Feds Stop Stalling, Approve Historic MDMA (Ecstasy) Psychotherapy Study February 27, 2004
Dr. Michael Mithoefer finally obtained a Schedule I license from the Drug Enforcement Administration (DEA) this week to conduct the first U.S. study of MDMA-assisted psychotherapy approved in more than eighteen years. MDMA, commonly known as ecstasy, was outlawed in 1985. Dr. Mithoefer will conduct psychotherapy sessions with twenty victims of violence who suffer from post-traumatic stress disorder (PTSD) and who have not been helped by other treatment strategies. Dr. Mithoefer's research will look in to the assertions of many psychiatrists and psychotherapists who gave ecstasy to their patients to treat PTSD and some forms of anxiety in the years before it was banned.
Though the Food and Drug Administration (FDA) sanctioned Dr. Mithoefer's research in 2001, final approval was hampered by numerous government-regulated Institutional Review Boards that feared approving research with a controversial drug such as MDMA and by a series of DEA hurdles. In 2002, a flawed, $1.3 million federally funded study led by Johns Hopkins University researcher Dr. George Ricaurte erroneously claimed to show that a "common recreational dose regime" of ecstasy causes brain damage to dopamine neurons and could lead to Parkinson's Disease. Meanwhile, the DEA held up on approving Dr. Mithoefer's research until finally giving him his Schedule I license this week, almost two years after his application was filed.
"The last 20 years of MDMA research have belonged to George Ricaurte and
have been focused primarily on neurotoxicity and possible functional
consequences, to the exclusion of other research agendas." said Rick
Doblin, founder and president of the Multidisciplinary Association for
Psychedelic Studies