From sfraves-request@medisg.Stanford.EDU Fri Nov 13 11:39:52 1992 Received: from medisg.Stanford.EDU by soda.berkeley.edu (5.65/KAOS-1) id AA18747; Fri, 13 Nov 92 11:39:47 -0800 Received: by medisg.Stanford.EDU (4.1/1.34) id AA29249; Fri, 13 Nov 92 11:32:43 PST Received: from soda.berkeley.edu by medisg.Stanford.EDU (4.1/1.34) id AA29245; Fri, 13 Nov 92 11:32:40 PST Received: from gatekeeper.oracle.com by soda.berkeley.edu (5.65/KAOS-1) id AA18599; Fri, 13 Nov 92 11:32:59 -0800 Received: from slamdance.us.oracle.com by gatekeeper.oracle.com (5.59.11/37.7) id AA26104; Fri, 13 Nov 92 11:32:32 PST Received: by slamdance.us.oracle.com (5.59.10/37.3) id AA24285; Fri, 13 Nov 92 11:32:14 PST Message-Id: <9211131932.AA24285@slamdance.us.oracle.com> Date: Fri, 13 Nov 92 11:32:14 PST From: Derek Chung To: sfraves@soda.berkeley.edu, socal-raves@ucsd.edu Subject: FDA gives approval to testing of Ecstasy Status: R from yesterday's SF Examiner [I guess they think somebody in the community is interested in this :) ] FDA gives approval to testing of Ecstasy By Sarah Pekkanen States News Service (reprinted without permission) WASHINGTON - In an unprecedented decision, the Food and Drug Administration has cleared the way for a UC-Irvine researcher to study the effects of a hallucinogenic drug known as MDMA, or Ecstasy, on human subjects. Dr. Charles Grob last week won FDA approval for his study, expected to take place at the campus in two months. During Grob's study, six health professionals, who have not yet been selected, will take two low-level doses of the drug and a placebo during three separate sessions to determine the effect of the drug. The FDA approval is a major breakthrough for researchers who have, with few exceptions, been denied permission to administer hal- lucinogens, including LSD, to human subjects since officials moved to outlaw the drugs in the late 1960s. Rick Doblin, president of a non-profit organization called the Multidiscipliary Association for Psychedelic Studies, said the subjects will be volunteers who all took Ecstasy before it was outlawed by the FDA in 1985. The subjects have already assumed any risks associated with the drug, which may also have contributed to the FDA approval, Doblin said. The six volunteers participating in the drug study will be subject to a battery of non- invasive tests, including mood status, analysis of pain reduction and cognitive tests, said Grob. Grob still has two more hurdles to clear before his study can take place: He must win approval from the Drug Enforcement Administration and the California Research Advisory Panel. Doblin said he did not expect either agency to oppose the study. The drug Ecstasy has been reported to increase self-confidence and self-acceptance and induce feelings of empathy and love, which could make it a useful tool for psychotherapists, some researchers say. Although negative side effects of the drug include decreased appetite and decreased desire to perform mental or physical tasks, the drug may also help alleviate pain, which could benefit certain terminally ill patients, Doblin said. Grob said he hopes to eventually win FDA approval for a study that would involve administering the drug to end-stage cancer patients. ________________________________________________ Derek Chung Oracle Graphics dhchung@oracle.com (415)506-6195