ECSTASY DRUG EXPERIMENTS PLANNED

Harvard Scientists Are Looking For Way To Alleviate Anxiety Of Dying Patients

What Is Ecstasy

It's the common name for MDMA, which is short for
3,4-methylenedioxymethamphetamine. MDMA works by releasing large amounts of
the brain chemical serotonin, which helps regulate mood, sleep and appetite.

Numerous human and animal studies have shown heavy MDMA use can cause
neurological and behavioral problems, though the exact nature and
persistence of the damage is difficult to gauge.

BELMONT, Mass. -- Harvard researchers are preparing, for the first time in
30 years, to conduct human experiments using a psychedelic drug -- ecstasy
- -- in a study that would seek to harness the drug's mind-altering effects
to help ease the crushing psychic burdens faced by dying cancer patients.

In the experiment, 12 terminal cancer patients would be given MDMA, the
active ingredient in ecstasy, to determine whether the drug helps alleviate
their anxiety.

Harvard scientists said that if the results are positive, they will push
forward with large-scale tests that could make end-of-life ecstasy
treatments generally available to terminally ill patients.

The experiment seeks to establish a medical use for a drug whose abuse has
been on the rise among some young people, who use it recreationally for its
euphoric effects.

A small but growing group of scientists contends the drug, administered in
a controlled medical setting, can improve mental and emotional health.
Critics, including some in the Bush administration, said the experiment
might destigmatize a dangerous substance.

Complicating matters, the $250,000 experiment will be bankrolled by the
Multidisciplinary Association for Psychedelic Studies, a nonprofit that
advocates legalizing psychedelic drugs.

The group, run by drug-legalization activist Rick Doblin, has ambitions to
one day establish a nationwide chain of psychedelic therapy clinics that
would dispense LSD, marijuana and ecstasy to people with emotional problems.

Despite the potential for controversy, the Harvard scientists are committed
to the experiment.

"There's enough evidence for possible therapeutic benefits that it
outweighed the risk," said Dr. Bruce Cohen, president of Harvard-affiliated
McLean Hospital in Belmont, where the experiment will be conducted. "If the
evidence suggests this has value, then a more elaborate study will be done."

The trial would use a controversial drug to treat patients some believe to
be ill-served by the medical system.

To qualify for the experiment, a cancer patient must have a prognosis of
less than one year to live. These patients, said the Lahey Clinic's Dr.
Todd Shuster, often suffer from deep anxieties that can be eased only by
taking daily doses of sedatives that render them disconnected from reality.

"We're trying to avoid sedating people, to allow them to maintain a good
quality of life so they can enjoy the time they have with family and
friends," said Shuster, who will select the patients for the experiment.

Typically, dying patients are given such drugs as Valium, which can cloud
their minds, or antipsychotics that leave them edgy. Cancer specialists
said patients in any of these states have a difficult time resolving family
issues, arranging financial matters, or approaching death with a sense of
peace and understanding.

"Any kind of new tools that we could have would probably be worth looking
at," said Dr. John Peteet, clinical director of the psycho-social oncology
program at the Dana-Farber Cancer Institute. He is not involved in the
experiment but called it "novel."

APPROVALS, CONCERNS

Ethics boards at McLean and at the Lahey Clinic, which will provide the
patients, have approved the experiment, as has the U.S. Food and Drug
Administration. The Drug Enforcement Administration still must approve the
experiment, and Harvard officials said they expected to hear from the
agency within weeks.

David Murray, a policy analyst with the White House Office of National Drug
Control Policy, said he was worried the Harvard experiment could
destigmatize ecstasy while failing to find any clear-cut medical use for
the drug.

"It is my impression that we are unlikely to learn anything of medical
value," because of the trials' small size, he said. "I'm surprised ... this
has passed muster."

Murray listed a number of studies indicating ecstasy abusers suffer
neurological problems. "The record on the risks of this drug is unambiguous."

But McLean's Dr. John Halpern, who will run the trial, said the Harvard
experiment will be safe: "The studies didn't raise any concerns about
giving MDMA a few times in a medical setting."

Ecstasy use has exploded in some subcultures, particularly in so-called
rave circles, where young people high on the drug dance euphorically for hours.

"People describe feeling empathy, decreased stress, increased confidence,"
Halpern said.

THE EXPERIMENT

In the Harvard experiment, eight patients will get a dose of MDMA that
researchers believe will elevate their mood; four patients will receive a
lower dose.

The dosing, under the supervision of five doctors, will occur immediately
before an intense eight-hour therapy session. The drug alone, Halpern said,
would provide only a temporary respite, but when combined with therapy, it
could help permanently resolve underlying psychological problems. He said
these problems often involve uncertainty about loved ones' futures,
unresolved family conflicts, finances, and fear of death.

"The ecstasy is not in the drug, it's in the person. People need to embrace
themselves and talk about what's important to them."

Each patient will have two intensive therapy sessions, preceded by MDMA,
two weeks apart. They also will get six shorter sessions that wont' involve
the drug. Halpern's team will use standardized anxiety tests to see whether
the MDMA therapy helps and will compare the lower- and higher-dose patients
to help gauge the most effective MDMA dose.

THE GHOST OF LEARY

Dr. Timothy Leary, a Harvard professor in the 1960s, infamously
experimented with psychedelic drugs at Harvard until he was ousted in 1963,
the last time a Harvard researcher there worked with psychedelic drugs.

Leary conducted medical experiments using students, though his aim was to
determine whether psychedelic drugs could enhance human cognition rather
than alleviate suffering.