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 :-)