The Struggle To Resume Ketamine Psychotherapy Studies in St. Petersburg
Evgeny Krupitsky, M.D. Ph.D. (kru@ek3506.spb.edu)
Chief of the Laboratoray of Clinical Psychopharmacology of Addictive States
St. Petersburg State Medical University, Russia
In April 2002, the studies of ketamine-assisted psychotherapy we
had been conducting since 1985 were halted, for two reasons. The first
reason was that the room where we kept the ketamine did not meet new
regulations for the storage of scheduled drugs (These include two iron
doors with two locks each, brick or concrete walls, concrete floor, a special alarm system, etc.).
More seriously, several months earlier, ketamine was moved from Schedule III into Schedule II.
This was part of Russia's own "War on Drugs," and was probably related to the increased prevalence
of ketamine abuse among youth. The rescheduling is an important distinction, since under
the recently accepted Russian federal "Law on Narcotics," it is forbidden to use Schedule II drugs
to treat addictions. That law was mainly aimed against substitution therapy for heroin addiction
(I should probably mention here that both methadone and buprenorphine maintenance have
always been prohibited in Russia). However, with the reclassification of ketamine into Schedule II
(where it joins methadone, buprenorphine, and some other drugs of addiction), this law turned
out to target ketamine psychotherapy as well.
Since our ketamine studies have been on hold, we have taken active steps to obtain permission
to continue our work. First of all, our hospital built a new room for ketamine storage, meeting
all requirements of the new regulations (the cost of the renovation was approximately $2,000).
The hospital then received an official license for keeping ketamine in that room from the local
authorities of the Ministry of the Interior.
We also initiated paperwork to obtain a permit from the Ministry of Health Care. First of all,
we submitted a set of documents to the Control Committee on Narcotics at the Ministry of Health
Care, which usually gives permission for any work with controlled substances. In several months,
we received a reply saying that for this sort of permit, we should apply to the Ministry of Health
Care's Pharmacological Committee (Russian analogue of US FDA), which issues permission for
clinical trials.
"In one year, we turned out at the
same place where we started."
We submitted a package of the documents to the Pharmacological Committee, and
in another several months received an answer. They cannot issue a permit, because under the new
narcotics law, ketamine cannot be officially registered for treatment of addictions, and they are
give permission only for the clinical trials of medicines that will be registered in Russia (preregistration
trials). When we asked where we should seek permission to do scientific studies
without the intent of registering ketamine for a new indication (e.g. for heroin addiction), they
recommended that we apply to the Scientific Department of the Ministry of Health.
We then submitted a package of documents to the Scientific Department, and received an
answer stating that it is not possible to
include this study in the Federal Research
Program without having it first approved
by the Control Committee on Narcotics at
the Ministry of Health Care.
Thus, the circle was completed. In one year,
we turned out at the same place where we
started.
"We would treat secondary
psychiatric diagnosis in
heroin addicts, which is not
forbidden - the law prohibits
using Schedule II drugs to
treat addictions, but not
addicts."
We later re-submitted our documents to the
Control Committee on Narcotics at the Ministry
of Health Care. As expected, we were denied a
permit under the new federal narcotics law. This
means that our multiple vs. single ketamine psychotherapy
(KPT) session study in heroin addicts
is now completed. I am completing statistical
analysis for 59 randomized patients, and
will draft a paper within a few months.
I do think we might have two possibilities
for the future: (1) We could apply for permission
to do ketamine studies in alcoholics, or (2)
We could ask for permission to treat PTSD or
personality disorders in heroin addicts with dual
diagnosis. In that case, we would treat secondary
psychiatric diagnosis in heroin addicts, which
is not forbidden - the law prohibits using Schedule
II drugs to treat addictions, but not addicts.
For now, we wait for the response from the Control
Committee on Narcotics at the Ministry of
Health Care, and if it is negative, we will initiate
a new round of paperwork to get permission
for alcoholics or dual diagnosis patients.
This will take months, or maybe even years, since
there is a strong prejudice against ketamine psychotherapy
among conservative Moscow authorities.
However, we still hope that at the end of
this long road, we will start doing ketamine studies
again!
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