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Obtaining permission to conduct psychedelic research in the United States is no easy matter. Obtaining funding is even harder. Nevertheless, the field of psychedelic research in undergoing a mini-renaissance in the United States after a period of about twenty-five years in which virtually no research was conducted. Though relatively few studies are taking place, the United States is currently the world leader in psychedelic research (at least we can brag about something positive). Basic Phase 1 human safety studies are currently underway with MDMA, DMT, psilocybin, ibogaine and ketamine. In addition, the Food and Drug Administration (FDA) has approved Phase 2 efficacy studies with LSD which should start within the next six months. The FDA has also approved Phase 2 medical marijuana research but the Drug Enforcement Administration (DEA) and the National Institute on Drug Abuse (NIDA) are fighting this particular research project and it is not yet certain how this political battle will be resolved.
The field of psychedelic research is now poised on the threshold of a major breakthrough. Since the renaissance of psychedelic research began in 1990 with Dr. Rick Strassman's DMT research at the University of New Mexico, Albuquerque, the only studies that have been conducted have been basic Phase 1 safety studies. If all goes well, the transition into studying the potential therapeutic benefits of psychedelics will occur within the next six to nine months. If this transition can be managed successfully, the field of psychedelic research will be on a much more solid and politically secure footing.
The next frontier, after research into the therapeutic uses of psychedelics, is to obtain permission to use psychedelics as research tools to probe the functioning of the mind. As Dr. Stanislav Grof has noted, psychedelics can be as valuable to the study of the mind as the telescope is to astronomy and the microscope is to biology. In fact, several research teams ( at Yale University and U. of Washington) are currently using ketamine to help clarify the underlying biochemical mechanisms of schizophrenia. Since ketamine is already a prescription drug (it is approved by the FDA for use by anesthesiologists), this research has been relatively easy to initiate. Obtaining permission to use LSD, MDMA, psilocybin and other psychedelics for scientific research not directly linked to therapeutic uses is still on the horizon. MAPS is undertaking preliminary explorations toward locating funding and identifying research teams interested in conducting studies into the use of psychedelics in non-therapeutic scientific research. Research topics of greatest interest involve using high-tech brain scans to determine the physiological mechanisms of action of the various psychedelic drugs and using psychedelics to study the nature of the religious, mystical experience.
There are several regulatory agencies from which permission has to be obtained before a scientist can begin a psychedelic research project. The FDA has to approve of the basic scientific design of the study and has to be convinced that the risks to the subjects are outweighed by the scientific benefits. The DEA has to give the researchers permits to handle the psychedelic drugs and must be convinced that the researchers will use the drugs for the intended purpose. The NIDA controls access to legal supplies of marijuana but not the psychedelics and sometimes funds research with psychedelics.
In addition to the federal agencies, the State of California has established its own review board, absent-mindedly named the California Research Advisory Panel (CRAP!). The purpose of CRAP is to review all research conducted in California with Schedule 1 and 2 drugs (the most controlled drugs such as the psychedelics, marijuana,cocaine, morphine and methadone and other narcotics, etc). The State of California is the only state that has established its own regulatory oversight of research with controlled drugs. Fortunately, CRAP is composed mostly of scientists and has been quite helpful in practice.At present, MDMA research is taking place in California and marijuana research has been approved by CRAP.
In addition to government regulatory agencies, there is another level of review that psychedelic researchers must pass through before they can begin their studies. All human research experiments conducted in the United States (and in the rest of the world) must be approved by a special committee that reviews the research to make sure that the rights of the subjects in the experiment are protected. This level of oversight stems from the outrage of the world community after learning about the various experiments that the Nazis conducted on concentration camp victims. As a result, the post-war Helsinki Committee established certain rules to guide all human research, the most crucial rule being that patients must give their informed consent to the researcher before any research could begin. In the United States, the organizations that review research projects to make sure that they comply with the Helsinki guidelines are called Institutional Review Boards (IRB).
These IRBs are mostly local organizations established by hospitals and research centers. Since the concerns of the IRBs are humanitarian and scientific and not explicitly political, it has not been all that difficult to obtain IRB approval for psychedelic research.
As with all governmental agencies, the FDA makes decisions both on the basis of facts and on the basis of political pressure. Despite intriguing and promising findings from the psychedelic research studies conducted from the 1940's to the 1960's, the FDA of the 1970's and 1980's turned a deaf ear to scientists interested in conducting research into the therapeutic uses of psychedelics. Research studies in humans using psychedelics as tools to probe the mind were also generally prohibited unless the research was directed towards proving that psychedelic drugs were psychological harmful or physiologically toxic.
Despite FDA's several decades of hostility toward psychedelic research, some dedicated members of the scientific community never lost interest in conducting psychedelic research. From time to time, occasional protocols would be submitted to the FDA only to be rejected on one grounds or another.
Beginning in 1985, around the time that MDMA was made illegal, a series of well-designed applications to study MDMA were submitted to the FDA by five different research teams. All these applications were denied, supposedly because MDMA was too toxic to permit human research, even though tens of thousands of people were taking the drug illegally with virtually no resulting problems. What finally changed the attitude of the FDA was President George Bush's appointment of a new commissioner, Dr. David Kessler, in 1989. It would not be accurate to say that Dr. Kessler was a proponent of psychedelic research. Rather, Dr. Kessler was a proponent of science. In his view, psychedelic research should be evaluated on scientific and not political grounds. This subtle but profound shift in attitude at the FDA has made all the difference, especially since Dr. Kessler still directs the FDA under President Clinton. What matters now to the FDA is the scientific quality of the research protocols governing psychedelic research, not the conflict that might arise between the facts about psychedelic drugs discovered in scientific research and the fear-based propaganda about psychedelics that other government agencies spread in an effort to reduce drug use.
The mission of NIDA is to reduce drug use and drug abuse (which NIDA mostly considers to be the same thing). In furtherance of this mission, NIDA has consistently funded animal studies with psychedelics to determine their mechanisms of action and physiological and behavioral toxicity.
Unfortunately, the linkage between animal data and human data is not always clear. In the late 1980's, after about twenty years of animal studies that were not correlated with human data, the value of NIDA's animal research program was in some doubt. As a result, some NIDA-funded scientists and NIDA officials began to see a need for human studies with psychedelics aimed at exploring the physiological and psychological effects of a variety of psychedelic drugs.
Due to its mission, NIDA is not generally interested in the therapeutic uses of psychedelics. NIDA is, however, interested in studying the harms of psychedelics and their non-medical, "recreational abuse". The first psychedelic drug study funded by NIDA in the last several decades began in the late 1980's. It was a sociological study of MDMA users. The researchers who conducted this study (Dr. Marsha Rosenbaum was the principle investigator) interviewed MDMA users but did not actually administer MDMA to subjects. The study concluded that MDMA has a low potential for abuse, and was not publicized by NIDA. Dr. Jerry Beck, who worked on the MDMA study, has just received a new grant from NIDA to study the use of all psychedelics. This study is also a sociological study that does not involve any drug administration.
The second psychedelic research study funded by NIDA was a bit bolder in that it did involve the administration of a psychedelic drug, DMT, to human volunteers. This study began in 1990 and was conducted by Dr. Rick Strassman. Since DMT is the only known psychedelic that is endogenous in the human brain, this study was presented to NIDA as a method of gathering information about whether an imbalance of DMT might be linked to a mental illness of some sort such as schizophrenia. Dr. Strassman successfully managed to receive funding from NIDA. However, he obtained the DMT itself from Dr. David Nichols, an academic researcher who had obtained DEA permission to manufacture it for Dr. Strassman's study.
By 1994, Dr. Strassman had established an excellent track record with his research with DMT. He then submitted an application to NIDA for funding to conduct a safety and dose-response study of psilocybin. This request for funding was also successful. As with the DMT, Dr. Strassman obtained the psilocybin from Dr. Nichols.
NIDA is not uniformly willing to fund all psychedelic research projects. In 1984, Dr. Grob of Harbor-UCLA Medical Center submitted a funding request to NIDA for a safety study with MDMA but was denied, probably due to the more controversial nature of MDMA. Dr. Grob submitted another funding request to NIDA for a revised study on February 28,1995 and will learn by August, 1995 if his latest funding request is granted.
Another source of support within NIDA for psychedelic research was the creation of a new division specifically to develop novel treatments for drug abuse, the Medications Development Division (MDD). The MDD was initially not at all sympathetic to psychedelic research. What turned the tide was the very effective patient lobby for the use of ibogaine, an extract of the psychedelic root iboga from Western Africa. The patient lobby claimed that ibogaine had the ability to help addicts overcome their addiction after one powerful psychedelic experience, reminiscent of the studies from the 1960's and 1970's that demonstrated that LSD had a positive effect in some alcoholics. In the early 1990's, NIDA began funding animal studies with ibogaine which suggested that the reports of the addicts might indeed have some pharmacological basis. NIDA has spent in excess of $2 million on the animal studies but has yet to fund human studies with ibogaine. For the last several years, NIDA but has been developing an ibogaine research protocol for addicts. NIDA convened a panel of experts on March 9,1995 to review its protocol design and will decide in the next several months if it will go forward with funding human ibogaine studies. NIDA is being less than helpful with medical marijuana research. In early 1994, the FDA approved a research protocol to study the use of smoked marijuana to treat the AIDS Wasting Syndrome. Since the oral THC capsule is FDA-approved for use in the Wasting Syndrome and since many patients claim that smoked marijuana works better than the THC capsule, this is a solid protocol evaluating a realistic potential medical use of smoked marijuana. Nevertheless, NIDA tends to see this study as step towards the legalization of marijuana for recreational use. As a result, NIDA has been sitting on an application for a supply of marijuana for this research project since early August, 1994. Unfortunately, unlike the situation with DMT and psilocybin, NIDA is the only legal supplier of marijuana for research purposes (the DEA has blocked our attempt to import marijuana from the Netherlands for use in medical research). NIDA is institutionally opposed to medical marijuana research, in part because NIDA has invested a great deal of effort in drug abuse prevention educational materials that claim that marijuana is all bad and has no therapeutic uses. A rather large political campaign is being waged to pressure NIDA to supply the marijuana to the study. About a dozen Senators and Representatives have written to NIDA to express support for the project. A decision is expected soon about whether this study will be permitted or not.
Phase 1 research with MDMA, DMT, psilocybin, ketamine, ibogaine are all underway. It is likely that research with marijuana will continue to be blocked. In 1995, there is a very good chance that the field of psychedelic research will make the transition from Phase 1 safety studies to clinical research into the therapeutic uses of the various psychedelics in actual patient populations. There is a good possibility that research into the use of ibogaine to treat substance abuse will be funded by NIDA. However, there is very little chance that any government funding will be available for research into the use of LSD or ketamine to treat substance abuse, or for the use of MDMA, LSD, or psilocybin to treat AIDS or cancer patients. Such research will need to be funded by private individuals. If you would like to support this research, or just keep up to date with it, please consider becoming a member of MAPS at $50 per year or more. Membership benefits include four newsletters a year and the knowledge that you are taking an active role in fostering psychedelic research.Past issues of the MAPS newsletter are available for free or by e-mail retrieval by sending a message to Majordomo@server.blueline.com with
on one line in the body of the message and on the next, followed by on the last line. The subject line is irrelevant. The momentum in psychedelic research was built through the combined efforts of many dedicated individuals. Further progress can be made by adding your support to this effort. MAPS can be reached at 1801 Tippah Avenue, Charlotte, North Carolina, 28205, ph. 704 358-9830, fax 358-1650, st.maps@cybernetics.net