Associated Press Wire Service
December 27, 2004
FDA OKs Ecstasy study in cancer patients
By Lolita C. Baldor
WASHINGTON — The illegal club drug Ecstasy can trigger euphoria among the dance club set, but can it ease the debilitating anxiety that cancer patients feel as they face their final days?
The Food and Drug Administration has approved a pilot study looking at whether the recreational hallucinogen can help terminally ill patients lessen their fears, quell thoughts of suicide and make it easier for them to deal with loved ones.
“End of life issues are very important and are getting more and more attention, and yet there are very few options for patients who are facing death,” Dr. John Halpern, the Harvard research psychiatrist in charge of the study, said Monday.
The small, four-month study is expected to begin early next spring. It will test the drug’s effects on 12 cancer patients from the Lahey Clinic Medical Center in the Boston area. The research is being sponsored by the Multidisciplinary Association for Psychedelic Studies, a nonprofit group that plans to raise $250,000 to fund it.
MAPS, on its web site, touted the study’s approval, saying “the longest day of winter has passed, and maybe so has the decades-long era of resistance to psychedelic research.”
The FDA would not comment, but this will be the second FDA-approved study using Ecstasy this year. South Carolina researchers are studying the effects of Ecstasy on 20 patients suffering from post traumatic stress disorder.
Ecstasy, known scientifically as MDMA for methylenedioxymethamphetamine, is a chemical cousin of methamphetamine and typically induces feelings of euphoria, increased energy and sexual arousal. But it also suppresses appetite, thirst and the need to sleep, and in high doses can sharply increase body temperature, leading to kidney and heart failure, and death.
It peaked in 2001 as a trendy recreational drug used by youth at gatherings called “raves” and dance clubs.
Halpern, who has done other research on the effects of hallucinogenic drugs, said that some, when used properly, can have medical benefits. He said that unlike LSD, Ecstasy is “ego-friendly,” and unlike some pain medications it does not oversedate people and make them foggy and unsteady.
Instead, he said, it can reduce stress and increase empathy. There are anecdotal reports, he said, of people dying of cancer who take Ecstasy and they are able to talk to their family and friends about death and other subjects they couldn’t broach before.
“I’m hoping that we can find something that can be of use for people in their remaining days of life,” he said. If there are no significant problems, he said broader studies would follow this one.
In addition to FDA approval, the study has also received review board authorization from the Lahey Clinic and Harvard Medical School’s psychiatric facility, McLean Hospital. Halpern is awaiting a license from the federal Drug Enforcement Administration.
It’s been more than 40 years since Harvard has been the site of psychedelic drug research – including the infamous LSD studies of Timothy Leary in 1963 and the Good Friday Experiment in 1965, done by Leary’s student Walter Pahnke, studying the effects of psilocybin mushrooms on religious people.
But “this is not about trying to create some sensationalistic storm,” Halpern said. “This is about trying to help these patients in a meaningful way.”
Learn more about the study by reading the protocol and the consent form for this study. You an also read more about related research with MDMA and psychedelic drugs.
The AP Wire Service published a report on the recent FDA approval of the MDMA/cancer anxiety study, with quotes from principal investigator John Halpern MD.
