Ayahuasca Research Project Update
The ayahuasca research effort we described in a previous
MAPS Bulletin article has been progressing slowly but surely. Obtaining ayahuasca was the first difficulty we encountered, but thanks to the help of several people we are indebted
to, we were kindly sent two 10 litre batches of ayahuasca by CEFLURIS in Brazil.
Our ayahuasca (Santo Daime) batches were freeze-dried and analyzed for beta-
carboline and DMT contents. The former were determined at our HPLC facilities, while the
latter was quantified by James C. Callaway in Finland. We would also like to express our
gratitude to him. Once this was done, freeze-dried ayahuasca was encapsulated in
gelatin capsules. The handling of the freeze-dried material was another unexpected
difficulty, as the material proved extremely hygroscopic even in an environment with
controlled humidity. This complicated the manipulation of the powder, which was done in
special plastic bags under dry nitrogen, and the storage of the prepared capsules, which
have since been kept in a freezer at -20 ºC under dry nitrogen and protected from
light.
Once we finally had the capsules ready, we began interviewing a
number of local (Barcelona) ayahuasca users. We selected a group of six healthy
male volunteers with previous experience with the tea, in order to conduct a pilot study.
Even though we had first considered using 0.5 and 0.8 mg DMT/kg body weight doses, we
decided to conduct a pilot study with three ayahuasca doses, containing respectively
0.5, 0.75 and 1.0 mg DMT/kg body weight. We administered the ayahuasca in a single-
blind dose-escalating design. That is, subjects were told they would receive the doses in a
randomized order. The investigator knew which doses were being given on each
experimental day. They actually received the placebo on the first session, the lower dose
on the second, the medium dose on the third and the higher dose on the fourth day of
participation. This was done for safety reasons, in order to control for possible adverse
reaction in the more stressing environment of a research lab. In this first pilot study the
following measures were conducted: subjective effects were recorded by means of visual
analogue scales (VAS), the Hallucinogen Rating Scale (HRS) and the Addiction Research
Center Inventory (ARCI), a standard questionnaire used in the clinical evaluation of
psychoactive drugs. Additionally, preliminary data on the prepulse inhibition of the
startle response and the P50 event related potential (both putative measures of
sensorimotor gating) were also obtained.
After completion of the pilot study we analyzed the subjective
reports and reecorded cardiovascular measures. We are presently preparing a paper
discussing the subjective effects reported by the subjects and the results of the
preliminary tolerability analyses (cardiovascular measures, results from the biochemical
and hematological determinations conducted after each experimental session). The pilot
study developed without major problems, but one subject decided to withdraw after the
second session, so we finished with only five volunteers. When the subjects were asked
which doses they believed they had been given on each session, one subject mistook the
lower dose with placebo. On the other hand, the higher dose was considered by all the
remaining five participants as eliciting excessively intense effects. We decided thus to
use a 0.6 DMT/kg body weight dose, that is a dose between the lower and medium doses of
the pilot study, as the lower dose in the larger double blind study. As the higher dose of
the final study, 0.85 mg DMT/kg body weight was chosen, between the medium and the
higher doses administered in the pilot study. So the final ayahuasca doses employed
were slightly different from those we reported in the MAPS article.
The experimental (clinical) part of the final double-blind trial is
almost completed now. Finding volunteers with experience in hallucinogen use and
meeting the inclusion criteria set in the study protocol proved difficult. As many as 90
subjects reached the psychiatric interview stage, but a large number were excluded later
for minor physical health problems or decided not to participate when they were told they
would have to spend ten hours in the lab on four different days, if they entered the study.
In the end, we have been able to include 18 volunteers as we had planned. As we described
in the MAPS Bulletin, the final double-blind trial included a large number of study
variables: the performance of 30 lead EEG recordings, blood sampling, urine collection,
etc. at different time points. We also incorporated the PPI and P50 measures mentioned
above, which were not ready at our lab until some time after we wrote the MAPS article.
This has all been a considerable amount of work, but it is now done and the prospect of
soon beginning to analyze the data gathered is again stimulating.
As a final comment, we have now started working on a SPECT protocol
in which ayahuasca will again be the center of our investigations. Before the
protocol is sent to the Ethics Committee, we will concentrate on analyzing and publishing
the data of the present study. This will doubtlessly facilitate the approval of a new
ayahuasca project by the authorities.
Jordi Riba and Manel J. Barbanoj, MD, Ph.D.
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