DEA Approves Ecstasy for Clinical Trials [Update]

E Ecstasy pills or tablets close up studio shot methylenedioxymethamphetamine. Image shot 2004. Exact date unknown.


The U.S. Drug Enforcement Administration (DEA) has approved the first clinical trial of MDMA to treat anxiety and other psychological illnesses, amid a growing resurgence in therapeutic psychedelic drug usage in the medical community. reports:

“The tide has changed for psychedelic research,” said Brad Burge, the communications director for the Multidisciplinary Association for Psychedelic Studies (MAPS), a California-based nonprofit research group that studies medicinal uses for psychedelics and marijuana and is sponsoring the study. The DEA approved the project on Friday, he said.

Unlike Ecstasy or Molly — names for MDMA sold on the street and often mixed with dangerous adulterants — pure MDMA has been proved “sufficiently safe” when taken a limited number of times in moderate doses, MAPS says on its website. The DEA did not immediately respond to a request for comment.

MDMA can be useful in psychotherapy for people suffering from anxiety due to life-threatening illnesses because it produces in users a sense of calm, trust and confidence, Burge said. Unlike psychedelics such as LSD and psilocybin, MDMA does not produce hallucinations, he added.

The clinical trial will be held in Marin, California, in a psychologist’s office, as opposed to a hospital setting, Burge said. The patients will lie on a couch with a therapist nearby for support and conversation.

In the trial, 18 subjects diagnosed with life-threatening illnesses will attend months of psychotherapy, with MDMA being used in a few sessions in order to facilitate the process, he said. The outcome will be measured by whether using the psychedelic helps reduce people’s anxiety, which will be determined at the end of the sessions by the patient’s feedback and the therapist’s assessments.

Researchers hope that using MDMA alongside psychotherapy will let subjects confront their situation more clearly and allow the positive steps they take during the therapy to “stick,” Burge said. “It opens them up and makes them more comfortable with the therapist while reducing fear and making them more able to talk about difficult emotions.”

If the pilot is successful, MAPS plans to continue with further studies involving more subjects and different approaches. For now, researchers hope to establish basic safety and effectiveness, he said.

The trial is part of a larger $20 million plan to make MDMA an FDA-approved prescription medicine by 2021, Burge said. MAPS is the only organization in the world funding MDMA-assisted psychotherapy trials, he added.

The institute has carried out successful pilot studies of MDMA-assisted psychotherapy for post-traumatic stress disorder, adding to the drug’s scientific credibility, he said. Other research by the institute includes ayahuasca-assisted therapy for drug addiction, LSD for cluster headaches and psilocybin for nicotine addiction.

Researchers hope to back up growing evidence that psychedelics have legitimate therapeutic uses — and to counter the narrative that has demonized them as mind-destroying drugs.

That’s what the really good science shows, despite decades of propaganda and government misinformation,” Burge said. “Just a couple weeks ago, a phenomenal study showed that there are no long-term associations between psychedelic use and mental illnesses.”

That study was published this month in the Journal of Psychopharmacology. In addition, a recent report by Johns Hopkins Medicine, a leading U.S. medical institution combining the Johns Hopkins University School of Medicine and the Johns Hopkins Hospital, showed that the use of psychedelic drugs — primarily psilocybin and LSD — could reduce psychological distress and suicidal thinking.


ecstasy tongue

No link between psychedelics and mental illness? Tell that to this guy...

No link between psychedelics and mental illness? Tell that to this guy…

[Update 5/5/15 1:54pm]

This post is generating a lot of comments on Facebook, mostly positive but not everyone is supportive. Thanks to Maistresse Sybs for sharing this documentary. “This is a major event in drug history…the facts about ecstasy use are astonishing”.

What’s In My Baggie?

Be careful Burners. That Molly might be Bath Salts.

“Molly is the moonshine of today”. As the documentary shows, what people think they’re taking, may not be what they’re really consuming at all.

need lsdA recent Reddit thread discussed how a Burner thought she was taking a lazy 3 hits of LSD at once, but it turned out to be designer drug 2C-C-NBOMe – an invention of the late Burner/Bohemian Grover Sasha Shulgin. She flipped out big time, and had to be restrained to a stretcher and treated at the medical tent. According to Reddit, BMOrg had “compassionate and academic medical staff on hand, with a chromatograph mass spectrometer no less”. They were able to analyze was in the drugs, which led to a medical paper being written for the American Journal of Emergency Medicine.

Case Report: A 24 yo female was found to be tachycardic, tachypneic and with agitated delirium after drinking wine, smoking marijuana and ingesting 3 blotter paper doses of what she thought was lysergic acid diethylamide. She thought she was being attacked by invisible assailants. She was transported from her campsite to an on-site field hospital by emergency medical personnel, where she was treated with intravenous normal saline and lorazepam with complete recovery within 10 hours. Leftover blotter paper samples were analyzed using Agilent Liquid Chromatograph-Time-of-Flight Mass Spectrometer (LC1200-TOF/MS 6230). The primary compound detected was 2C-C-NBOMe, with a smaller amount of 2C-I-NBOMe also present…

just lying around in the Medical Tent.

just lying around in the Medical Tent?

Use of designer drugs is increasing, as evidenced by the well-documented rise of synthetic cannabinoids (herbal incense, spice, K2) and synthetic cathinones (bath salts) in Europe and the United States, the pervasiveness of methylenedioxymethamphetamine (MDMA) in pop culture, and the constant detection of novel compounds with high resolution mass spectrometry techniques. The 2C class of psychedelic phenethylamines was first synthesized by Alexander “Sasha” Shulgin in the 1970s and 1980s. They are 5HT2 receptor agonists with variable receptor activity. Although 2C-I and 2C-B are both 5HT2A receptor agonists, 2C-I also has a high affinity to 5HT2C). Sold as “research chemicals”…

image: Pinterest

image: Pinterest

A 24-year-old Caucasian female with no significant past medical history was screaming in her tent while camping at Burning Man in the Black Rock Desert in Nevada, USA. She was agitated and confused, under the impression that she was being attacked. On initial evaluation, her HR was 140 bpm with RR 32 per minute. Her pupils were dilated to 5 mm and her skin was moist and hot to the touch. She was not oriented to person, place or time. Per her boyfriend, earlier that evening she drank wine and smoked marijuana. Thirty minutes prior to evaluation, she ingested 3 doses of “acid” on blotter paper. She had taken acid (lysergic acid diethylamide, LSD) many times in the past without adverse effect. After brief assessment, paramedics physically restrained her to a gurney and transported her via ambulance to the on-site field hospital. Overnight, she was treated with intravenous normal saline boluses and 2 mg intravenous lorazepam, making a full recovery within 10 hours. The following day, she had complete amnesia to the events that had transpired and was otherwise asymptomatic. Seven other people had ingested single doses from the same blotter paper that evening, but none had similar adverse effects. No one had taken more than one dose. All users had received the drug for free from one supplier. A leftover drug sample was obtained from the supplying party, who had obtained it directly from the producer and was under the impression that it was “25C,” telling the patient that the drug was not acid, but “like acid.”

The American Journal of Emergency Medicine Volume issue 2014 – The electric Kool-Aid NBOMe test

However hardcore you think you are, it’s never a good idea to triple-drop. Especially with something you’ve never done before. Triple the drugs doesn’t mean triple the fun. “But they said it was like acid, I’ve done acid before” – that’s not how drugs work. Maybe if they were decriminalized and regulated, all acid would be the same – but even then “this is like acid”, is not the same as “this new thing you’ve never tried is identical to something else you’ve done before”.

People are handing out free designer drugs at Burning Man, and Burners are getting greedy, and getting into trouble. Who wants to go to a party, and end up as a case study in a medical journal? Or beating off in the cop shop?

Although they say “don’t look a gift horse in the mouth”, I think “know what you’re taking before you take three of it” is better. Safety trumps politeness. Dancesafe sell testing kits here.

Miss Molly Goes to War

by Whatsblem the Pro

CJ Hardin has gone from PTSD to MDMA to A-OK

CJ Hardin has gone from PTSD to MDMA to A-OK

CJ Hardin first went to Burning Man in 2006; when he can make it to Black Rock City he volunteers as a medic. He spins fire staff, and is learning ball poi.

Outside Black Rock City, CJ Hardin is a soldier whose three tours in Iraq and Afghanistan left him an alcohol-soaked, suicidal wreck peppered with physical, emotional, and psychological trauma. The physical damage wasn’t much – some minor injuries, a touch of tinnitus – but the PTSD he suffered picked him up by the scruff of the neck and took him right out of his life.

Michael and Annie Mithoefer are burners, too, and more formally known as Dr. Michael Mithoefer, MD, and his co-therapist, Annie Mithoefer, BSN. The couple run a well-regarded internal medicine practice in Mount Pleasant, South Carolina.

The Mithoefers are currently conducting clinical trials as part of a ten-year, $15,000,000 project that intends to transform MDMA — sometimes sold under the street names Molly, Ecstasy, or X, among others — from an illegal street drug into an FDA-approved prescription medicine. CJ Hardin is a patient in one of those trials.

The project is being administered by a non-profit organization called MAPS, or the Multidisciplinary Association for Psychedelic Studies. MAPS, currently the only organization in the world funding clinical trials of MDMA-assisted psychotherapy, has earned a solid reputation in the scientific community by doing peer-reviewed work on the legitimate medical uses of psychedelics and marijuana since 1986.

To a non-profit organization like MAPS, exploring the medical uses of MDMA makes good sense, because the patent on the drug has expired. This being the case, the for-profit pharmaceutical industry has little or no interest in testing and developing the drug into a product. Once someone like MAPS does it, the for-profit big boys in the big league may manufacture their own version and sell it alongside the patented products they own, but since they can’t hold a monopoly on the drug, there’s no money to be made in doing the groundwork that must come first. This is part of the reason why MDMA has remained on the government’s Schedule 1 list of substances that supposedly have no medicinal value.

All the drugs that MAPS works with either have expired patents, like MDMA, or are unpatentable, like marijuana; once the research allows products to be manufactured from them, nobody – not even MAPS – will have a monopoly on making and selling them, and thus they will likely remain cheap or even free to the people who need them most.

I interviewed CJ Hardin about his progress with the Mithoefers’ MDMA-assisted psychotherapy on Tuesday, November 26th, 2013.

Whatsblem the Pro:
CJ, you’re a burner, right? How did you find your way to Black Rock City the first time?

CJ Hardin:
I went with friends in 2006, after my second Iraq deployment. I really didn’t know much, other than that it was a huge party with cool music and art in the desert. We rented a bus and really kinda glamped it. I didn’t know that it was such a participatory event, but I really started to enjoy it once I began talking to fire spinners, since I had done fancy drill teams with rifles in the JROTC. I had a great time, but also gained a deeper appreciation for the burner community. I really appreciated how Burning Man set itself apart from music festivals I had been to, like the Family Values Tour, and Bonaroo.

Whatsblem the Pro:
How long have you had PTSD, and how long have you been doing the MDMA therapy?

CJ Hardin:
I got deployed in 2003 during the initial push to Baghdad, and served three tours in Iraq and Afghanistan. I started to really feel it after the second deployment.

I’ve been in the MDMA study since midsummer of 2013, and I’m about to do my third MDMA session, on December 3rd. If I haven’t been getting the higher of the two doses they’re testing, I’ll get another five sessions with the high dose after this.

Whatsblem the Pro:
This is a horribly rude question that I wouldn’t ask under other circumstances, but would you mind telling me something about the experiences you had that left you with PTSD?

CJ Hardin:
Well, I’ve been hit by two IEDs while in armored vehicles, but I wasn’t seriously injured, just some hearing loss. I was hit by a bullet fragment from friendly fire that made me think I was shot. . . and pretty much every day we were being targeted with mortar and rocket fire, so we could never really feel safe. On top of that, I was a member of a command team, so I got to see all the operational stuff and the casualties. There was a lot of gory stuff, and friends getting injured and killed. . . and of course never knowing whether a mortar was going to drop on you in your sleep or on the shitter was a really bad feeling that dissociates you from the real world. All of it combined was the problem.

Whatsblem the Pro:
What sort of symptoms did you develop?

CJ Hardin:
Any sudden noise, change of air pressure in the room, motion. . . I’d get hyper-vigilant. Rapid pulse, crippling anxiety. Depression. A need to avoid crowds. Driving became impossible; I’d swerve to avoid anything near the road because it would remind me of IEDs. I got into some major alcohol abuse to keep my mind off stuff. Insomnia. Lack of a sex drive. Thanks to the IEDs, I’ve also got permanent tinnitus, which is a ringing in the ears.

I got to the point where I stayed home and never went out. I didn’t even try to work really, just did odd jobs. I had a lot of suicidal thoughts.

Whatsblem the Pro:
How has the therapy you’ve been doing with the Mithoefers affected all this?

CJ Hardin:
Working with them and with the MDMA has vastly reduced all the symptoms. Some are gone totally. I go out and hike and drive now; I don’t jump as much at all at sudden things; I’m much better with crowds now. Essentially, I realize on a gut level that I’m not at war any more, and I’m safe.

Whatsblem the Pro:
All that, with just two sessions?

CJ Hardin:
Two sessions with the MDMA, and some therapy sessions in between, yes. I’m about to do the third MDMA session.

Whatsblem the Pro:
It sounds like you got your life back.

CJ Hardin:
I did get my life back! There was a profound difference after the first session. . . and my girlfriend benefits by having a sane boyfriend. Did I mention that I lost my marriage due to the PTSD?

Whatsblem the Pro:
I’ve read that a single dose of MDMA might be worth years of psychotherapy.

CJ Hardin:
Oh, yeah. . . eight hours of therapy with MDMA feels like three years of therapy without it.

Whatsblem the Pro:
What went with the MDMA? Were you guided through any particular experience with it, or did they just give it to you and babysit passively?

CJ Hardin:
Oh no, I was totally guided. The doctor and his wife, who is a nurse, were with me the whole time. There was soft music playing, and they gave me a sleeping blindfold in case I wanted to “go inside.” My girlfriend was there for most of the time, too. They let me talk about whatever. Sometimes they would remind me of what I was saying or get me back on a train of thought.

Whatsblem the Pro:
They told you to go inside yourself?

CJ Hardin:
Yep. After I’d talk about something a little more intense, they’d suggest that I go inside and try to feel where I felt the feelings. . . then breathe through it. To dwell on it, kind of.

Whatsblem the Pro:
I can see that happening at a theme camp at Burning Man, too.

Thank you, CJ. This is fascinating research, and from what you’re telling me it seems very promising. Is there anything the community can do to get involved and help?

CJ Hardin:
Actually, yes. . . the study I’m taking part in right now needs funding to continue. It’s all non-profit, and runs on donations, so there’s an Indiegogo campaign that you can give money to. You can read all about the clinical trials and the science and everything there, too.

I really believe that the work the Mithoefers are doing is going to end up helping a lot of people who need help badly and can’t get it because MDMA is illegal. It’s helping me, and I’m very grateful. Please give generously!

Whatsblem the Pro:
Good luck, CJ! We’re rooting for you.