FIG1 Can the same drug that in
the past decade has found a niche among young people during rave parties at
crowded dance clubs also help terminally ill patients face their fears and
resolve issues with loved ones in their final days?
John Halpern, M.D.: MDMA "allows people to talk about things they
would normally avoid discussing."
A Harvard researcher, psychiatrist John Halpern, M.D., received approval in
December from the U.S. Food and Drug Administration (FDA) to answer this
question in a pilot study this spring in which he will administer
MDMA—the drug commonly known as ecstasy—in conjunction with
psychotherapy to 12 patients with advanced-stage cancer.
Halpern is associate director of substance abuse research at McLean
Hospital in Belmont, Mass., and has conducted several studies on the
neurocognitive effects of hallucinogens.
MDMA shares similarities with amphetamine and with the hallucinogen
mescaline in regard to its chemical structure and pharmacologic properties. In
prior research, it has been known to induce "increased feelings of
rapport with others, increased sensitivity to emotions, and increased insights
about the self," according to a summary of the newly approved study.
"MDMA can reduce anxiety significantly and bring a sense of calm and
empathy," Halpern told Psychiatric News. "It allows
people to talk about things they would normally avoid discussing," he
said, because the topics typically trigger anxiety attacks.
To participate in the study, subjects must have less than a year to live
and meet DSM-IV criteria for anxiety disorder due to a general
The subjects will either have not responded to treatment with anxiolytic
medications or will have refused treatment with these medications.
Throughout the trial they will be encouraged to share their thoughts and
emotions relating to their medical condition.
Patients will first receive several hour-long sessions of psychotherapy
with Halpern and/or his colleague, psychiatrist Umadevi Naidoo, M.D., during
which they will talk with patients about current symptoms, discuss impairment
caused by anxiety, and help patients identify triggers for episodes of
anxiety, for example.
In addition, the researchers will prepare the subjects for two experimental
sessions in which they will be randomized to receive either a low or moderate
dose of MDMA—this will involve a discussion of the subjects'
expectations and intentions for the experimental sessions.
During the two experimental sessions, which are expected to last six to
eight hours and take place two to three weeks apart, subjects will receive
psychotherapy, support, and guidance from Halpern and Naidoo, who will
videotape the sessions.
Each patient will have an hour-long psychotherapy session with the
psychiatrists the following morning to explore their experiences with MDMA.
Patients will also receive a copy of the videotaped session, which will, the
researchers hope, aid the patients in integrating the emotional content of the
experimental sessions, according to Halpern.
Patients will be assessed up to two months after the second experimental
Throughout the trial, Halpern will measure subjects' levels of anxiety,
quality of life, life function, and experience of pain.
Historically, anxiolytic and antidepressant medications have been given to
terminally ill patients who experience anxiety in relation to life-threatening
diseases, yet "there is a whole segment of the population who do not
respond to these medications or who refuse to take them," he pointed
Halpern acknowledged that though benzodiazepines can be helpful to those
with anxiety, they also have side effects such as unsteady gait and a sense of
being "foggy" or dazed that can be troubling to terminally ill
These individuals may not respond to antidepressants, he noted. "They
don't have a history of major depressive disorder, and their symptoms are
secondary" to their serious physical illnesses.
If the results of the pilot study are positive, Halpern said he would like
to replicate the study in a larger sample of patients.
He acknowledged the stigma surrounding drugs such as MDMA, which can be
harmful when taken for recreational use.
However, he noted, "the illicit use of a substance does not take away
its medicinal properties when used and dispensed under the good judgment of
physicians" with approval from agencies such as the FDA and the Drug
Halpern's research is being sponsored by the Multidisciplinary Association
for Psychedelic Studies, a nonprofit membership organization based in
More information about Halpern's study, "MDMA-Assisted Therapy
in People With Cancer-Related Anxiety," is posted online at<www.maps.org>.▪