Scientists from the Multidisciplinary Association for Psychedelic Studies (MAPS) are hoping to help 18 terminally ill patients relieve their anxiety, depression, and fear in the next year during extended psychotherapy sessions enhanced by MDMA (ecstasy). The Marin County-based double-blind trial will see subjects test either full doses of MDMA (125 milligrams) or active placebo doses (30 milligrams).
Principal investigator and San Anselmo psychiatrist Dr. Philip Wolfson says that the MDMA-assisted sessions, which will last four to five hours, may be "transformationally potent." The team expects results within 12 to 15 months.
The full dose subjects will have the choice to take another 62.5 milligram dose within the parameters of the same session.
"So with a lower dose of MDMA in the active placebo, it might fool the subject or the therapist. And by giving people the option of following up with another half dose, it just extends the window for therapy rather than making it more intense," says Brad Burge, spokesman for MAPS.
Ecstasy has been an illegal drug for thirty years, but the MAPS team sees amazing potential in its use under controlled settings.
"Our hypothesis is that something is happening with MDMA that makes psychotherapy easier," Burge says.
The US Food and Drug Administration (FDA) has granted Wolfson and his team permission to conduct the MDMA study. MAPS has also received a license from the US Drug Enforcement Administration (DEA) to administer the ecstasy to subjects.
FDA spokeswoman Sandy Walsh said that the agency agrees that previous MDMA studies indicate that research subjects can use ecstasy safely under medical supervision.
"If a drug works for a disabling condition and can be labeled to be used in a safe way in that population, then we think we have an obligation to evaluate the data and do what the data support, such as allow a trial to proceed" Walsh says.
Dr. Thomas Insel, director of the National Institute of Mental Health (NIMH), is among those in federal government who find this kind of treatment compelling.
"It's a really interesting and a very powerful new approach," Insel says. "It's not just taking MDMA. It's taking it in the context of a treatment that involves improved insight and increased skills and using this in the broader context of psychotherapy."
The use of MDMA, a psychoactive drug, within therapy is a radically unique approach to treating serious anxiety. It isn't sedating, and a several hour psychedelically enhances session can be "transformationally potent" within a comfortable, safe, supervised setting, says Wolfson.
"It's a substance that supports deep, meaningful and rapidly effective psychotherapy," says Wolfson.
Wolfson is no stranger to intensive therapy and its role in helping people cope with personal traumas. The researcher lost his son to leukemia years ago, and since that time Wolfson has been hoping to help others facing emotional turmoil.
Study participants will first complete preliminary therapy. Afterwards the participants will receive experimental eight-hour therapy sessions; thirteen of them will receive the full dose drug and five will get the placebo dose. In the following months researchers will assess and compare the mental health of the participants with counseling and psychological testing.
The placebo participants can later undergo actual MDMA sessions.
"We're not just sitting in an office for 50 minutes," Wolfson says. "We go for as long as we need in a warm, friendly atmosphere. We get very close to these people. This is a revolution in therapy and needs a different approach."
MAPS has already had some success with MDMA-assisted therapy. They have studied the technique with Iraq War veterans and sexual abuse victims experiencing PTSD. In this study MAPS researchers found that four of five patients radically improved. That paper was published in the Journal of Psychopharmacology.
"MDMA can help us experience awe, and that eases anxiety and depression," says Julane Andries, a licensed family therapist and Wolfson's partner. "Later, you can hold onto that memory of feeling vital, alive, happy and full of awe."
In 1985 ecstasy was classified by the federal government as a Schedule I drug, subjecting MDMA to the strictest narcotics prohibition under federal law. Part of this move was a federal determination that the drug was "without medical value."
Wolfson and the MAPS team aim to persuade federal agencies like the DEA and FDA to reclassify ecstasy for medical use. Results from this experiment and the previous studies with PTSD victims may well allow them to do it.
In reality, many scientific and medical experts recognize the value in this type of application for MDMA.
John Hartberg, the neuroscience study coordinator, says that mainstream culture has begun to "accept the validity of altered, nonlinear states of reality" and that "mystical or spiritual experiences are powerful and an essential part of healing."
"This is becoming a totally legitimate and exploding field with so much potential," says Hartberg. "This is no longer a fringe thing."
