from the condition at some point in their lives.


Known as shell shock during the first world war and combat fatigue in the second, the condition is characterised by intrusive memories, panic attacks and the avoidance of situations which might force sufferers to relive their wartime experiences.


Dr Mithoefer said the MDMA helped people discuss traumatic situations without triggering anxiety.


"It appears to act as a catalyst to help people move through whatever's been blocking their success in therapy."


The existing drug-assisted therapy sessions last up to eight hours, during music is played. The patients swallow a capsule containing a placebo or 125mg of MDMA - about the same or a little more than a typical ecstasy tablet.


Psychologists assess the patients before and after the trial to judge whether the drug has helped.


The study has provoked controversy, because significant doubts remain about the long-term risks of ecstasy.


Animal studies suggest that it lowers levels of the brain chemical serotonin, and some politicians and anti-drug campaigners have argued that research into possible medical benefits of illegal drugs presents a falsely reassuring message.


The South Carolina study marks a resurgence of interest in the use of controlled psychedelic and hallucinogenic drugs. Several studies in the US are planned or are under way to investigate whether MDMA, LSD and psilocybin, the active ingredient in magic mushrooms, can treat conditions ranging from obsessive compulsive disorder to anxiety in terminal cancer patients.

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  • 2 weeks later...
  • 1 year later...

This year, the drug MDMA, otherwise known as ecstasy, could take a step toward medical respectability. Researchers in South Carolina have begun experimenting with MDMA for patients with post-traumatic stress disorder. At Harvard, a long-awaited pilot study will begin on whether the drug can help relieve anxiety and pain in terminal cancer patients in connection with psychotherapy. And studies will also start in Switzerland and Israel, where a former chief psychiatrist of the Israel Defense Forces will oversee work with people whose PTSD stems from terrorism or war.


Ecstasy gained notoriety as a party drug in the 1980s and 1990s. (Recall teenagers at raves with sparkly eyes and pacifiers rolling and dancing all night; a revival appears to be under way in England.) Enthusiasts say the drug makes them feel relaxed, energetic, and mentally clear. One likened it to a six-hour orgasm. In rare cases, however, users died after dancing for hours and overheating, or after taking mixtures of ecstasy and other drugs. Animal studies have shown that long-term, heavy ecstasy use can be risky for the brain. Human studies have found some ill effects in chronic users, as well. The government classifies MDMA (or 3,4-methylenedioxymethamphetamine) along with heroin, LSD, and marijuana as a Schedule 1 drug, which means that it's illegal and has no recognized medical uses.


But research has not proved that moderate or low doses of ecstasy are particularly dangerous. And avant-garde psychiatrists have long argued that in a controlled clinical setting, low amounts can play a role by reducing fear, without sedation, and so encourage openness and emotional insight. "There is nothing else like this in psychiatry—a fast-acting anti-anxiety medication that makes people alert and talkative," says Julie Holland, a psychiatrist at NYU Medical Center. If available to treat patients, "It would be incredibly useful." Some mental-health professionals interested in exploring MDMA's therapeutic uses protested when the government made it illegal 20 years ago. Stories of the drug's power to combat the psychological effects of terminal illness have continued to surface over the years. But proponents have had little but anecdote to go on. The current wave of studies should bring new rigor to answering an old question: whether MDMA deserves to be a prescription drug.




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  • 1 year later...

Drugs classification should be scrapped, experts say



A leading think-tank has called for the Government’s system of drugs classification to be scrapped.



The UK Drugs Policy Commission says classifying illegal drugs on a “danger scale” of classes A, B or C needs to be overhauled because they do not affect drug use.


The news comes ahead of a meeting this Friday when the Home Office’s independent Advisory Council on the Misuse of Drugs will discuss whether to downgrade ecstasy from class A.


Ecstasy remains the third most popular illicit drug in Britain, with five per cent of young adults aged 16 to 24 saying they have used it in the last year.


The council, which is made up of 21 academics and drugs experts, provides advice to Governments on illegal drug use and is expected to recommend downgrading the drug from A to B.


Reports from the Police Foundation in 2000, the Commons Home Affairs Committee in 2002 and the Commons Science and Technology Committee in 2006 have all favoured the move.


However the Commission warned the council in a submission that Home Secretary Jacqui Smith is likely to over-rule any decision to downgrade, in a re-run of the row over cannabis earlier this year.


Then, the council's recommendation that cannabis should remain a class C drug was ignored by Miss Smith who decided to reclassify the drug on health grounds.


The Commission says: “The UKDPC does not want to second-guess the council’s final conclusions about ecstasy. However were it to recommend a lower classification then it is not unreasonable to anticipate a political response to that with cannabis.”


The Commission was heavily critical of what it describes as the “increased polticisation” of drugs’ classification.


Roger Howard, Chief Executive, UK Drug Policy Commission, told The Daily Telegraph yesterday: “The purpose and operation of the drug classification system has become increasingly confused amongst politicians and the public in recent years.


“The time has come for an independent wholesale review of the system to clarify how a scientific rating of drug harms should be used for drug classifications and for wider applications such as setting policing priorities or public health messages.”


Members of the commission include the chairman Dame Ruth Runciman, a former council member who chaired a Police Foundation inquiry which argued for ecstasy to be moved to class B seven years ago, Professor Colin Blakemore, the former chief executive of the Medical Research Council and David Blakey, a former Chief Constable and HM inspector of constabulary.


The council is expected to make its decision on ecstasy next year. :)



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