Another Green Light from the FDA! – MAPS News: October 2009
Dear MAPS Supporters and Friends,
We just learned some incredibly exciting news from the FDA. We have been granted permission to proceed with our MDMA/PTSD therapist training protocol! This means we will be able to legally administer MDMA to the therapists we will be training to conduct our Phase 2 and Phase 3 MDMA/PTSD studies. Through collaboration with the FDA, we designed a Phase 1 protocol that assesses the psychological effects of MDMA on healthy subjects, while meeting our goals of allowing our therapists to be able to experience the subjective effects of MDMA-therapy.
We have several ways for supporters like you to help raise funds for our mission. We are accepting donated items for our online holiday auction next month. On October 24th in Vancouver we are having a benefit dinner for our new Vancouver MDMA/PTSD study. In a few weeks MAPS members can host house parties to watch the National Geographic special, “Inside LSD,” and encourage their friends to become MAPS members.
Perhaps the easiest way to help MAPS from where you are sitting right now is to help fund our studies by using Goodsearch every time you search the Internet or shop online. Goodsearch is a search engine that donates 50% of its revenues to charities designated by its users. Plus we have a unique gift of the month for current members who donate $25 or more and for new members who donate $50 or more.
Volunteers are asked to sign up for our 10-10-10 plan get 10 of your friends to buy $10 memberships in 10 days and get rewarded with MAPS books, visionary art, and free registration to our “Psychedelic Science in the 21st Century” conference next April. We have new information about the conference below, including registration and hotel information and pricing.
Randolph Hencken, M.A.
Director of Marketing and Communication
Heres a sample of what is happening this month at MAPS:
- Last Month to Give Gifts to MAPS for Holiday Auction
- Vancouver Benefit Dinner for MDMA Research on October 24
- Rene and Susan Ruiz Donate $5000 in Matching Funds and Renew their Challenge Grant for another $5000!
- Get involved with MAPS 10-10-10 Challenge to Increase Membership
- “Inside LSD” Broadcast on National Geographic Explorer 11/3/09 Host a Viewing Party to Build Community and Increase MAPS Membership With Our Matching Grant Program!
- Easy Way to Support MAPS: Use GoodSearch for Online Shopping and Searching
- Rick Doblins Parents Donate $4000 to MAPS
- Gift of the Month: Flower Essence of Banisteriopsis Caapi
- Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA
- Several MDMA/PTSD Protocol Documents Revised4
- MAPS Next U.S. MDMA/PTSD Study in Veterans Protocol Development Proceeds
- Progress Report: Jordan and Israel MDMA/PTSD Research
- MAPS Made Much Media this Month
- Clinical Psychology Review Article, “Emerging Treatments for PTSD,” Discusses MDMA Therapy
- Doblin and Hencken to Present at Canadian Students for Sensible Drug Policy Conference
- MAPS Executive Director Rick Doblin, Ph.D. on Evolver Teleseminar, Last Week of October
- MAPS Members Seek Others to Create Retirement Community
- MAPS co-hosting 2009 Drug Policy Alliance (DPA) International Drug Policy Reform Conference
- Psychedelic Enthusiasts Gathered at Horizons Conference
- Psychedelic Science in 21st Century: Registration and Lodging
- Pre- and Post- Conference Workshops Planned for MAPS “Psychedelic Science in the 21st Century” Conference
- Psychedelic Science in the 21st Century: Call for Proposals
Psychedelic Science in the 21st Century Conference:
* * * Dues-paying MAPS members are empowering staff, scientists, and volunteers to carry out pioneering research and educational projects. To donate, learn about the benefits of MAPS membership, or purchase books, clothes, art, and other merchandise, visit: store.maps.org * * *
Please help us raise funds for our mission by donating something of value for our online holiday auction? We will gladly accept any item you have that you can imagine someone else purchasing. All gifts are generous gifts whether the item is worth $10 or $10,000 we will make the best use of your gift.
MAPS is partnering with Tides Canada to act as the fiscal sponsor for MAPS to accept donations from Canadian citizens and provide them with tax receipts.
On October 1, MAPS had its first ever telethon. Five volunteers came to MAPS headquarters in Santa Cruz to call MAPS supporters in Canada and Washington State to ask for financial support for the new Canadian study. Maybe you were one of the lucky people called by our enthusiastic volunteers. We offer a giant and warm “Thank You!” to the volunteers and to those who pledged additional support. If you would like to volunteer with MAPS please complete the form on our volunteer page.
On September 21, MAPS received a donation of $5000 from long-time supporters Rene and Susan Ruiz, fulfilling their pledge for a matching grant for 200 new members. For each new members first gift of at least $10, Rene and Susan have added an additional $25 to cover the amount of a basic MAPS membership. Many of these new members joined MAPS at events where MAPS staff and volunteers have tabled.
These past few months have been especially fruitful for our membership campaigns. Over the past four months we have more than tripled the number of new donors we get per month compared to the first half of this year (doubled compared to the same months of last year)! We attribute these outstanding numbers to all of the work of the tabling volunteers, the new website, special promotions in these email newsletters, fundraising appeals in our Bulletins, the brunch we hosted in Santa Cruz, web 2.0 outreach, and of course the generosity of Rene and Susan.
Rene and Susan Ruiz have offered MAPS another challenge grant of an additional $5000 in matching funds. Our goal of this special challenge is to obtain 200 new members by the end of the year.
Help us recruit new members and earn the second challenge grant from Rene and Susan Ruiz by becoming a MAPS volunteer on our 10-10-10 Challenge. The 10-10-10 Challenge rewards members who recruit 10 people over 10 days to become members. MAPS basic membership is normally $35 a year. Rene and Susans grant is covering the other $25. In addition to the satisfaction of recruiting new members, you have the opportunity to win MAPS books, visionary art, and free registration to our upcoming conference, “Psychedelic Science in the 21st Century”, (April 15-18, 2010, in San Jose, CA). To learn more about the 10-10-10 Challenge, fill out the volunteer form on our volunteer page and Brian will contact you via email.
On Tuesday, November 3 at 10:00 PM EDT/7:00 PM PDT, National Geographics “Explorer” program will be featuring a documentary about the renewal of psychedelic research, focusing on LSD and psilocybin. The episode “Inside LSD” interviews several of MAPS colleagues and friends including pioneering psilocybin researcher Charles Grob, M.D. and one of the cancer patients in his psilocybin /cancer anxiety study
Here is how the show is described by National Geographic:
“Now science is taking a fresh look at LSD, including the first human trials in over 35 years. Using enhanced brain imaging, non-hallucinogenic versions of the drug and information from an underground network of test subjects who suffer from an agonizing condition for which there is no cure, researchers are finding that this trippy drug could become the pharmaceutical of the future. Can it enhance our brain power, expand our creativity and cure disease? To find out, Explorer puts LSD under the microscope.” [read more].
Help out MAPS this holiday season and all year round by utilizing GoodSearch for your entire Internet searching needs. Just select MAPS as the cause you choose to benefit and every time you search the web through the GoodSearch site a small donation is made to MAPS. This holiday season do your online shopping using the GoodShop query, with MAPS as your selected cause, and a portion of the sales will be donated to MAPS. Installing the GoodSearch toolbar in your web browser is the easiest way to be sure that your search queries and purchases will benefit MAPS every time you search the internet.
Morton and Arline Doblin, parents of MAPS Executive Director Rick Doblin, Ph.D. donated $4000 to MAPS this month, delighting and surprising Rick. This is further evidence that, eventually, even ones own parents can become comfortable with and supportive of their childs interest in the healing properties of psychedelics and medical marijuana. “MAPS is truly a family values organization!” said Rick.
This month’s Gift of the Month is donated to us by Flower Drop Faeries, a San Franciscan company that makes a wide range of different flower essences, floral waters and mists. Flower essences are not scented and are not aromatherapy products or essential oils. There are no “active ingredients” likein herbal or pharmaceutical products, and they do not contain any physical traces of the actual flower or plant. Flower Drop Faeries uses a 50/50 solution of brandy and water, which is the traditional method to preserve flower essences.
This “Ayahuasca Essence” tincture comes in 1 oz bottles. The solution was made exclusively from Banisteriopsis caapi, a bark that in actual ayahuasca is mixed with psychotria viridis (the DMT containing leaves). This gift is available to any current member who donates $25 or more and to any new member who donates $50 or more. Supplies are limited so donate soon to receive this Gift of the Month. Your donation to MAPS helps us to carry out our mission.
On September 16, the FDA permitted us to proceed with our clinical investigation, “A Phase I Placebo-Controlled, Double-Blind Crossover Study to Assess Psychological Effects of MDMA when Administered to Healthy Volunteers,” also referred to as our MDMA/PTSD therapist training protocol.
Through extensive discussions and cooperation with the FDA, the protocol meets two goals at once. On the one hand, it is designed as a Phase 1 randomized, placebo-controlled, double-blind study of the psychological effects of MDMA on healthy volunteers. On the other hand, enrollment is limited to subjects who are participating in our MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) therapist training program. The final draft of the protocol meets both the FDAs goals and MAPS goals. Now that we have the FDAs “may proceed” letter, we will be seeking approval from an Institutional Review Board (IRB).
We will be measuring the psychological effects of MDMA on “healthy normals” as contrasted with our international series of Phase 2 pilot studies evaluating MDMA-assisted psychotherapy in people who have treatment-resistant posttraumatic stress disorder (PTSD). We will employ some psychological measures that have not yet been used in an MDMA research project as well as some that we have used before. The psychological measures include measuring mood with the Profile of Mood States, personality with the Neuroticism-Extroversion-Openness (NEO) Inventory, interpersonal closeness with a nonverbal (visual analog) self-report measure, psychological symptoms with the Brief Symptom Inventory (BSI), and suicidality with the Columbia Suicide Severity Rating Scale (C-SSRS). As a crossover study, subjects will get placebo on one occasion and MDMA on the other.
The FDAs “may proceed letter marks a major turning point for MAPS. We now have the ability to offer one full-dose MDMA-assisted psychotherapy session to therapists who are preparing to conduct Phase 2 and Phase 3 MDMA/PTSD studies for MAPS. During these studies we will be gathering information about the psychological dynamics of MDMA-assisted psychotherapy. We believe that this new protocol substantially increases the chances that we will successfully conduct the next step in our mission: a Phase 3 multi-site pilot study with 20-30 co-therapist teams.
In light of the results from our US MDMA/PTSD pilot study and preliminary results from our Swiss and Israeli pilot studies, we have completed an overall review of our methodology and study documents used in our studies. We have incorporated what we have learned in revised versions of our MDMA/PTSD protocols and Case Report Forms (CRFs). The revised protocols are designed to be more efficient. We have narrowed down our research focus and have eliminated some redundant outcome measures from the protocols. Weve also added a measure of suicidality required by the FDA for all studies using drugs that have psychological effects.
One of the strengths of MAPS drug development approach is our willingness to do the extra work required to incorporate lessons learned in our protocols as they are in process. This fine-tuning is the essence of what Phase 2 pilot studies are all about. They are learning opportunities for the development and design of Phase 3 multi-site studies. The Phase 3 studies will evaluate in a large number of subjects the safety and efficacy of MDMA-assisted psychotherapy for the treatment of PTSD. The outcome of these Phase 3 studies will determine if the FDA and other regulatory agencies eventually approve MDMA for prescription use.
Were close to completing the protocol design for our upcoming U.S. MDMA/PTSD study exclusively for veterans of war. We plan to submit this protocol to the FDA in November 2009. A crucial protocol design meeting with Rick Doblin, Ph.D., Michael Mithoefer, M.D. and Ilsa Jerome, Ph.D. took place several weeks ago at Ricks home office. We will be using the Phase 2 study in veterans to test a possible design for our Phase 3 multi-site studies — our most sophisticated protocol design to date. We will provide more information about details of the protocol in an upcoming email newsletter.
On September 30, we submitted our draft protocol, informed consent, and Case Report Forms for our Jordanian MDMA/PTSD research to Principal Investigator Nasser Shuriquie, M.D. and his Jordanian research team, and to Clinquest JO, a Jordanian Contract Research Organization (CRO). We have decided to hire Clinquest JO to monitor the study in order to limit the amount of travel and resources that our U.S. monitoring team would have to expend to travel frequently to Jordan. Furthermore, Clinquest JO helped to establish the Jordanian FDA, are culturally situated to Jordan, and speak Arabic. We are impressed with their quality of work and will be pleased to work with them. Dr. Shuriquie introduced Kamila Novak, Ph.D. of Clinquest JO to MAPS Executive Director Rick Doblin Ph.D. when Rick was in Jordan on August 13, 2009.
On October 20, Rick and Michael Mithoefer, M.D. will go to Amman, Jordan to make a presentation about the research agenda to representatives of the Jordanian FDA, Dr. Shuriquie, Shuriquies co-therapist and others who may be involved in the study. Clinquest JO will bring several clinical research staff from Egypt to hear the presentation. MAPS is excited to be venturing through the doorway to the Arabic research world.
From October 18-23, Michael and Rick will attend the conference “Future Directions in PTSD: Prevention, Diagnosis and Treatment,” put on by the Institute for Advanced Studies at the Hebrew University of Jerusalem. Michael will present a poster on MAPS MDMA/PTSD pilot study at the conference. Michael and Rick will also meet with Efrat Yasur, founder of Transcom Global, an Israeli CRO. MAPS is hiring Transcom Global to monitor our Israeli MDMA/PTSD study.
MAPS research projects received a lot of attention in the media these past few weeks. On Sunday, September 27, the San Francisco Chronicle ran the cover story, “LSDs long strange trip back to the lab.” On September 29, The McGill Tribune published, “The Psychotherapy Movement: Acids long trip back to clinical research.” On October 1, Scientific American magazine printed “LSD returns – for psychotherapeutics. ” Next week, Discover magazine will release “Treating agony with ecstasy.”
A new article just published in Clinical Psychology Review, “Emerging treatments for PTSD”, has a section on MDMA. This review article comes as a total surprise. It’s wonderful to see MDMA is being mentioned as a possible treatment for PTSD by people we don’t even know. The authors quote an article MAPS Executive Director Rick Doblin, Ph.D. published in 2002 which was about MAPS’ MDMA/PTSD Clinical Plan. They also quote Andy Parrott, Ph.D. about MDMA’s therapeutic potential, even though he has mostly written about the risks of MDMA. Too bad they missed the Journal of Psychopharmacology article, “How could MDMA (ecstasy) help anxiety disorders? A neurobiological rationale,” which was published in March 2009.
From October 23-25, Canadian Students for Sensible Drug Policy (CSSDP) is hosting “Blueprints for Beyond Prohibition,” a conference in Vancouver, BC. On Sunday, October 25, at 10:00 AM, Rick Doblin, Ph.D. will present on a panel titled, “Drugs and Healing.” At 2:30 PM, Rick and Randolph Hencken, M.A., will present in a workshop about ibogaine as an addiction treatment.
During the last week of October MAPS Executive Director Rick Doblin, Ph.D. will be participating in the Evolver Intensives teleseminar, “The Future of Psychedelics: Exploring Their Potential for Insight and Healing.” Rick will be part of a two-week series of discussions with several guests hosted by Daniel Pinchbeck, author and founder of the web magazine Reality Sandwich. Among the other guests is Amanda Feilding, Director of the Beckley Foundation, the leading British research institution focusing on the science of drug use and the nature of consciousness. In this series of live, in-depth conversations, participants will be able to take part and ask questions. You can sign up to participate at: http://www.evolverintensives.com/Psychedelics
From November 12-14, 2009, MAPS will be co-hosting the Drug Policy Alliances International Drug Policy Reform Conference in Albuquerque, New Mexico. MAPS is working with a number of other organizations including the American Civil Liberties Union (ACLU), the Marijuana Policy Project, and many others to bring together all kinds of people who are interested in rethinking drugs and drug policy in the 21st century.
From September 25-27, about 350 people attended the third annual Horizons Conference, which took place at Judson Memorial Church in New York City. Experts from across North America and Europe gathered to discuss the ongoing renaissance in the exploration of psychedelic drugs. MAPS Deputy Director Valerie Mojeiko gave a thoughtful, personal and well-received presentation entitled, “Psychedelic Harm Reduction–Rethinking the ‘Bad Trip’.” Valerie was also mentioned in Psychology Todays Blog.
Its a rare pleasure to announce that registration will open next week for Psychedelic Science in the 21st Century, our April 15-18, 2010 conference in San Jose, California. This conference will be the largest gathering of psychedelic researchers in the United States in 17 years, since https://maps.organized a conference in 1993 for the 50th anniversary of the discovery of LSD. The list of presenters is incredible. Were also developing several pre- and post-conference workshops with Stan Grof and other presenters.
As part of our website upgrading project, were installing new store software. It will be ready next week, at which time we will announce the opening of registration in a separate email. You can also check www.maps.org/conference to see if registration is open. In the interim, here is the pricing structure and hotel information:
- General public early fee $225.00 [early registration ends December 31, 2009]
- General public full fee $275.00
- General public late fee $325.00 [late Registration begins March 15, 2010]
- M.D. early fee $375.00 [early registration ends December 31, 2009]
- M.D. full Fee $425.00
- M.D. late Fee $475.00 [late Registration begins March 15, 2010]
- Other medical professionals early fee $275.00 [early registration ends December 31, 2009]
- Other medical professionals full fee $325.00
- Other medical professionals late fee $375.00 [late Registration begins March 15, 2010]
Medical doctors and other medical professionals pay higher fees in order to receive continuing medical education credits. Medical doctors and other medical professional who do not want to receive CME or CE credits are welcome to pay the general admission rate.
- Scholarship rate $120.00
MAPS will provide 10 scholarship tickets for every 90 full price registrations sold.
- Media rate $120.00
- M.D. single day fee $200.00
- Other medical professionals single day fee $150.00
- General public single day fee $125.00
*All prices are for MAPS members. Non-MAPS members pay an additional $50. You are a MAPS member if you have made a donation to MAPS within the past 12 months. If you wish to become a MAPS member please visit our donate page. If you wish to check the status of your membership please call MAPS headquarters at 831-429-MDMA (6362).
The conference will be held at the Holiday Inn San Jose. You can register here for rooms at the conference hotel at our inclusive group rate:
*Room rates include most meals at the conference, including a reception on Thursday night, three meals on Friday, Breakfast and Lunch on Saturday and Sunday.
If you would like to have meals during the conference and choose not to stay at the Holiday Inn, meal vouchers must be purchased ahead of time for $20/meal (this does not apply to the benefit dinner on Saturday night). If you have more than two people in a double occupancy room, the additional person will need to purchase meal vouchers to dine at conference meals.
There will be a special benefit dinner on the evening of Saturday April 17 to raise funds for the conference, with guests of honor Ann and Alexander “Sasha” Shulgin, whose lifetime of achievements are inspiring. The benefit will cost $60 to attend and is not covered by the cost of the hotel room. Tickets may be purchased for the benefit dinner beginning in mid-October on the MAPS webstore.
We are in the process of creating pre- and post-conference workshops for our “Psychedelic Science in the 21st Century” conference. On Monday, April 19, Stanislav Grof, M.D. will conduct a daylong post-conference workshop. Other workshops are under development and will be announced when they are confirmed.
Our call for proposals for Psychedelic Science in the 21st Century is officially open. The priority deadline for proposal submissions is November 30, 2009.
We encourage you to submit a proposal if you:
- Have tested a hypothesis by collecting and analyzing data in a scientifically rigorous manner about psychedelic drugs, psychedelic experiences, or a related issue.
- Have (a) case report(s) about psychedelic drugs or psychedelic experiences, and the report(s) would add to the body of knowledge being presented at the conference.
- Are an expert on a therapeutic technique that is applicable to psychedelic psychotherapy.
- Are an expert on psychedelic crisis intervention techniques.
- Are an expert on how to help people who misuse psychedelic drugs.
- Are an expert in a unique area related to psychedelic drugs that is not represented by other speakers.
To submit a proposal, fill out the form titled “Psychedelic Science Presentation Application” on our website.
or fax it to 831-429-6370
or mail it to:
309 Cedar Street #2323
Santa Cruz, CA 95060
You should also visit MAPS on youtube, myspace, twitter, and facebook.
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