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Start-up searches for cure to headaches

Firm looks at drug that resembles LSD without side effects

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

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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.’’

Carolyn Y. Johnson can be reached at cjohnson@globe.com.