A South Carolina psychiatrist said Wednesday he will immediately start recruiting patients after winning approval to conduct the first study testing MDMA -- better known as ecstasy -- as a therapeutic tool.
Dr. Michael Mithoefer plans to conduct psychotherapy sessions with 20 women who suffer from post-traumatic stress disorder due to sexual assaults or other violence, and who haven't been helped by other treatment. Twelve of the women will receive MDMA prior to the sessions while eight will be given a placebo.
The Food and Drug Administration approved Mithoefer's protocol in 2001, but it took another two years to find an institutional review board willing to sanction the study, which is a required step when dealing with human research subjects.
Mithoefer's research required approval from the Drug Enforcement Administration because MDMA is a Schedule I drug. It's grouped with drugs like heroin, cocaine and LSD, all considered to have no medical use.
Bill Grant, a spokesman for the DEA, said the final approval came Tuesday night.
Mithoefer says he works with post-traumatic stress disorder patients all the time and he's excited about the possibility of finding a better treatment for the hundreds of thousands of Americans who suffer from the sometimes debilitating disorder.
"We owe it to them," he said. "It would be irresponsible for the medical community not to investigate something like this."
At the same time, he warns that using MDMA in an uncontrolled setting can be very dangerous.
"It's really important for people to realize the fact that we have permission to do this study and we can do it safely in this setting," he said.
Also, the fact that he's received permission for the study, he said, "does not mean that you can use ecstasy safely and anywhere."
MDMA was first invented in 1912 but largely ignored until young people made it a recreational drug starting in the late 1970s. Psychiatrists quickly became aware of its unusual properties, and several dozen experimented by giving MDMA to patients -- including people suffering post-traumatic stress disorder -- and others with intense anxiety after receiving diagnoses of terminal cancer.
One of those patients from the early 1980s is an artist now living in the western United States, who spoke with CNN. She did not want her name used.
After being raped and beaten at age 17, the woman suffered severe panic attacks for eight years, leading to three hospitalizations before being treated with MDMA. Before those sessions, she said her trauma was misdiagnosed as schizophrenia, severe depression and bipolar disorder.
"MDMA allowed me, for the first time, to sit with the details of the event, and separate them from what was happening in the present," she told CNN. "I was able to relax my body. I was able to say, 'this is not happening to you right now.' "
Suicidal at the time, she said the treatment may have saved her life.
"There might have been another way, but the way that I see it is that I probably would have died," she said.
"When someone is traumatized, walls form around trauma -- like a scar -- and it's hard to get someone to open up and talk about it," explains Dr. Julie Holland of New York University, author of "Ecstasy: A Complete Guide."
"What's unique about MDMA is that it's actually stimulating but decreases anxiety," Holland told CNN. "It could help people feel calm and comfortable enough to explore painful things that are hard to talk about."
"A good analogy is that it would give psychiatry something akin to anesthesia during therapy," she said. "And unlike anesthesia, your memory is completely intact, but even enhanced. You remember the trauma very clearly, but are comfortable enough to talk about it."
"Because it anesthetizes the patient to some extent," Holland said, "you can get to that malignant core in one or two sessions instead of three or four years."
But Dr. Scott Lillienfeld, a psychiatrist at Emory University who has studied post-traumatic stress disorder, said that hypothesis is "at the least, muddled."
Lillienfeld said effective treatment actually requires the patient to face their trauma head-on. "If you're calm, you're not getting at the root of the problem," said Lillienfeld.
He also said Mithoefer's study has methodological problems.
"There's no real placebo," he said. "Everyone will know who's on the drugs. What I wonder is, instead of a placebo, why aren't they giving a drug that mimics the physical effects?"
Mithoefer said all participants will have to undergo psychiatric screening and a physical exam to ensure they don't have any physical risk factors. Ecstasy, a strong stimulant, is thought to be particularly dangerous to people with high blood pressure. It also has been known to cause dangerous overheating in people who take it and then exercise or dance for a long period of time.
Patients in this clinical trial will be given the drug only one or two times. They will be under a doctor's supervision for the entire time they are under the drug's influence.
Mithoefer said he hopes to begin the actual therapy sessions next month.
CNN producers Caleb Hellerman and Miriam Falco contributed to this report.
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Ecstasy approved for medical study
Wednesday, February 25, 2004
CNN
http://www.cnn.com/2004/HEALTH/02/25/ecstasy.study/index.html
[edit: just cleaned up format]
Dr. Michael Mithoefer plans to conduct psychotherapy sessions with 20 women who suffer from post-traumatic stress disorder due to sexual assaults or other violence, and who haven't been helped by other treatment. Twelve of the women will receive MDMA prior to the sessions while eight will be given a placebo.
The Food and Drug Administration approved Mithoefer's protocol in 2001, but it took another two years to find an institutional review board willing to sanction the study, which is a required step when dealing with human research subjects.
Mithoefer's research required approval from the Drug Enforcement Administration because MDMA is a Schedule I drug. It's grouped with drugs like heroin, cocaine and LSD, all considered to have no medical use.
Bill Grant, a spokesman for the DEA, said the final approval came Tuesday night.
Mithoefer says he works with post-traumatic stress disorder patients all the time and he's excited about the possibility of finding a better treatment for the hundreds of thousands of Americans who suffer from the sometimes debilitating disorder.
"We owe it to them," he said. "It would be irresponsible for the medical community not to investigate something like this."
At the same time, he warns that using MDMA in an uncontrolled setting can be very dangerous.
"It's really important for people to realize the fact that we have permission to do this study and we can do it safely in this setting," he said.
Also, the fact that he's received permission for the study, he said, "does not mean that you can use ecstasy safely and anywhere."
MDMA was first invented in 1912 but largely ignored until young people made it a recreational drug starting in the late 1970s. Psychiatrists quickly became aware of its unusual properties, and several dozen experimented by giving MDMA to patients -- including people suffering post-traumatic stress disorder -- and others with intense anxiety after receiving diagnoses of terminal cancer.
One of those patients from the early 1980s is an artist now living in the western United States, who spoke with CNN. She did not want her name used.
After being raped and beaten at age 17, the woman suffered severe panic attacks for eight years, leading to three hospitalizations before being treated with MDMA. Before those sessions, she said her trauma was misdiagnosed as schizophrenia, severe depression and bipolar disorder.
"MDMA allowed me, for the first time, to sit with the details of the event, and separate them from what was happening in the present," she told CNN. "I was able to relax my body. I was able to say, 'this is not happening to you right now.' "
Suicidal at the time, she said the treatment may have saved her life.
"There might have been another way, but the way that I see it is that I probably would have died," she said.
"When someone is traumatized, walls form around trauma -- like a scar -- and it's hard to get someone to open up and talk about it," explains Dr. Julie Holland of New York University, author of "Ecstasy: A Complete Guide."
"What's unique about MDMA is that it's actually stimulating but decreases anxiety," Holland told CNN. "It could help people feel calm and comfortable enough to explore painful things that are hard to talk about."
"A good analogy is that it would give psychiatry something akin to anesthesia during therapy," she said. "And unlike anesthesia, your memory is completely intact, but even enhanced. You remember the trauma very clearly, but are comfortable enough to talk about it."
"Because it anesthetizes the patient to some extent," Holland said, "you can get to that malignant core in one or two sessions instead of three or four years."
But Dr. Scott Lillienfeld, a psychiatrist at Emory University who has studied post-traumatic stress disorder, said that hypothesis is "at the least, muddled."
Lillienfeld said effective treatment actually requires the patient to face their trauma head-on. "If you're calm, you're not getting at the root of the problem," said Lillienfeld.
He also said Mithoefer's study has methodological problems.
"There's no real placebo," he said. "Everyone will know who's on the drugs. What I wonder is, instead of a placebo, why aren't they giving a drug that mimics the physical effects?"
Mithoefer said all participants will have to undergo psychiatric screening and a physical exam to ensure they don't have any physical risk factors. Ecstasy, a strong stimulant, is thought to be particularly dangerous to people with high blood pressure. It also has been known to cause dangerous overheating in people who take it and then exercise or dance for a long period of time.
Patients in this clinical trial will be given the drug only one or two times. They will be under a doctor's supervision for the entire time they are under the drug's influence.
Mithoefer said he hopes to begin the actual therapy sessions next month.
CNN producers Caleb Hellerman and Miriam Falco contributed to this report.
--------------------------------------------------------------------------
Ecstasy approved for medical study
Wednesday, February 25, 2004
CNN
http://www.cnn.com/2004/HEALTH/02/25/ecstasy.study/index.html
[edit: just cleaned up format]
Last edited by a moderator:
