From: [h--rr--s] at [bhc.com] (Bob Harris)
Newsgroups: alt.drugs
Subject: Maps newsletter pt 1
Date: Sun, 2 Jan 94 22:19:36 GMT

Year 1994 Vol. IV, No. 3

1801 Tippah Avenue
Charlotte, NC 28205
Phone (704) 358-9830
Fax (704) 358-1650
Internet:   RICKMAPS.aol.com

Phase 1 MDMA Research...
MDMA Neurotoxicity Update...
MDMA in the Treatment of 
Post Traumatic Stress Disorder..
Medical Marijuana Research...
Membership information.. 
Water Pipe Study...
Ibogaine Research..
Sylvia joins MAPS...
Swiss Academy of Medical 
Sciences LSD Conference...

MAPS has been experiencing growing pains since the last newsletter was mailed
to members. MAPS has been successful in enlarging its membership base, 
several  research projects that MAPS is coordinating are coming to fruition,
and the field of psychedelic research in general is experiencing a
renaissance.  The flow of mail, phone calls, and e-mail messages has
increased (MAPS now has an internet  address on America On Line: 
RICKMAPS.aol.com),  as has the number of requests from the media for
information (see article on drug trends in Newsweek, December 6, p. 62).
MAPS' expanding opportunities and
responsibilities have also coincided with a very personal and joyous but
time-consuming series of celebrations,  namely my marriage.  
   This MAPS newsletter is written almost entirely by myself, unlike the last
issue which was more like a journal.   MAPS has so many  projects underway
that I wanted to let you know about them in
 some detail.  I should have more time to put out a lengthier newsletter with
the next issue. 
Very fortunately, MAPS has recently obtained the part-time assistance of
Sylvia Thyssen, a bilingual University of North Carolina at Chapel Hill
liberal arts graduate ( see page 12). If contributions to MAPS are
sufficient,  it is our hope that Sylvia will be able to work full-time for
MAPS in the not too distant future.   
 MAPS' growing pains are primarily a result of the recent developments in
MDMA and marijuana research.  After eight years of effort, FDA-approved 
Phase 1 human studies with MDMA are commencing at UCLA's Harbor Hospital
under the direction of Dr.
Charles Grob (see page 2). MAPS recently donated $2,700 to pay  for
high-tech brain scans for two
of Dr. Grob's experimental  subjects.  Research into the use of MDMA in the
treatment of pain and distress in cancer patients will follow after the
Phase 1 study.
  During the last several months,  three additional MAPS-coordinated research
projects have cleared most of the hurdles required prior to actual
implementation.  
 Dr. Donald Abrams' marijuana project  exploring the use of smoked marijuana
in the treatment of the HIV-related wasting syndrome has been approved by the
FDA (see page 5). The MAPS-California NORML project to investigate the
effectiveness of water pipes in filtering marijuana smoke will begin in early
1994. The  necessary $28,800 has been obtained, due in part to the generous
gift of $18,000 from a MAPS member (who gave $14,000 and also bid $2,000 each
for the two original Doonesberry cartoon strips donated to MAPS by Garry
Trudeau (see page 10). An exciting new MDMA research project, not previously
discussed in any MAPS newsletter, will  explore the use of MDMA-assisted
psychotherapy in the treatment of post-traumatic stress related to war
trauma.  This study will take place at the Military Hospital in Managua,
Nicaragua. Permission for the study has been granted by the Nicaraguan
Minister of Health (see page 3).   
 After enormous and sustained effort by advocates, the FDA has approved Phase
1 human trials designed to explore the physiological and psychological
effects  of the African psychedelic root, ibogaine. Phase 2 trials examining
the use of ibogaine in the treatment of cocaine addiction will follow  (see
 page 4).
 Your previous support of MAPS has nurtured the infant field of psychedelic
research. Your continued support will help enable the field to continue its
long, slow walk toward scientific maturity and social sanction. Rick
Doblin, MAPS President.

We Begin! -
The First FDA-Approved
 Study of the Effects of MDMA on Human Volunteers

 All the necessary permissions, approvals, sign-offs, shipping forms, and
scientific protocols are in place for the first  ever FDA-approved human  re
search with  MDMA. Around New Years' Day, 1994,  Dr. Charles Grob's pharmacy
at Harbor UCLA Medical Center will receive a supply of legal MDMA , from Dr.
David Nichols of the Department of Medicinal Chemistry at Purdue University. 
Dr. Nichols, who under DEA license also manufactured Dr. Rick Strassm
an's DMT and psilocybin,  originally made MDMA for research purposes in 1985.
  At the time, we weren't sure if we would ever be able to administer the
MDMA to humans instead
of just to research
 animals.  Though it took eight long years  to reach this point, it was well
worth the effort.
 Dr. 
Grob's original FDA-approved protocol involved the administration of two
doses of MDMA and one dose of placebo to six people, along with a  limited
variety of physiological and psychological tests.  However, in the
intervening time between FDA-approval and all the other required approvals,
Dr. Grob developed a collaboration with  Russell Poland, Ph.D.,  a  fellow
UCLA faculty member who is an expert in the assessment of the effect of drugs
on brain neurochemistry.  As a consequence,  the pilot study has been sub
stantially expanded to clarify more exhaustively  MDMA's physiological
effects. MDMA pharmacokinetic studies will also be added to the study, as
will fenfluramine challenge tests designed to probe
 the function of the subjects' serotonin  system.  Since serotonin is
involved with the regulatio
n of sleep,  special Sleep EEG studies will be conducted in order to learn
more about MDMA's short and long-term effects on the serotonin system and its
functional correlates.  Subjects in the study will also receive high-tech
brain scans (Magnetic Resonance Imaging)  and computer-enhanced analysis of
brain wave patterns (SPECT). These tests will permit a more thorough evaluation
of
MDMA's long-term  and short-term structural and functional effects on the brain.
MAPS' 
donation of $2,700 towards the expenses of this study will cover the cost of
these scans for two subjects.
SEEKING GOVERNMENT FUNDING
 Drs. Grob and Poland are also interested in conducting a separate study
similar in design to
 Dr. George Ricaurte and Dr. Una McCann's multi-year investigation of the
physiological and psychological differences between a group of MDMA users and
a group of matched controls. Drs. Grob and Poland will thankfully substitute
high-tech brain scans for spinal taps. Due to the  substantially increased
complrexity and cost of Dr. Grob and Poland's  Phase 1 MDMA study, and also to
their plan to conduct another study involving matched controls,  they are
planning to apply to the National Institute on Drug Abuse (NIDA) for a grant
for their MDMA research.   The grant application is due February 1,1994 with
the awards being announced in the fall of 1994.  From now until February 1,
Drs. Grob and Poland will be testing several subjects so as to gather
preliminary pilot data to support their grant application.
  MAPS'  donation ($2,000 of which was raised from the conference
commemorating the 50th anniversary of LSD and the remaining $700 from
membership donations)  will be used to help gather pilot data for the NIDA
grant application.  In this way, MAPS is using its relatively limited
resources strategically,  allowing Drs. Grob and Poland to use a small
donation from MAPS  in ways which enhance their efforts to secure a large
grant from NIDA. This strategy  has worked well in the past when MAPS offered
some early assistance to Dr. Ricaurte so that he could  gather preliminary
MDMA neurotoxicity data from primates and MDMA users who volunteered for
spinal taps. With  the help of skilled researchers and a little luck, the
strategy has an excellent chance of working again.
 From February 1, 1994 until about the end of the year,  when NIDA is
supposed to decide whether or not to support their enlarged study, Drs. Grob
and Poland will proceed with their Phase 1 study as far as their  funds
allow. In other words,  donations are still needed to facilitate this
project.  (If interested in volunteering for the experiment, call Carla
Edwards at  Harbor-UCLA Medical Center in Torrence, California at 310
222-1663.  Subjects who live in Southern California are best because  the
study will require subjects to go to the laboratory from seven to ten
different days and/or nights.)  

MDMA CANCER STUDY
It is our hope that enough basic Phase 1 safety data will be gathered by the
fall of 1994 so that the FDA will permit Dr. Grob to initiate  the Phase 2
study of the efficacy of MDMA in the reduction of pain and distress in
terminal cancer patients.  This  MDMA study will focus on one of the most
important areas of research in modern medicine, namely the mind-body
connection.  Dr. Grob and co-researchers will seek to determine whether
MDMA-assisted psychotherapy and guided imagery can help patients reduce their
sensitivity to pain and lessen the number of deadening narcotic painkillers
they need,   stimulate their immune system to fight their cancer, and help
people deal more effectively with the emotions surrounding terminal illness.


MDMA Neurotoxicity Update -
New Data from Drs. Ricaurte and McCann to Consider

 The results of Dr. Ricaurte and Dr. McCann's multi-year study were first
presented at a neurosciences conference in mid-November,1993 and will be
reported on in more detail in the next issue of the MAPS newsletter. The
study found that the MDMA-experienced group (of which I was a member)  had on
average  30% lower levels of a serotonin  metabolite in their spinal fluid
than did the control group. Interestingly enough, the only functional and
behavioral differences between the MDMA group and 
the controls were that the MDMA users  "reported less impulsive and hostile
personality traits, and greater constraint and control". As Drs. Ricaurte
and McCann point
out, these differences are generally considered positive.  Furthermore, these
findings are perplexing in that the generally held view is that lower
serotonin levels lead to more hostile and impulsive behavior, not less.  As
with most MDMA neurotoxicity studies so far, this one raises more questions
than it resolves. More research is required to sort out the findings.  
  One difficulty in interpreting the results of  this  study is that
comparing people to matched controls is as much art as science.  People are
wonderfully unique, especially so when it comes to serotonin. Finding a
perfectly matched control is almost impossible since the normal level of
brain neurotransmitters varies enormously between individuals. Nevertheless,
comparing people who have used MDMA many times in the past to matched
controls who have not used MDMA does have some advantages over a controlled
study administering only a few doses of MDMA to its subjects. In a matched
control study, people who have used MDMA a substantial number of times can be
evaluated (Dr. Ricaurte's group averaged over 50), making any serotonin
changes caused by 
MDMA more likely to be noticed.  Data from both sorts of studies,  with
matched controls or  subjects as their own control,  will be needed to  
assess more fully MDMA's complex and fascinating
effects.
 NEUROTOXICITY POTENTIAL IS OPTIONAL 
  If someone were seriously concerned about neutralizing the possibility of
 serotonin changes, (though  I think the evidence doesn't justify the
effort),  animal research has shown that combining the prescription drug
Prozac with MDMA prevents neurotoxicity, even when Prozac is taken up to six
hours after the  MDMA.  This works because Prozac binds to the same serotonin
re-uptake sites which can be damaged by MDMA metabolites (though only when
MDMA is administered at doses higher than the standard therapeutic or
non-medical amount). The presence of Prozac at the re-uptake sites prevents
the neurotoxic MDMA metabolites from binding, eliminating its potential
effect on the re-uptake sites. An interesting paper by  Dr. McCann and Dr.
Ricaurte discusses the effects of the MDMA/Prozac combination (Journal of
Clinical Psychopharmacology, 13 (3):  pp. 214-217, 1993.)

The Nicaragua Project:
MDMA in
 the Treatment of Post-Traumatic Stress Disorder Related to War Trauma 
 
 I am especially proud to be able to announce a new MAPS project that has not
previously been mentioned in the MAPS newsletter.  This project will help
evaluate the safety and effectiveness of  MDMA-assisted psychotherapy in the
treatment of patients  suffering from  post-traumatic stress disorder (PTSD)
caused by  war-related trauma.  The project is being carried out under the
direction of Dr. Manuel Marin Madriz, chief psychiatrist at the Military
Hospital in Managua.  Permission for the study has been obtained from the
Nicaraguuan Minister of Health, as well as from all the relevant hospital
authorities. 
 PTSD is a profound psychological disorder.  Many therapists experienced with
the use of MDMA believe that it can be especially effective in treating PTSD,
even if patients have failed to find relief from more conventional therapies.
  MDMA-assisted psychotherapy purportedly has the potential to enable people
to process difficult emotions more effectively than they might otherwise do,
and  can help patients move beyond being tormented by their past trauma. 
Though LSD has very different subjective qualities than MDMA, Dutch psy
chiatrist Dr. Hans Bastiaans' use of LSD for decades  in the treatment of
concentration camp survivors is an inspiring example of the beneficial use of
psychedelics in the treatment of people with
 severe trauma. 
 When I founded MAPS in 1986, it was precisely to help facilitate research
projects like this one.  It gives me great satisfaction that  MAPS is helping
to coordinate the training of the Nicaraguan therapeutic team, the
development of the scientific protocol,  the implementation of the study, and
is also assuming primary responsibility for funding the project.  This
project is what MAPS' members make possible.
THE ADVISORY TEAM 
 MAPS  has obtained the help of a remarkable group of psychiatric and
psychotherapeutic advisors for this project.  Experts who will share their 
approach to the therapeutic use of MDMA with the Nicaraguan researchers 
include Dr. Claudio Naranjo, the pioneering psychiatrist  from Chile who
first researched the therapeutic uses of MDA and MMDA;  Richard Yensen,Ph.D.,
 a psychedelic researcher whose dissertation was on the therapeutic use of
MDA ( and who also speaks Spanish);  and Dr. George Greer, author of a paper
on his therapeutic use of MDMA in 28 patien
ts before MDMA was placed in Schedule 1.  
 MAPS is also assembling an outstanding team of experts in the study of
post-traumatic stress who will help in the design of the study. MAPS has been
very fortunate to obtain the help of Sylvia Garma, Ph.D., who works at the
San Francisco VA Medical Center. She  is originally from Argentina and was
recently part of a State Department -coordinated visit to El Salvador
designed to assist the Salvadoran Health Authorities in  studying and
improving their treatments for post-traumatic stress. MAPS is also seeking to
obtain the assistance of one of the foremost academic experts on PTSD who
previously  studied under Dr. Hans Bastiaans, as well as a psychiatrist who
speciarlizes in treating PTSD patients.
  The next issue of the MAPS newsletter will report more fully on this
project.  It is possible that some of MAPS' therapeutic experts will visit
Nicaragua in the February or March to begin sharing their expertise with the
Nicaraguan researchers. The study should take about a year or so to conduct,
and will cost about $30,000. Contributions earmarked for this project are
most welcome.


FDA Approves Human Studies with Ibogaine    
     The first FDA-approved studies into  the physiological and psychological
effects of ibogaine in humans will take place at the University of Miami
under the direction of Dr. Juan Sanchez-Ramos and  Deborah Mash, Ph.D. The
ibogaine study is intended primarily to gather data about safety, leaving
studies of efficacy for the next stage of research (assuming the drug is
considered safe enough for
further trials).
 
 These trials are designed as classic dose-response studies in which the
effects of very small doses of a drug are thoroughly monitored before
increasingly larger doses are tested. Generally, the doses ra
nge from "too little " to "too much".  Dose levels often include placebo, 
below any noticeable threshold, barely noticeable,  less than standard, 
average, large, and somewhat more than is comfortable. This study design  is
basically the same as that used by Dr. Rick Strassman in his research wi
th DMT, and that he will soon use in his upcoming studies of psilocybin.  Dr.
Charles Grob's Phase 1 MDMA protocol is also a dose-response study.  Even the
medical marijuana study may also be conducted with this design.  
 After the Phase 1 trials with ibogaine are complete, perhaps a year or so
after they begin,  Phase 2 trials will start to explore the use of ibogaine 
in the treatment of cocaine addiction.   MAPS made a small donation of $1,000
to support Drs. 
Sanchez-Ramos and Mash in their efforts to secure FDA-approval for the
ibogaine protocol.  It was a pleasure to direct some of MAPS' limited
resources to the ibogaine project .The study of the use of
psychedelics in the treatment of substance abuse is one of the most powerful
ways of contributing to a cultural shift away from demonizing drug addicts, 
and psychedelic drugs. Perhaps in time we will see a  popular recognition
that both drug addicts and psychedelic drugs  may  yet have positive
contributions to make to society when given the option of  supportive
cultural contexts.  

Swiss Academy of Medical Sciences Conference 
Commemorates the 50th Anniversary of 
Dr. Albert Hofmann's Discovery of LSD


On  October 22 and 23, 1993,  the Swiss Academy of Medical Sciences held its
LSD conference in Lugano -Agno, Switzerland amidst mountain lakes near the
Italian border.  By the end of the conference, I felt that the consensus of
the participants was that LSD should indeed be the subject of renewed
scientific inquiry.  This conclusion seemed to be echoed by all concerned
including experts in the treatment of drug abuse,  therapists, brain
neurochemists,  and even government regulators from several countries. While
the renewal of psychedelic research  is still in its infancy,   the Swiss
Academy of Medical Sciences conference made an important contribution toward
strengthening the scientific arguments and political consensus for  its
continued growth.  Perhaps Albert Hofmann's problem child, like so many of us
whose path
to adulthood was turbulent and troubled, may yet grow into a responsible
citizen. Much hangs
in the balance.
  The next issue of the MAPS newsletter will include a fuller discussion of
the conference. For now, here are some photographs to enjoy that offer a
glimpse into the mood of the gathering.

NOW THERE ARE TWO
SYLVIA THYSSEN -  MAPS' NEW STAFF MEMBER

Dear MAPS Members;

"Who is this person who has begun 
to answer our MAPS mail?" you ask.  For years, my career passion has been
museum studies, though now, I'm not so sure, and I'm exploring other
interests.  Upon graduation, I was
far from committing to a graduate program, so fortune returned me to my
hometown of Charlotte, where I met Rick.  Though what I first found
compelling about MAPS was the full 19-syllable name, what has kept me
committed is its multidisciplinary imperative, weaving together the varied
threads of thought and deed that cross paths with the MAPS office.  This
approach can only enhance research projects, heal minds and bodies, and
inspire us to understand more deeply our right to joy and freedom.  Ignore
the interplay of culture, medicine, and politics, and you're missing the point.   
This is why I am here!  I look forward to working with you.
   

Sylvia Thyssen

Bob Harris
8 :-)