I'm reminded of something my mother often says: "If you don't know anything, you don't have to do anything." Well, we certainly have a lot to do these days.

Each new study and each new experimental session gives us another opportunity to refine our methods, improve our results, and move MDMA-assisted psychotherapy ever closer to approval as a legal treatment for posttraumatic stress disorder (PTSD).

Last week, our MDMA-assisted psychotherapy for PTSD research program reached a major milestone when the long-term follow-up results from our U.S. flagship study were submitted for publication in a scientific journal.

The results suggest that MDMA-assisted psychotherapy isn't just a short-term treatment, but may be a lasting cure for some people suffering from chronic, treatment-resistant PTSD.

Here are just a few highlights from this month's newsletter:

• Our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with PTSD expands from 16 to 24 subjects, enabling researchers to make stronger claims about treatment effectiveness.
• The protocol for our upcoming Australian study of MDMA-assisted psychotherapy for PTSD is completed and submitted to an Australian Ethics Committee.
• "The Principles of Psychedelic Therapy" workshop, led by MDMA-assisted psychotherapy researchers Dr. Michael Mithoefer and Annie Mithoefer, B.S.N., at Cartographie Psychedelica is now available online.
• British Columbia's chief medical official, Dr. Perry Kendall, recognizes the promise of MDMA-assisted psychotherapy on CBC Radio One.
• MAPS' research makes the front page of the Santa Cruz Weekly.

With your support, MAPS is healing people and transforming culture by developing psychedelics and marijuana into prescription medicines.

Sincerely, Brad Burge MAPS Director of Communications

MDMA Research:

1. U.S. Flagship Study: Results of Long-Term Follow-Up Submitted to Scientific Journal
2. U.S. Relapse Study: First Subject Screened
3. U.S. Veterans Study: Expanded from 16 to 24 Subjects
4. Australia: Protocol Submitted to Ethics Committee
5. Israel: Independent Rater Training Completed
6. MDMA-Assisted Treatment for Adult Asperger's Syndrome: Qualified Research Team Found

More Research:

7. Ibogaine: Fourth Subject Completes Follow-Up in Observational Study in Mexico

Fundraising:

8. Generous Contributions Make MDMA-Assisted Psychotherapy Research Possible

Media:

9. MAPS in the Media
10. Video: MDMA-Assisted Psychotherapy for PTSD Workshop at MAPS 25th Anniversary Conference
11. Video: Stan and Christina Grof Tribute at MAPS 25th Anniversary Conference
12. Audio: MAPS Executive Director Rick Doblin Interviewed on CKNW Radio Vancouver
13. Audio: British Columbia Chief Medical Official Discusses MDMA-Assisted Psychotherapy
14. Video: After EDC Documentary

Events:

15. IONS Entheogen Film Festival and Seminar: February 10-12, 2012, Petaluma, CA

16. High Times Medical Cannabis Cup: February 11-12, 2012, Los Angeles, CA
17. Institute of Transpersonal Psychology - Spirituality and Psychology Conference: February 17-19, 2012, Menlo Park, CA
18. IONS Total Immersion Noetic Film Experience: March 9-11, 2012, Petaluma, CA

More News:

19. MAPS Board of Directors Meets in San Jose, Calif.
20. A Letter from Psychedelic Harm Reduction Organization KosmiCare UK
21. Call for Papers: Deadline February 19: Mind Altering Science, June 1-3, 2012, Amsterdam
22. MAPS Staff Members Travel to India for a Much-Deserved Sabbatical

MDMA Research

1. U.S. Flagship Study: Results of Long-Term Follow-Up Submitted to Scientific Journal

On February 5, 2012, after extensive work, the lead investigator of our U.S. flagship study of MDMA-assisted psychotherapy for PTSD and co-authors submitted a paper describing the results of our long-term follow-up of subjects who participated in the flagship study. The paper was submitted to a peer-reviewed scientific journal and is now being reviewed for publication. In the original study, 17 of 21 subjects no longer qualified for a diagnosis of PTSD after treatment with MDMA-assisted psychotherapy. The long-term follow-up, conducted an average of 3.5 years after treatment, demonstrates that these benefits were, on average, maintained over time. Additionally, of the subjects who were seeing a therapist prior to the study, 45% were no longer seeing one at the time of the follow-up survey; and 55% of those who were receiving psychiatric medications prior to the study were no longer taking them. Two subjects who participated in the original study experienced a return of symptoms during the long-term follow-up period and will be offered enrollment in our relapse study of MDMA-assisted psychotherapy for PTSD, where they may receive one additional full-dose MDMA session.

2. U.S. Relapse Study: First Subject Screened

On January 20, 2012, the first of two subjects eligible for our relapse study of MDMA-assisted psychotherapy for PTSD was screened. This study will enroll two subjects whose PTSD symptoms eventually returned after participating in our U.S. flagship study of MDMA-assisted psychotherapy for PTSD, which was completed in July 2010. This is an open-label proof-of-principle study intended to test whether an additional MDMA-assisted psychotherapy session and several associated non-drug psychotherapy sessions can once again heal these subjects.

3. U.S. Veterans Study: Expanded from 16 to 24 Subjects

On February 10, 2012, MAPS' clinical team submitted a protocol amendment to the FDA with several important changes to our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with chronic, treatment-resistant PTSD. We've decided to increase the size of study from 16 to 24 subjects, enhancing the statistical power of the study and enabling us to make more conclusive observations about the therapeutic effectiveness of MDMA-assisted psychotherapy in veterans with service-related trauma. We hope that investigating a treatment for this especially vulnerable group will eventually lead to research funding from the U.S. Department of Defense and/or the Veterans Administration.

The amendments include the added possibility of enrolling firefighters and police officers suffering from PTSD as a result of their service. The addition of these subjects will increase local recruitment and reduce study costs, and will provide further evidence of MDMA-assisted psychotherapy's effectiveness for an important social group. The study design has also been changed to make the post-second session outcome assessment the primary endpoint for the study. PTSD symptoms will now be assessed after the second experimental MDMA-assisted psychotherapy session rather than the third, as in our upcoming Israeli and Australian studies. This will enable us to conduct a more accurate comparison of results across our international research sites, and to help clarify whether the best treatment model involves two or three experimental MDMA-assisted psychotherapy sessions. The sixth subject in this study was enrolled on January 12.

4. Australia: Protocol Submitted to Ethics Committee

On February 7, 2012, the protocol for our planned Australian study of MDMA-assisted psychotherapy for PTSD was submitted to an independent Human Research Ethics Committee (HREC). Subjects in this study will receive two experimental sessions instead of three (as in our U.S. flagship study), enabling us to compare the results with our upcoming Israeli study and helping us to determine whether two or three sessions is more efficient for use in our future Phase 3 studies. Once HREC approves the protocol, it will be submitted to the Australian Therapeutic Goods Administration (TGA) for review.

As in our ongoing study in U.S. veterans, this study will compare the effectiveness of a full dose (125 mg) and a low dose (30 mg) of MDMA in combination with psychotherapy. Unlike our U.S. veterans study, this study will omit the medium dose (75 mg) in order to determine whether we can achieve an effective double-blind with a two-arm (low and medium dose) study.

One of the ways we are expanding our capacity to conduct international clinical trials is by working closely with international affiliates. MAPS is collaborating with the newly formed Australian non-profit organization Psychedelic Research in Science and Medicine (PRISM) to design, fund, obtain approval for, and conduct this first-ever Australian study of the therapeutic application of MDMA.

5. Israel: Independent Rater Training Completed

On February 1, 2012, the independent rater for MAPS' upcoming Israeli study of MDMA-assisted psychotherapy for PTSD completed training on the Clinician-Administered PTSD Scale (CAPS). The CAPS is the primary outcome measure by which our research teams assess the severity of PTSD symptoms before and after treatment with MDMA-assisted psychotherapy. MAPS developed this training program in order to standardize how the CAPS is administered across our diverse study sites. The training includes reviewing of MAPS' training manual for independent raters, viewing videos of real CAPS interviews produced by the Veterans Administration, and completing assessments of the rater's ability to reliably administer the CAPS questionnaire. After a final meeting with the clinical team, the site will begin screening and enrolling subjects. Many of the Israeli subjects will be referred by the Israeli Defense Forces.

6. MDMA-Assisted Treatment for Adult Asperger's Syndrome: Qualified Research Team Found

On January 26, 2012, the MAPS clinical team finalized negotiations with a qualified research team who responded to our Request for Proposals for an upcoming study of MDMA-assisted treatment for Adult Asperger's syndrome. MAPS has agreed to contribute $10,000 for protocol development expenses. Asperger's syndrome is characterized by difficulties in interpreting social cues and nonverbal communication. This study will seek to evaluate how individuals experience certain types of empathy, as well as larger questions of global functioning, before and after MDMA-assisted treatments. The research team will collaborate with the MAPS clinical team to develop a protocol for submission to the FDA, enabling us to begin exploring a new indication within our overall research program into the risks and benefits of MDMA used in a therapeutic setting. We have preliminary budgeted $200,000 for this study, and will refine that estimate as the protocol is developed.

More Research

7. Ibogaine: Fourth Subject Completes Follow-Up in Observational Study in Mexico

On January 12, 2012, the fourth subject completed follow-up in our ongoing observational study of ibogaine treatment for addiction in Mexico. 22 out of 30 subjects are still in the follow-up portion of this study, which entails one year of evaluations of addiction and quality of life. The study's final long-term follow-up visit is scheduled for September 2012. Data from this study will be compared with data from our soon-to-be-initiated observational ibogaine study in New Zealand.

Fundraising

8. Generous Contributions Make MDMA-Assisted Psychotherapy Research Possible

The expansion of our MDMA-assisted psychotherapy for PTSD research program would not be possible without ongoing contributions from friends and supporters. This month, MAPS would like to thank the following individuals and foundations for their outstanding support:

• Peter Lewis, for his donation of $200,000 for our ongoing U.S. veterans study
• The Keeler Foundation, for $100,000 for direct costs on our ongoing U.S. veterans study
• Wendy Grace, for her $10,000 contribution to our upcoming U.S. intern study

Media

9. MAPS in the Media

Here's just a sample of the past month's psychedelic and medical marijuana research headlines:

• The front page article in the Santa Cruz Weekly tells the whole story: A traumatized veteran speaks out about how MDMA helped him, the black market widens the gulf between "Ecstasy" and pure MDMA, and MAPS finds real therapeutic benefit in MDMA-assisted psychotherapy for PTSD. (January 31, 2012)


• Nature reports that two new UK studies sponsored by the Beckley Foundation—one an fMRI brain imaging study for which MAPS donated $10,000 and one involving memory—have produced additional evidence for psilocybin's possible role in the treatment of anxiety and depression. (January 23, 2012)


• The Silicon Valley Metro reports that health officials are concerned about a rise in recreational Ecstasy use, and law enforcement and researchers agree that the danger lies not in the MDMA (which illegal Ecstasy may or may not contain) but in the uncertainty of the criminal black market. (January 25, 2012)


• The Oxford Student recaps the turbulent history of MDMA one century after its creation. From an unrecognized chemical to a widely used (and abused) party drug to a promising therapeutic tool, MDMA has challenged and excited researchers for generations. (January 22, 2012)


• The Huffington Post publishes a strong review of James Fadiman's pathbreaking new book, The Psychedelic Explorer's Guide: Safe, Therapeutic, and Sacred Journeys. (February 1, 2012)


• The Atlantic makes a compelling case for the federal government to allow MAPS' study of marijuana for veterans with PTSD to move forward, highlighting the need for state-level medical marijuana reform: In the struggle between legitimate medical research and irrational federal obstruction, veterans are the ones caught in the crossfire. (January 17, 2012)

10. Video: MDMA-Assisted Psychotherapy for PTSD Workshop at MAPS 25th Anniversary Conference

On Friday, December 9, MAPS MDMA-assisted psychotherapy researchers and co-therapists Michael Mithoefer, MD, and Annie Mithoefer, BSN, conducted a full-day workshop on the principles and practice of MDMA-assisted psychotherapy for PTSD. The workshop was part of Cartographie Psychedelica, MAPS' 25th anniversary conference and celebration in Oakland, Calif.

The workshop included an overview of historical and contemporary clinical psychedelic research, MAPS' therapeutic method for MDMA-assisted psychotherapy for PTSD, specific elements of MDMA-assisted psychotherapy treatment, reflections on current research, and stories from subjects who have participated in our groundbreaking trials.

Watch The Principles of Psychedelic Psychotherapy: Lessons from MDMA Research for PTSD.

Parts 2, 3, 4, and 5 are also available on YouTube. MAPS thanks Sam Sabzehzar for editing these videos and making them available online.

11. Video: Stan and Christina Grof Tribute at MAPS 25th Anniversary Conference

On December 10, 2011, MAPS staff, speakers, and pillars of the psychedelic research community gathered together for the Lumenarium tribute banquet to honor Stan and Christina Grof's incredible contributions to the development of transpersonal psychology and Holotropic Breathwork and to mainstreaming the field of psychedelic science worldwide. The Lumenarium was part of Cartographie Psychedelica, MAPS' 25th anniversary conference and celebration in Oakland, Calif.

The program included remarks by MAPS founder Rick Doblin, Stanislav and Christina Grof, Holotropic Breathwork teachers Tav and Cary Sparks, Holotropic Breathwork practitioners Ingrid Pacey and Sheelo and Ahmayo Bohm, author Rick Tarnas, psychologist Tom Roberts, psychiatrist Roger Walsh, psychedelic researchers Richard Yensen and Charles Grob, MDMA-assisted psychotherapy researchers Michael and Annie Mithoefer, visionary artists Alex and Allyson Grey, and more.

Watch the video of The Lumenarium tribute at Cartographie Psychedelica.

MAPS thanks Torsten Omananda for donating his time and skill to produce this video.

12. Audio: MAPS Executive Director Rick Doblin Interviewed on CKNW Radio Vancouver

On January 9, 2012, MAPS Founder Rick Doblin spoke with CKNW in Vancouver about recent headlines surrounding the dangers of recreational Ecstasy use, the benefits of MDMA-assisted psychotherapy for PTSD, and MAPS' efforts to conduct medical marijuana research.

Listen to Rick Doblin's interview (mp3).

13. Audio: British Columbia Chief Medical Official Discusses MDMA-Assisted Psychotherapy

On January 13, 2012, British Columbia's chief medical health officer, Dr. Perry Kendall, spoke on a province-wide call-in show on CBC Radio One. He starts off by talking about the medical potential of MDMA, its history as an adjunct to psychotherapy and current research on using it for treating PTSD.

Listen to the 30-minute show (mp3).

14. Video: After EDC Documentary

After EDC is an upcoming feature-length documentary about the fallout from the controversial event known as the Electric Daisy Carnival (EDC). The film highlights the importance of honest drug education, especially surrounding the illicit use of the street drug Ecstasy. In the summer of 2010, the Ecstasy-related death of a teenage girl who attended the massive dance festival inspired Los Angeles County to launch a long-term plan of action which included the distribution of safe-use literature, event staff training on crisis and overdose response, and other innovative measures that had never before been attempted by any agency in the United States. After EDC features the work and history of DanceSafe, a non-profit harm reduction organization promoting health and safety within the rave and nightclub community.

Watch the 6-minute trailer for After EDC.

Visit the film's fundraising campaign page to learn more about the project.

Events

15. IONS Entheogen Film Festival and Seminar: February 10-12, 2012, Petaluma, CA

Day passes are now available!

From February 10-12, 2012, MAPS invites you to participate in an exciting weekend event on the science and spirituality of psychedelics at the breathtaking EarthRise at IONS retreat center in Petaluma, CA. Presented by our friends at HopeDance FiLMs and facilitated by Ralph Metzner, PhD, the weekend experience includes more than 12 films and six seminars on the topic of psychedelic ("mind-manifesting") and entheogenic ("the divine within") plants and substances, including ayahuasca, ibogaine, LSD, MDMA, DMT, and cannabis.

MAPS Director of Marketing and Development Virginia Wright will be speaking at this event, and don't forget to visit the MAPS Store to learn more about the healing and spiritual potential of these powerful tools.

16. High Times Medical Cannabis Cup: February 11-12, 2012, Los Angeles, CA

Join MAPS at the High Times Medical Cannabis Cup at Los Angeles Center Studios from February 11-12, 2012. MAPS is hosting The Kaleidoscope Vault, an educational art lounge on the top floor of Los Angeles Center Studios. Network with experts in the medical cannabis research field and contribute to the exciting potentials of the cannabis community. Make sure to explore the Kaleidoscope Vault's collection of scientific knowledge and museum-quality masterpieces, with all proceeds going to MAPS.

17. Institute of Transpersonal Psychology - Spirituality & Psychology Conference: February 17-19, 2012, Menlo Park, CA

Online registration ends Thursday, February 15, with a 10% price increase at the door. Registration for live streaming of the conference is also now available.

From February 17-19, 2012, the Institute of Transpersonal Psychology will bring together clinicians, therapists, spiritual guides, healing practitioners, academics, and researchers from around the world to explore the promises and pitfalls of the spiritual path for the third biennial Spirituality & Psychology Conference. The conference will explore such themes as the relationship between culture and spirituality, transpersonally-oriented research, the cultivation of spiritual development, and the interface between spirituality and clinical practice.

MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, PhD, and MAPS intern Mason Schreck will be speaking at the conference about how spirituality informs the design and interpretation of clinical trials of psychedelic-assisted psychotherapy (abstract, pdf). Register and find out more about this exciting conference!

18. IONS Total Immersion Noetic Film Experience: March 9-11, 2012, Petaluma, CA

From shamanic healing and psi research to meditation, mythology, and personal transformation, the Institute of Noetic Science's inaugural Noetic Film Experience weekend will have something for everyone. Join us March 9–11, 2012, at the IONS EarthRise Retreat Center in Petaluma, CA, where we will celebrate the power of film while sharing our experiences via panels, receptions, and Q&A with filmmakers and scientists. The lineup includes

• The Sacred Science, a documentary about seriously ill people who travel to Ecuador to work with shamanic healers.
• The Dhamma Brothers, a powerful documentary about the introduction of meditation techniques into a high-security Alabama prison.
• Maya 2012, the definitive guide to the spellbinding prophecy.
• Finding Joe, which explores the work of mythologist Joseph Campbell and his focus on The Hero's Journey.
• Something Unknown..., considered by many to be the best film on parapsychology research ever made.
• And many others...

More News

19. MAPS Board of Directors Meets in San Jose, Calif.

On January 25, 2012, MAPS' semi-annual Board of Directors meeting took place in San Jose, Calif. at the home of Ashawna Hailey, our Board member who passed away in October 2011. The Board approved the continuation of the overall expense and project plan that was adopted at the previous meeting of August 2, 2011. Kim Hailey, Ashawna's twin brother, was in attendance and accepted an invitation to become an unofficial acting member of the Board, with his full membership to be decided at our next Board meeting this summer. The Board also extended an invitation to David Bronner of Dr. Bronner's Magic Soaps to become an unofficial acting Board member starting in January 2013, with full membership to be decided at our summer 2013 Board meeting.

20. A Letter from Psychedelic Harm Reduction Organization KosmiCare UK

Whether or not you live in the UK and can offer some help, this letter from KosmiCare UK is an effective example of how volunteers can help reduce the harms related to the recreational use of psychedelics. KosmiCare UK was initiated as an independent organization out of MAPS' CosmiKiva psychedelic welfare services at Boom Festival and continues to follow MAPS' model of psychedelic harm reduction and use its materials as required reading for volunteers. After a very successful, challenging, and rewarding time at Boom 2008, the KosmiCare UK crew started the project of establishing psychedelic welfare services in Britain, beginning with Sunrise Celebration in 2009.

21. Call for Papers: Deadline February 19: Mind Altering Science, June 1-3, 2012, Amsterdam

The OPEN Foundation for interdisciplinary psychedelic research is now accepting papers for its next conference, Mind Altering Science 2012. The deadline for submission is February 19. With researchers and therapists from a wide variety of academic disciplines, this event will be dedicated to the exploration of a broad range of subjects relating to scientific research into psychedelic substances and the psychedelic experience. MAS was first organized in 2010; MAS2012 will be the second installment. The organizers welcome papers from the broad and interdisciplinary field of psychedelic science. Researchers who are still in the process of writing are also strongly encouraged to submit. Poster presentations are also welcome to apply. Papers can be submitted through this online form.

22. MAPS Staff Members Travel to India for a Much-Deserved Sabbatical

MAPS Deputy Director Valerie Mojeiko and MAPS Director of Finance and Information Technology Josh Mojeiko have embarked on a much-deserved sabbatical and delayed honeymoon in India. Valerie has volunteered and worked with MAPS for over 11 years, and Josh for more than 5 years, and their combined skill and creativity have been vital to MAPS' outstanding growth. Josh and Valerie were married on June 18, 2011, at City of Rocks State Park in southern New Mexico. The rest of MAPS wishes them well as they explore the world.