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maps announcements & updates - January 2000
see also MAPS News Page
Need help with last patients
The historic study of the Short Term Effects of Cannabinoids in HIV Infection is looking
for the final 15
participants to complete the trial.
The goal is to finish enrollment in early 2000, hopefully by February, according to Donald
I. Abrams, M.D.,
Principal Investigator and Professor of Clinical Medicine at the University of California
San Francisco. The NIDA
funded trial is investigating the interaction of cannabinoids smoked or oral with HIV
protease inhibitor
drugs.
Subjects must be HIV positive with a stable viral load on a protease inhibitor containing
antiviral regimen. They
must have smoked marijuana in the past, but CANNOT have smoked within 30 days prior to
enrollment.
Subjects spend 25 days in the inpatient General Clinical Research Center at San Francisco
General Hospital.
They are randomly assigned after the first four days to either smoked marijuana, Marinol
or Marinol placebo.
The study agent is administered three times daily before meals for the next 21 days. Two
outpatient follow-up
visits are also scheduled. Particiapnts receive $1000 for completing the trial.
Of the 64 participants needed to complete the trial, 46 have been enrolled. The study is
particularly seeking
individuals who are taking indinavir (Crixivan) as their protease inhibitor. Women are
also being actively
sought. Participants cannot be smoking cigarettes, using methadone or any other Schedule
1 drugs.
If you know of someone who may be eligible and would like more information, please
contact the study
coordinator at 415-502-5705 for more information.
New FDA-approved psilocybin research needs donations
The first FDA-approved study in more than 20 years to examine the use of
psilocybin in a patient population is close to being initiated. The principal
investigators, Dr. Pedro Delgado and Dr. Francisco Moreno, University of
Arizona, plan to study the use of psilocybin in 10 patients suffering from
obsessive-compulsive disorder (OCD). They want to determine if they can
replicate in a clinical study several published case reports of patients whose
OCD symptoms were reduced after self-experimentation with psilocybin
mushrooms.
Read most current update
Introduction to a new psilocybin study
Thomas Heinz, MD
Co-investigators: Michael Schlichting, MD
and Michael Szukaj, MD
Since the 1980s scientists have become intensly re-engaged in researching the
basic
questions of efficacy, side-effects and toxicity (i.e. in Europe: Gouzoulis,
Hermle, Kovar, Vollenweider). Several projects have also begun or are
planned on how psychedelics can be used as adjuncts to psychotherapy. A new
german study with psilocybin is planned for 2000. The influence of synthetic
psilocybin (0,2 mg/kg bodyweight) on twenty-four physician volunteers will
be explored using psychometric and other tests under special set and setting
conditions. Ultimately, the objective of the research team is to explore the
utility of psilocybin as an adjunct to psychotherapy and for the self-
exploration and training of mental health professionals.
Hanscarl Leuner, the
famous German psychiatrist, psychotherapist and former director of the
European College for the Study of Consciousness (ECSC) researched psycholytic
psychotherapy in the 1960s and 70s. After his official permission to use
psychedelics as adjuncts to psychotherapy expired, he tried persistently to re-
open the doors for research projects on psychedelics until his death
in 1996. The roots of our project reach back to this effort; Leuner was the one
who called us together in 1995. In this pilot study we have decided to work
exclusively with healthy physicians, because, in
Germany, it is much easier to get official permission to start research projects
with psychedelic substances on human beings when the subjects are medical
professionals. These substances are strictly
prohibited in Germany. Psychopathological,
psychodynamic, pharmacokinetic and metabolic-toxicological examinations
will be conducted. We want to make a contribution to the research on the
paradigm of model-psychosis and to the biological and psychological research
on substance-related
dependency. In recent years the use of psychedelics in Europe and other
industrialized countries has increased. Thus, the influence of special set and
setting patterns on psychiatric and psychological aspects, on affectivity and
the motivation for using/abusing psychedelics are other spheres of interest.
The research on the individual motivation for the consumption of
psychedelics is of great scientific and public interest for public health and
drug abuse prevention strategies. Psilocybin is not a so-called "designer drug,"
but looking in at its effects, it is comparable. The simultaneous consumption of
different psychoactive substances may occur because the motivation to use
each drug may be similar in some aspects. The effects of psilocybin on the
human body and mind are well known and it seems to be a very safe substance
to study when investigating motivations for using psychoactive substances.
Conclusion:
In our viewpoint our project is a continuation of the research of Gouzoulis,
Hermle, Kovar, Leuner, Spitzer and others. We are honored by the
participation of our board of advisors: Prof. Dittrich, Dr. Hermle, Prof. Kovar
and Prof. Scharfetter. It is encouraging to see the resumption of the
impressive work of Stan Grof and others, who assisted "the human encounter
with death" with psychedelics in the past. Looking at the Internet it seems as if
there is a psychedelic research revival all over the world. The short acting
designer psychedelics (for example CZ-74 and LE-25) are especially
interesting, because of their ability to provide the positive aspects of
psychedelic expriences with minimal negative side effects. I hope that we will
be able to explore other new short acting-psychedelics in the following years
that could be useful as adjuncts to psychotherapy.
Contact: t.heinz.oberbergkliniken@t-online.de
Update: Salvia Divinorum Experiment
IN THE DOSE establishment phase of this study we have tested subjects on 1/2 gram, 1.0
gram, 1.5 grams
and 2.0 grams of dried and crumbled Salvia divinorum leaves. We had a hard time coming
up with a
placebo. Dried comfrey leaves are a very close duplicate, but they lack the bitterness of
Salvia. We had a
breakthrough in July when we found that if you wash dried and crumbled Salvia leaves in
two changes of
water - 2 full glasses of water per gram - the bitterness of it is gone. The active ingredient
Salvinorin-A is
insoluble in water. When treated in this way you cannot tell Salvia divinorum from
comfrey leaves prepared
in the same way.
Almost everyone liked the 1.0 gram level for meditation. The half-gram dose was rarely
detected by anyone.
The 2.0 gram dose was too strong for meditation. Effects from the dried Salvia leaves
soaked and washed in
water and then placed under the tongue were as follows. The actual technique is to chew
the leaves every five
minutes or so and return them to under the tongue.
0.5 grams... half of the subjects noticed a slight effect... a clearer than normal mind that is
free from
distractions. The other half noticed nothing at all.
1.0 grams... everyone noticed it when they were in a quiet room with no distractions. Mind
is clear and
meditation is unusually easy with few distracting thoughts. This dose was only detected
by anyone when they
were trying to meditate. The effect made it easier tc oncentrate without thoughts... a
definite plus for
meditation. If they, however, listened to music or did some activity they could not notice
any effect at all.
1.5 grams... half of subjects notice a trance like state beginning to happen. Effect is slight
but it inhibits
meditation for some.
2.0 grams produced a slightly trance like effect for some people with time distortion.
Generally people found
that level too strong for meditation. The effect was enjoyable however... a bit dream like
and time seemed to
slow down.
So those are the casual results from the dose establishment phase of the study. The next
step will be the
double blind study.
Ian Soutar
soutar@horizon.bc.ca
Read most recent update
New ketamine study published
Anesthesiology 1998 Jan;88(1):82-8
Psychedelic effects of ketamine in healthy volunteers: relationship to steady-state plasma
concentrations.
Bowdle TA, Radant AD, Cowley DS, Kharasch ED, Strassman RJ, Roy-Byrne PP
Department of Psychiatry, Harborview Medical Center, University of Washington, Seattle
98195, USA. Contact:
bowdle@u.washington.edu
Background: Ketamine has been associated with a unique spectrum of subjective
"psychedelic"
effects in patients emerging from anesthesia. This study quantified these effects of
ketamine and related them to
steady-state plasma concentrations.
Methods: Ketamine or saline was administered in a single-blinded crossover
protocol to 10
psychiatrically healthy volunteers using computer-assisted continuous infusion. A
stepwise series of target
plasma concentrations, 0, 50, 100, 150, and 200 ng/ml were maintained for 30 min each.
After 20 min at
each step, the volunteers completed a visual analog (VAS) rating of 13 symptom scales.
Peripheral venous
plasma ketamine concentrations were determined after 28 min at each step. One hour after
discontinuation of
the infusion, a psychological inventory, the hallucinogen rating scale, was completed.
Results: The relation of mean ketamine plasma concentrations to the target concentrations
was highly linear,
with a correlation coefficient of R = 0.997 (P = 0.0027). Ketamine produced dose-related
psychedelic effects.
The relation between steady-state ketamine plasma concentration and VAS scores was
highly linear for all VAS
items, with linear regression coefficients ranging from R = 0.93 to 0.99 (P < 0.024 to P <
0.0005).
Hallucinogen rating scale scores were similar to those found in a previous study with
psychedelic doses of
N,N-dimethyltryptamine, an illicit LSD-25-like drug.
Conclusions: Subanes-thetic doses of ketamine produce psychedelic effects in
healthy volunteers.
The relation between steady-state venous plasma ketamine concentrations and effects is
highly linear between
50 and 200 ng/ml.
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