Medical Research

Multidisciplinary Association for Psychedelic Studies

  • Santa Cruz, CA
  • http://www.maps.org

Mission Statement

MAPS' mission is to develop psychedelics and marijuana into prescription medicines; educate therapists in psychedelic therapy; build a network of clinics where treatments can be provided; and to educate the public honestly about the risks and benefits of these substances.

Main Programs

  1. MDMA-assisted Psychotherapy Drug Development Plan
  2. Marijuana in 70 Veterans with Chronic Treatment-Resistant PTSD
  3. Public Education
  4. Zendo Harm Reduction Project

service areas

International

Self-reported by organization

ruling year

1986

chief executive

Rick Doblin Ph.D.

Self-reported by organization

Keywords

clinical trials research FDA psychedelic marijuana MDMA LSD ibogaine drug PTSD psychotherapy psilocybin ayahuasca addiction trauma cancer end-of-life palliative anxiety

Self-reported by organization

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EIN

59-2751953

Physical Address

Santa Cruz, CA

Also Known As

MAPS

Contact

Cause Area (NTEE Code)

Other Medical Research N.E.C. (H99)

Mental Health Treatment (F30)

Research Institutes and/or Public Policy Analysis (R05)

IRS Filing Requirement

This organization is required to file an IRS Form 990 or 990-EZ.

Programs + Results

How does this organization make a difference?

Impact statement

MAPS primary project is to investigate MDMA-assisted psychotherapy as a novel treatment for PTSD in clinical trials conducted under U.S. FDA regulations. Our goal is to ease the suffering of many thousands of people worldwide who have experienced psychological trauma.

Programs

What are the organization's current programs, how do they measure success, and who do the programs serve?

Self-reported by organization

Program 1

MDMA-assisted Psychotherapy Drug Development Plan

MDMA-assisted psychotherapy is an innovative treatment that combines psychotherapy with the administration of MDMA, an off-patent pharmacological adjunct. MDMA (3,4-methylenedioxymethamphetamine) is widely recognized for its ability to decrease fear and defensiveness while increasing trust and empathy.

MDMA opens a “window of tolerance” in patients undergoing psychotherapy for PTSD—and holds it open long enough for them to step through. MDMA makes it easier for patients to be comfortable between the extremes of fear and avoidance, and increases the effectiveness of psychotherapy by strengthening the alliance between therapist and patient. MDMA promotes the release of oxytocin and prolactin, hormones associated with trust and bonding, helping patients discuss their painful memories openly and honestly.

In MAPS’ initial US Phase 2 pilot study, 83% of the subjects receiving MDMA-assisted psychotherapy no longer met the criteria for PTSD, after suffering from treatment-resistant PTSD for an average of over 19 years. These results were published in the July 2010 issue of the Journal of Psychopharmacology. A long-term follow-up study conducted an average of 3½ years after the first study revealed that, on average, these benefits were sustained. These results were published in the November 2012 issue of the Journal of Psychopharmacology.

Our MDMA-assisted psychotherapy drug development plan includes Phase 2 clinical studies currently underway in Boulder, CO, Charleston, SC, Beer Yaakov, Israel, and a study in the start up phase in Vancouver, Canada.

MAPS’ MDMA-assisted psychotherapy drug development plan estimates expenses of about $3 million over the next three years to complete our international series of Phase 2 pilot studies. We estimate that roughly $16 million over the following seven years will be needed to complete Phase 3 and obtain FDA approval for the prescription use of MDMA-assisted psychotherapy for PTSD. Phase 3 expense estimates will become clearer after our End-of-Phase 2 meeting with FDA, the purpose of which is to determine the design of the Phase 3 studies.

We are actively looking for individuals and institutions that are interested in investing in developing MDMA-assisted psychotherapy into a treatment for PTSD sufferers. We are fortunate to have a temporarily restricted fund of $5 million for our Phase 3 studies, currently invested at the San Francisco Foundation, and we have been successful in raising the funds needed to date for Phase 2. We are challenged yet confident about our ability to raise funds for the remaining study costs.

Category

Pharmaceuticals

Budget

$19,000,000.00

Population Served

General Public/Unspecified

Military/Veterans

None

Program 2

Marijuana in 70 Veterans with Chronic Treatment-Resistant PTSD

In this randomized, placebo-controlled, double-blind crossover pilot study, marijuana will be tested as a pharmacological agent to manage PTSD symptoms in 70 veterans with chronic, treatment-resistant post traumatic stress disorder (PTSD).This will be the first controlled clinical trial testing this specific therapeutic potential of marijuana and will investigate the premise that using marijuana eases the symptoms of PTSD with a sufficiently favorable risk profile. Two drug-delivery methods, smoking and vaporizing, will be examined with four marijuana strains each with a different level of D9-tetrahydrocannabinol (THC, 0.0 %, 2 %, 6 %, 12 %) along with a fifth strain containing equal potencies of THC and cannabidiol (CBD, 6% THC, 6% CBD).

During Stage 1, 70 outpatient subjects will self-administer up to 1.8 grams of one of five different potencies of marijuana daily for four weeks, followed by a two week period of medication washout. Subjects will be given a one week supply of marijuana at a time, saving any unused marijuana each day in the original packaging for return to the study staff for weighing prior to receiving the next week’s supply. Stage 2 will be a randomized, blinded, crossover involving another 4-week period of marijuana use followed by 2 weeks of cessation. There will be an optional Stage 3 extension that will assess participants who request to consume the remaining marijuana that they previously returned. Assessments of PTSD and depression symptoms will be conducted prior, during and after after cessation of use.

The Principal Investigator is Dr. Suzanne Sisley, M.D. Assistant Professor, Internal Medicine/Psychiatry, The University of Arizona College of Medicine-Phoenix, Scottsdale AZ. Dr. Michael Mithoefer is the Medical Monitor. Dr. Mithoefer has designed and implemented four FDA-approved clinical trials administering MDMA-assisted psychotherapy for the treatment of PTSD, and has served as medical monitor for seven clinical trials. He is currently the PI in clinical study of the safety and efficacy of MDMA-assisted psychotherapy for veterans and firefighters with PTSD.

We estimate that the study will begin in July 2014, once final approval has been received from the DEA and marijuana has been received from NIDA. The study takes 15 months for each participant, with the follow-up visit occurring 12 months after the end of the last visit. Assuming that ten participants can be enrolled each month, the study should take approximately 29 months to complete. In the first year of the study, start-up activities will be completed and the first 20 subjects will be enrolled. In the second year, the remaining 50 subjects will be enrolled. Data collection and analysis will be completed in the third year.

Category

Pharmaceuticals

Budget

$885,000.00

Population Served

Military/Veterans

None

None

Program 3

Public Education

MAPS produces a number of educational projects, including publishing the tri-annual MAPS Bulletin, sharing a monthly email newsletter, publishing books relevant to our mission, maintaining educational websites such as mdmaptsd.org and mdma-autism.org, engaging with diverse audiences through social media, offering webinars, and more.

In fiscal year 2013, for example, MAPS educational publications and advocacy included publishing three editions of the Maps Bulletin; developing and managing three websites about psychedelic research; producing and distributing 12 monthly email newsletters; implementing media and public relations campaigns with international television, radio, print, and online journalists and press organizations; and publishing two new books: a revised edition of Claudio Naranjo’s “The Healing Journey, and the first English translation of Torsten Passie’s “Healing With Entactogens.

Educational events included the Psychedelic Science 2013 conference, our largest non-research activity, held in April 2013. Over 1,900 people attended the conference and associated events over the five-day event in Oakland, Calif., which presented over 100 speakers from more than 30 countries. In addition, MAPS staff attended more than 18 events organized by others; secured speakers for those and other events; managed exhibit booths and art galleries; sold books and maps Bulletins; and distributed free clinical protocols and peer-reviewed Journal articles.

Category

Communications & Public Education

Budget

Population Served

Adults

None

None

Program 4

Zendo Harm Reduction Project

Through the Zendo Project, MAPS offers an onsite harm reduction service that provides tranquil space and compassionate care for individuals having difficult psychedelic experiences. The Zendo Project:
• Provides a supportive space for individuals undergoing difficult psychedelic experiences or other psychological challenges in order to turn those experiences into opportunities for learning and personal growth, and to reduce the number of drug-related psychiatric hospitalizations;
• Creates an environment where volunteers can work alongside one another to improve their harm reduction skills and receive training and feedback;
• Demonstrates that safe, productive psychedelic experiences are possible without the need for law enforcement-based policies.

Each year Zendo Project services are offered at about a half-dozen Festivals internationally. In 2013, services were offered in: Envision Festival In Uvita, Costa Rica; 70th Anniversary Bicycle Day Party, San Francisco, California; Burning Man, Black Rock City, Nevada; and Afrikaburn, Tankwa, South Africa

Category

Communications & Public Education

Budget

$30,000.00

Population Served

Adults

None

None

Charting Impact

Five powerful questions that require reflection about what really matters - results.

Self-reported by organization

  1. What is the organization aiming to accomplish?
    Major Goals as of June 2013
    • Complete Phase 2 trials and begin Phase 3 trials of MDMA-assisted psychotherapy for PTSD. (3-4 years)
    • Make MDMA into a prescription medicine and institute training and licensing mechanism. (8-10 years)
    • Build a network of clinics where treatments can be provided. (10-20 years)
  2. What are the organization's key strategies for making this happen?
    MAPS’ overall strategy is to work with international regulatory bodies to conduct clinical research into the healing potential of psychedelic and psychoactive drugs. MAPS uses these drugs to treat conditions for which conventional medicines provide limited relief and to treat conditions which have a great need and high profile. MAPS communicates its findings through an active public relations campaign, conferences and publications, and will eventually treat patients through a network of trained therapists and clinics. The strategy is to prove these drugs’ healing potential, and then to communicate that to a large audience, eventually gaining wide acceptance of their benefit to society.
  3. What are the organization's capabilities for doing this?
    Founder and Executive Director Rick Doblin has strong fundraising and public relations skills, and has a strong grasp of what it takes to bring a schedule 1 drug to market.
    Excellent relationship with the FDA
    Excellent relationship with media outlets, both mainstream (NYT, CNN, National Geographic, Nature, Rolling Stone), military (Military.com, Stars and Stripes), and extensive online and alternative media. See maps.org/media.
    Strong publishing history
    Experienced staff in director roles (clinical, development, and communications)
    Small, flexible Board that contributes generously
    High-profile donors that are willing to ask others for their support
    Have identified a cadre of "expert" consultants in FDA policy, DEA policy, and nonprofit and business accounting, and legal issues
  4. How will they know if they are making progress?
    These achievements all indicate progress towards our goals:
    • Approval for six MDMA clinical studies by IRB, FDA, and DEA
    • Approval for one Marijuana-PTSD clinical study by IRB, FDA, DEA and HHS
    • Study results published in peer reviewed journals:
    "The Safety and Efficacy of MDMA-Psychotherapy in Subjects with Chronic, Treatment Resistant Post-Traumatic Stress Disorder, The First Randomized Controlled Pilot Study," 2010, Journal of Psychopharmacology
    "Durability of Improvement in PTSD symptoms and Absence of Harmful Effects or Drug Dependency after MDMA: A Prospective Long-Term Follow-up Study," 2012, Journal of Psychopharmacology.
    "A Randomized, Controlled Pilot Study of MDMA-Assisted Psychotherapy for Treatment of Resistant, Chronic PTSD in Switzerland," 2013, Journal of Psychopharmacology
    "Safety and Efficacy of LSD-Assisted Psychotherapy for Anxiety Associated With Life-threatening Diseases," 2013, The Journal of Nervous and Mental Disease
    "Ayahuasca-Assisted Therapy for Addiction: Results from a Preliminary Observational Study in Canada," 2013, Current Drug Abuse Reviews
    • Extensive Media coverage See: maps.org/media
    • MAPS is fiscally sound, has never had a budget deficit in 27 years, and is building a cash reserve for Phase 3 MDMA-Assisted psychotherapy which is currently at $5.3 million.
  5. What have and haven't they accomplished so far?
    MAPS has completed three clinical studies of psychedelic drugs, and has seven approved by the regulatory agencies that govern them. (British Columbia, South Carolina (2), Colorado, Israel, California, and Arizona.) We have $9 million in cash invested at the San Francisco Community Foundation, with approximately $5.3 million restricted to Phase 3 MDMA drug studies. We are managing growth in a responsible way, slowly adding staff and improved business processes as needed, without deficit spending. Our next big progress marker is to meet with the FDA in 2015 and get approval for our Phase 3 studies. It seems likely that this will happen. Other progress markers will be to receive funding from a major medical research foundation, and/or the National Institute for Mental Health. A significant measure of success will be to get FDA approval for MDMA-Assisted psychotherapy for PTSD as a prescription medicine. We will then use the resources from the sale of of that therapy to fund additional studies on additional drugs and indications.

service areas

International

Self-reported by organization

Social Media

@mapsmdma

@mapsnews

@u/0/114671001319740333157/posts

@mapsmdma

Funding Needs

As of February 2011, MAPS' top priority research project is a study of MDMA-assisted psychotherapy in US veterans with chronic posttraumatic stress disorder (PTSD), mostly from Iraq and Afghanistan and a few from Vietnam. The study will cost about $500,000 and we have raised $400,000 so far. The first subjects were treated in January 2011.

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Financials

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MULTIDISCIPLINARY ASSOCIATION FOR PSYCHEDELIC STUDIES
Fiscal year: Jun 01-May 31
Yes, financials were audited by an independent accountant.

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Operations

The people, governance practices, and partners that make the organization tick.

Multidisciplinary Association for Psychedelic Studies

Leadership

NEED MORE INFO ON THIS NONPROFIT?

Free: Gain immediate access to the following:
  • Address, phone, website and contact information
  • Forms 990 for 2014, 2013 and 2012
  • Board Chair and Board Members
  • Access to the GuideStar Knowledge Base Search
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CHIEF EXECUTIVE FOR FISCAL YEAR

Rick Doblin Ph.D.

BIO

MAPS Founder and Executive Director Rick Doblin received a Ph.D. in Public Policy in 2001 from Harvard's Kennedy School of Government, where he also obtained a Master's in Public Policy in 1990. His dissertation was on the regulation of the medical use of psychedelics and marijuana, and is posted on the MAPS website. Rick has studied with Dr. Stan Grof, and was in the first group to become certified as Holotropic Breathwork practitioners. He has published several papers, including a follow-up study to Walter Pahnke's Good Friday experiment and Timothy Leary's Concord Prison experiment.

STATEMENT FROM THE CEO

"It has taken work across several generations, and will likely require several generations more, to realize the mission of the Multidisciplinary Association for Psychedelic Studies (MAPS), which I founded in 1986. However, we are making great progress on achieving our goals.

We have seven studies of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) initiated or in the final stages of the approval process. We are sponsoring Phase 2 pilot studies in South Carolina, Colorado, Canada, and Israel, along with a Phase 1 psychotherapist training protocol, and a Phase 2 Relapse Study. We anticipate holding our crucial End-of-Phase 2 meeting with the FDA at the end of 2015. In this meeting we will plan our pivotal multi-site Phase 3 studies designed to gather proof of safety and efficacy required for prescription approval for MDMA-assisted psychotherapy for PTSD.

MAPS continues to receive positive coverage of its work in major media outlets, and reaches thousands of people through its website, Bulletin, and MAPS published books and events. In April 2013, MAPS hosted its third international psychedelic research conference, which drew 1,900 attendees from 33 countries, attracted major media attention and provided a place for researchers to share their most recent findings with each other and the general public. Our psychedelic harm reduction program has provided volunteer training and services for individuals having difficult experiences in Portugal, Central America, South Africa and the US, in the last year alone.

The momentum is building. We have an incredible amount of work to do, but with the help of the international community we are closer than ever to accomplishing our goals and helping create a world where psychedelics are safely and legally available for beneficial use, and where research is governed by rigorous scientific evaluation of their risks and benefits."

Governance

BOARD CHAIR

Rick Doblin

MAPS

BOARD LEADERSHIP PRACTICES

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BOARD ORIENTATION & EDUCATION

Does the board conduct a formal orientation for new board members and require all board members to sign a written agreement regarding their roles, responsibilities, and expectations?


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CEO OVERSIGHT

Has the board conducted a formal, written assessment of the chief executive within the past year?


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ETHICS & TRANSPARENCY

Have the board and senior staff reviewed the conflict-of-interest policy and completed and signed disclosure statements in the past year?


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BOARD COMPOSITION

Does the board ensure an inclusive board member recruitment process that results in diversity of thought and leadership?


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BOARD PERFORMANCE

Has the board conducted a formal, written self-assessment of its performance within the past three years?