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  1. Terrapinzflyer
    Move over, Advil. A Harvard Medical School researcher says LSD, the hallucinogen at the heart of the 1960s drug counterculture, holds a better treatment for humanity’s worst headaches.

    Harvard researcher John Halpern has formed a company he hopes will bring to market a drug based on his research into the effects of lysergic acid diethylamide on cluster headaches, a rare but devastating condition that is as bad as it sounds.

    Halpern, a noted expert in the long-term effects of drug use, said research suggests chemicals present in LSD are an astonishingly effective cure for cluster headaches. His company, Entheogen Corp., is seeking $10 million to bring the drug through to FDA approval, according to a regulatory filing this week.

    Entheogen’s drug does not cause triptastic visions, Halpern said. It is based on BOL-148, a non-hallucinogenic LSD derivative developed in the 1950s and 60s for research into the effects of LSD on the brain, when such was last in vogue. “Trying to do a double-blind, placebo-controlled trial with a drug that’s as psychoactive as LSD is impossible,” Halpern explained.

    Then, grant funding for such research dried up. Halpern’s Harvard antecedent, Professor Timothy Leary, was expelled from the university, and the culture at large adopted a zero-tolerance policy to drug experimentation.

    Fast forward half a century. Having studied the long-term effects of ritual mescaline use by Native American tribes, Halpern was approached earlier this decade by cluster headache sufferers who said they had found LSD an effective medicine. “It was interesting to hear people talk about the benefits of these drugs,” he said. “You just don’t hear that from alcoholics or heroin addicts.”

    Halpern published an article on the cluster headache sufferers’ experience in 2006, and got grants from Harvard and the National Institute on Drug Abuse to study the impact of BOL-148 on cluster-headache patients. He didn’t expect it to work, he said, but it did.

    He said the results show the drug could be an epigenetic medication, meaning it took some patients from chronic symptoms to episodic with one or two doses. One participant in the study, who had suffered 40 attacks a week for 30 years went to zero a week, Halpern said.

    Cluster headaches are so named because they attack in cycles, coming one after another in waves that can last weeks to months. Patients usually experience long remissions between clusters.

    Existing treatments are limited, Halpern said - but in spite of exposure his work has gotten with articles in scientific journals and a mention on the National Geographic Channel, he’s gotten no interest from big pharma. So, Halpern and Entheogen co-founders Torsten Passie, a professor at Hannover Medical School in Germany, and Ari Mello, a former investment banker with a background in Chinese medicine, hope to bring the product to market themselves. The company name comes from Greek roots meaning ‘God within,’ and refers to any psychoactive substance used in a religious context.

    The climate has changed since the late-1960s backlash, Halpern said. Now, although the danger of abuse is widely recognized, drugs like the painkiller OxyContin and the sedative thalidomide are prescribed. The same could be true of Halpern’s non-hallucinogenic LSD derivative, he said.

    “The difficulty is not anything political or regulatory. It’s just dotting the i’s and crossing the t’s, just as you would for any drug,” Halpern said. “[There is] a little more scrutiny to be sure, but the scrutiny is welcome,” he said.

    Boston Business Journal - by Galen Moore
    Date: Friday, November 5, 2010, 10:33am EDT



  1. Revolvingdoo
    I heard that even when lsd 25 is used It's in sub psychoactive doses?
    Other tryptamines are good for this I hear too such as psylocybin and psylocin, or am I wrong there?
  2. Nnizzle
    No you are right, at least about psilocybin also being used.

    Response of cluster headache to psilocybin and LSD
    Sewell RA, Halpern JH, Pope HG Jr.

    I think that this ^^ concerns psychoactive doses, but if I'm not mistaken there have been real studies that used subpsychoactive.

    Ah, I knew I remembered reading something else about this--here is an article about a non-psychoactive LSD analogue used for cluster headaches. As you can imagine it worked wonders:
    The non-hallucinogen 2-bromo-lysergic acid diethylamide as preventative treatment for cluster headache: An open, non-randomized case series
  3. Terrapinzflyer
    @Revolvingdoo: I have heard Bob Wold, founder/president of Clusterbusters speak, and must say I was blown away at the severity of cluster headaches and what it means for those living with them. Actually say a video of someone in the throes of such a headache and now understand why they are commonly called "suicide headaches"

    There has been minimal scientific research on using psychedelics to treat them (indeed- little is actually understood about them at all)- but the anecdotal reports from those suffering from them strongly points to LSD and Psilocin/psilocybin being the only things that work to treat them. And yes, it seems they are often effective at threshold, or even below threshold doses. There have been mixed reports regarding DMT and a few other psychedelic tryptamines.

    Surely LSD and psilocybin mushrooms are the easiest for these people to get hold of (and in the case of mushrooms grow themselves) - by and large these are desperate people who traditional and alternative medicines have failed - often having tried literally hundreds of traditional drugs/treatments with little or no relief.
  4. Terrapinzflyer
    Start-up searches for cure to headaches
    Firm looks at drug that resembles LSD without side effects

    Six years ago, a 34-year-old man who had suffered from debilitating headaches for nearly two decades contacted a group of Harvard researchers. The extreme pain of his “cluster headaches’’ went away, he told them, during a brief span in his early 20s when he experimented with the hallucinogen LSD.

    Could he, in his youthful indiscretion, have stumbled on a cure?

    Now, in a line of research that stems back to that first report, Harvard Medical School psychiatrist Dr. John H. Halpern has cofounded a company, Entheogen Corp., to try to bring a drug to market for cluster headaches that closely resembles LSD, but does not cause hallucinogenic effects.

    The compound, called BOL-148, was developed and tested in people in the 1950s and ’60s for a very different purpose.

    “People were interested in hallucinogens. It was developed as a placebo for LSD,’’ Halpern said. “Nobody was looking at [the drug] as a treatment for cluster headaches.’’

    Earlier this year, Halpern and coauthors from Hannover Medical School in Germany published a study in Cephalalgia, the journal of the International Headache Society, in which they gave BOL-148 to five people with cluster headaches who had not responded to other treatments.

    The researchers gave the patients three doses of BOL-148 over the course of a week and a half and saw dramatic improvements overall. The patients were followed for 16 weeks, and the side effects were mild, including lightheadedness. There are clear limitations to the study — it was an extremely small sample size, the patients and the doctors knew that they were all receiving the drug, and there was no comparison group of patients given a dummy pill.

    But Entheogen is now trying to raise $10 million to do further testing, with the intent to gather sufficient evidence that the drug could be approved. The company’s work was first reported in Mass High Tech.

    “It’s a tremendous thing,’’ said Rick Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies, a Belmont-based non profit that funds psychedelic and marijuana medical research. “It’s out of the psychedelic community, and it’s a story about the age of the Internet, where patient groups are able to work together and figure stuff out — things the doctors can’t even figure out.’’

    After hearing the 34-year-old man’s tale, Halpern and colleagues used online headache support groups to find people with cluster headaches who reported using LSD or hallucinogenic mushrooms to treat their attacks.

    In a study published in the journal Neurology in 2006, the researchers reported the results of interviewing 53 people. More than half of them had never used hallucinogens except to treat cluster headaches. Nearly two dozen of them said they got relief at doses so low they did not cause hallucination.

    Halpern has studied peyote use in Native American rituals and has a longstanding research interest in the possible medical effects of psychedelic drugs.

    The current story elegantly demonstrates, he says, how such research holds potential for helping patients who suffer from one of the most painful conditions known to medicine. He said one benefit of the compound he hopes to test more broadly is that the drug can be given in much higher doses than LSD.

    “People will pull their hair out to distract them from the pain of the attack; they’ll bang their heads on the wall,’’ Halpern said. “If this type of data continues, then this may offer a paradigm shift in the treatment of cluster headaches.’’

    By Carolyn Y. Johnson
    Globe Staff / November 6, 2010

  5. Terrapinzflyer
    LSD Pill In Development For Debilitating Headaches

    Early Research Shows It Stops Excruciating Cluster Headaches

    BOSTON -- It's psychedelic, hallucinogenic and, of course, illegal.
    The drug LSD comes with a lot of baggage. But now, researchers at McLean Hospital and Harvard are working on an LSD pill they believe will help those suffering from a type of headache so painful, it's been called the "suicide headache."

    It's described as the most excruciating pain one can imagine. Cluster headache sufferers can get them multiple times a day, sometimes for weeks or months at a time.
    Sean Clancy has had cluster headaches most of his life.

    "It feels like someone has your eyeball in a vice and they're just turning it slowly and slowly to the point where you just can't take any more pain," said Clancy.
    Most prescription medications don't work or have dangerous side affects. So to stop the pain, some sufferers have resorted to a highly restrictive, illegal substance: psilocybin. It's more commonly known as "magic mushrooms," an LSD-related hallucinogenic.
    "They would take LSD or psilocybin across 10, 15 days, a few times, and the whole cycle would end early and the remission time between cycles would extend," said Dr. John Halpern of McLean Hospital.

    Back in the '50s and '60s the use of psychedelics for therapeutic study wasn't unusual. But it became taboo after academics like Timothy Leary used LSD on students. He was fired from Harvard for that.

    But fast-forward to today, and that same institution is backing the development of an LSD pill for cluster headaches. It's called B0L-148 -- LSD without the ingredient that makes you hallucinate.

    "It's replacing one hydrogen atom with a bromide that is so large, the LSD can't fit into the receptor that is involved with causing hallucinogenic affects," said Halpern, lead developer of the drug. "The doctor in me is saying 'Wow, wow, wow, This is just amazing.'"
    The pill's been tested on patients in Europe with promising results.

    "One of our subjects had a 27-year history of cluster headaches. A 2- to 3- milligram dose orally of two Bromo LSD on day zero, five, and 10, just three pills, and he went over a year without a single attack. It totally changed his life," said Halpern.

    "Anything with the 'LSD' term is stigmatized," said Dr. Brian McGeeney, assistant professor of neurology at Boston University's school of medicine. "What we don't want to have happen now is that if we have a product that's non-hallucinogenic, we don't want that attribution to stigmatize its study and research for what might be a good indication for treating cluster headaches."

    McGeenney said one of his patients described cluster headaches as feeling like someone is burning half your face off. Clancy agrees. He says he'd welcome any new drug that could keep his nightmare attacks at bay. He hasn't had a cluster headache for four months now and says he's due and dreading its return.

    "You'll jump up like the bed's on fire. But it's not. Your head's exploding," said Clancy.
    BOL-148 is a long way off from FDA approval. Halpern has started his own company to further develop the drug. He and his associates abroad hope to start larger scale clinical trials soon.

    February 9, 2012
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