(No subject)

[Guest guest]

Dear Group,

 

It seems that a drug is good or bad depending on who is selling it to

you....................

 

 

According to news reports from the Wall Street Journal and the

Associated Press,

the Food and Drug Administration (FDA) has approved an application by

researchers affiliated with the Medical University of South Carolina

to conduct a

clinical trial using MDMA (Ecstasy) to treat post-traumatic stress

disorder (PTSD).

The university has not formally approved the clinical trial, however.

 

The approval of a trial using Ecstasy, a drug that has become widely

abused among

students and young adults, caught many in the addiction treatment

field by surprise.

Alan I. Leshner, Ph.D., director of the National Institute on Drug

Abuse (NIDA),

responded to the news by telling the Wall Street Journal, " I know of

no evidence in

the scientific literature that demonstrates the efficacy of Ecstasy

for any clinical

indication. We don't give drugs of abuse to naïve subjects except

under

extraordinary circumstances. "

 

NIDA teamed up in 1999 with the American Academy of Child and

Adolescent

Psychiatry (AACAP), Community Anti-Drug Coalitions of America (CADCA),

Join

Together and National Families in Action to spearhead a club drug

prevention effort,

of which Ecstasy was a major target (see ADAW, Dec. 13, 1999). The

multimedia

campaign includes a Web site -- www.clubdrugs.org -- and has

distributed postcards

in shopping malls throughout the country.

 

The clinical trial, if approved by the Medical University of South

Carolina's

institutional review board, would mark the first time the FDA has

sanctioned

Ecstasy to treat a psychiatric disorder. In a released statement, the

university stated,

" A research protocol involving the testing of the drug MDMA (Ecstasy)

on human

subjects has not come up for review by this board. Until such time

that the board

reviews and determines that the research meets ethical and legal

standards, the

protocol will not be tested on the Medical University of South

Carolina campus. "

 

Michael Mithoefer, M.D., upon university approval, will conduct the

research.

" Despite the serious problems that can occur with uncontrolled use,

there is good

evidence that MDMA can be used safely in a controlled clinical

setting, " said

Mithoefer. " The potential benefits from research that could lead to

better treatment

for patients suffering from chronic PTSD outweigh the minimal toxicity

potential

from therapeutic doses of MDMA. "

 

The clinical trial would be a double-blind, placebo-controlled study

designed to

investigate the safety and efficacy of two MDMA-assisted psychotherapy

sessions

conducted three to five weeks apart. Researchers will enroll 20

subjects who have

PTSD as a result of crime victimization, including childhood sexual or

physical

abuse. The MDMA-assisted therapy will be compared with a placebo.

 

The study is being funded by the Multidisciplinary Association for

Psychedelic

Drugs (MAPS), a group whose goal is to make certain psychedelic drugs

prescription medicine. According to MAPS, the effort to use MDMA in

psychotherapy research has been under way since the FDA designated

MDMA as

a Schedule 1 drug in 1985. Prior to that, MDMA was used by some as

part of

PTSD therapy.

 

However, recent studies have raised concerns about Ecstasy's impact on

the brain.

A study published in the October issue of the Archives of General

Psychiatry

linked use of the drug to impaired memory function (see ADAW, Oct.

22). Ecstasy

users showed brain neuron changes related to the neurotransmitter

serotonin.

 

Other researchers have theorized that Ecstasy causes dramatic

fluctuations in

serotonin levels. Some believe that long-term use can cause lasting

depression.

 

In addition, Ecstasy use rates among youths are decidedly on the rise.

The latest

Monitoring the Future survey found a sharp increase in use among 8th,

10 th and 12th

graders (see ADAW, Jan. 1).