#65 - Rick Doblin, Ph.D.: MDMA— the creation, scheduling, toxicity, therapeutic use, and changing public opinion of what is possibly the single most important synthetic molecule ever created by our species

Aug 5, 2019 Episode Page ↗
Overview

Dr. Rick Doblin, founder and executive director of MAPS, discusses MDMA's history, its criminalization, and his lifelong work to legalize it for therapeutic use, especially for PTSD. He details scientific and political battles, including FDA breakthrough designation, offering hope for future access.

At a Glance
31 Insights
3h Duration
12 Topics
7 Concepts

Deep Dive Analysis

Introduction to Rick Doblin and MAPS's Mission

MDMA's Rediscovery and Emergence as 'Ecstasy'

Understanding Drug Scheduling and MDMA's Classification

MAPS's Legal Battles and Advocacy Against DEA

Debunking Exaggerated Risks and Neurotoxicity of MDMA

MDMA for PTSD: Marcella's Transformative Case Study

MDMA's Breakthrough Therapy Designation and FDA Path

Expanded Access and Future Vision for Psychedelic Clinics

Rick Doblin's Early Life, Draft Resistance, and Motivation

History of LSD: Discovery, Military Interest, and Psilocybin

Timothy Leary and the Good Friday Experiment

The Concord Prison Experiment and Recidivism Research

Schedule I Drug

A classification for drugs deemed to have a high potential for abuse, no accepted safety under medical supervision, and no currently accepted medical use. Examples include heroin, marijuana, LSD, psilocybin, and MDMA.

Empathogen/Intactogen

Terms used to describe MDMA, emphasizing its ability to produce empathy and 'touch within.' These terms were part of a legal strategy to differentiate MDMA from classic psychedelics.

Breakthrough Therapy Designation

An FDA program for the most promising drugs that show substantial improvement over existing therapies for serious conditions. This designation expedites development and review, with the FDA partnering closely with the drug developer.

Special Protocol Assessment (SPA)

A voluntary FDA program where a pharmaceutical company negotiates and agrees upon every aspect of a Phase 3 clinical trial design. If the trial achieves statistically significant efficacy with this design and no new safety issues arise, the FDA is legally bound to approve the drug.

Expanded Access (Compassionate Use)

An FDA program that allows patients with serious or immediately life-threatening diseases to gain access to investigational drugs outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

Set and Setting

Refers to the mindset (set) and physical/social environment (setting) in which a psychedelic experience takes place. These factors profoundly influence the nature and outcome of the experience, differentiating recreational use from therapeutic use.

Psychotomimetic

An early term used to describe LSD, meaning it 'mimics psychosis.' This classification reflected the initial belief that LSD temporarily induced a state similar to insanity, a view later challenged by researchers.

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What are the criteria for classifying a drug as Schedule I by the DEA?

A Schedule I drug is defined as having a high potential for abuse, no accepted safety under medical supervision, and no currently accepted medical use, placing it in the same category as substances like heroin.

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How did MDMA become illegal despite its therapeutic potential?

MDMA was criminalized on an emergency basis by the DEA in 1985, primarily due to its recreational use as 'ecstasy,' despite an administrative law judge's recommendation for a Schedule III classification and ongoing legal challenges from advocates.

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What were the exaggerated risks of MDMA, and have they been debunked?

Initial concerns included hyperthermia, hyponatremia, and severe neurotoxicity leading to depression or Parkinsonian syndromes. Research has largely debunked claims of permanent serotonin receptor damage or Parkinson's, clarifying that MDMA-related hyperthermia is rare and often linked to specific environmental factors.

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How does MDMA-assisted psychotherapy help individuals with PTSD?

MDMA reduces fear responses, allowing individuals to process traumatic memories and emotions in a safe, therapeutic setting. It facilitates emotional connection and integration of difficult experiences, often leading to profound healing.

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What is the significance of the FDA's 'Breakthrough Therapy' designation for MDMA?

This designation acknowledges MDMA's substantial potential for treating PTSD, a serious condition with limited effective treatments. It signals FDA's commitment to expedite the development and review process for MDMA-assisted psychotherapy.

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Can patients access MDMA therapy before it receives full FDA approval?

Yes, through the FDA's Expanded Access (compassionate use) program, which allows patients with treatment-resistant PTSD to receive MDMA-assisted psychotherapy under specific conditions, often while Phase 3 trials are still ongoing.

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Who is generally not a good candidate for MDMA-assisted psychotherapy from a safety perspective?

Patients with compromised hearts, uncontrolled hypertension, epilepsy, schizophrenia, or bipolar disorder are typically excluded. Those on certain psychiatric medications are usually asked to taper off before treatment.

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How does the 'set and setting' influence the effects of MDMA?

The user's intention and the environment profoundly shape the experience. In a therapeutic setting with inward focus, MDMA can facilitate deep emotional processing, while in a recreational setting, the focus tends to be external and social.

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What was the purpose of the Good Friday Experiment conducted by Timothy Leary?

The experiment aimed to scientifically investigate whether psilocybin could reliably induce genuine mystical experiences in religiously inclined individuals within a religious setting, using a specially designed questionnaire.

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What was the Concord Prison Experiment, and what were its findings regarding recidivism?

This experiment explored whether psilocybin-assisted therapy could reduce recidivism rates among prisoners. While initially reported as highly successful, later follow-up revealed methodological flaws and no significant difference in recidivism compared to a control group.

1. Heal Multi-Generational Trauma with Therapy

Recognize the potential of psychedelic therapy to heal multi-generational trauma passed on through epigenetics, breaking cycles of conflict within a single generation or even session by fostering connection and reducing dehumanization.

2. Explore Expanded Access for PTSD

If you suffer from treatment-resistant PTSD and other therapies have failed, investigate the FDA’s Expanded Access (compassionate use) program to potentially access MDMA therapy before its full approval.

3. Consider Phase 3 Trials for PTSD

If you have PTSD, volunteering for a Phase 3 trial offers effective therapy (even in the control group) and eventual access to MDMA, contributing to research while potentially receiving treatment.

4. Utilize MDMA in Therapeutic Setting

For processing trauma, engage with MDMA in a therapeutic setting focused on internal processing, allowing for safe integration and coming to peace with difficult experiences. This context encourages welcoming conflict rather than avoiding it.

5. Understand MDMA Contraindications

Avoid MDMA therapy if you have compromised heart conditions, uncontrolled hypertension, psychosis, schizophrenia, or bipolar disorder, as these conditions present significant safety or efficacy concerns.

6. Taper Psychiatric Meds Before MDMA

If considering MDMA therapy, be prepared to taper off other psychiatric medications, especially SSRIs, as they can blunt MDMA’s effects. This must be done under medical supervision.

7. Hydrate with Electrolytes During MDMA

When using MDMA, prioritize drinking fluids with electrolytes (like fruit juices) over plain water to prevent hyponatremia from over-hydration. This is a key harm reduction tip.

8. Mitigate Hyperthermia Risk with MDMA

If using MDMA (in legal contexts), avoid hot environments, excessive dancing, and ensure adequate fluid replacement to prevent hyperthermia, which can be a contributing factor to adverse events.

9. Prepare for Emotional Emergence (MDMA)

Be aware that MDMA can bring difficult emotions and past traumas to the surface due to its fear-reducing effects on the amygdala. This necessitates a supportive and prepared setting for processing.

10. Set Clear Intentions for Psychedelics

For profound healing, approach psychedelic experiences with an internal focus and an intention to welcome and process whatever emerges, including difficult emotions, within a safe therapeutic context.

11. Practice Surrender (Classic Psychedelics)

When using classic psychedelics (like psilocybin or LSD), embrace the art of surrender and ego dissolution, as resistance can intensify difficult experiences and hinder progress.

12. Embrace Difficult Experiences Non-Resistantly

When encountering difficult material during psychedelic therapy, aim to not resist it, as non-resistance allows for learning and growth, while resistance causes pain and stagnation.

13. Seek MDMA Co-Therapy Team

When pursuing MDMA therapy, look for a male-female co-therapy team, as this model is believed to be more effective, especially for trauma related to childhood and attachment disorders, by recreating a loving, supportive dynamic.

14. Undergo MDMA Therapy Training (Pro)

If you are a healthcare professional interested in providing MDMA therapy, you must complete a specialized training program to ensure proper administration and patient care, as required by the FDA.

15. Anticipate Future Psychedelic Clinics

Look forward to the opening of psychedelic clinics that will initially offer MDMA, ketamine, and psilocybin therapy for clinical diagnoses, with a future vision for personal growth, couples therapy, and mystical experiences for those without a diagnosis.

16. Advocate Licensed Psychedelic Legalization

Support efforts towards a system of licensed psychedelic legalization, allowing access for personal use (after an initial supervised experience) and medical use covered by insurance for specific diagnoses.

17. Watch “A Trip of Compassion”

To gain a deeper understanding of MDMA therapy for PTSD, watch the documentary ‘A Trip of Compassion’ to see patient experiences and the profound impact of the treatment.

18. Prioritize Psychedelic Integration

Understand that taking more psychedelics does not necessarily lead to faster evolution; prioritize a thorough integration process, which may take years, to ground experiences and work through personal fears.

19. Seek Psychedelic Integration Guidance

If you have powerful psychedelic experiences and struggle to integrate them, seek out resources like Stan Grof’s work or therapeutic guidance to help understand and process them.

20. Leverage MDMA’s Negotiable Experience

Unlike classic psychedelics, MDMA allows for some negotiation with difficult content, enabling users to manage the pace of emotional processing during a session.

21. Understand MDMA’s Unique Properties

Recognize that MDMA differs from classic psychedelics (like LSD or psilocybin) by not causing dissociation or hallucinations, allowing for a more awake and integrated experience that is closer to normal consciousness.

22. Rebuild Discernment After Trauma

Use therapeutic processing to re-evaluate past judgments and regain the ability to discern trust, especially after experiences that undermine self-trust, like date rape trauma.

23. Establish Therapy Safety Agreements

For high-risk situations (e.g., suicidal ideation), establish clear safety agreements with the patient as a prerequisite for engaging in intensive therapeutic work, ensuring a commitment to safety.

24. Consider MDMA-LSD Combination (Advanced)

If experiencing overwhelming fear or getting ‘stuck’ during a classic psychedelic (e.g., LSD) session, a low dose of MDMA might help soften the experience and facilitate processing of traumatic content. This is an advanced therapeutic technique.

25. Acquire Expertise for Complex Systems

If facing a complex regulatory or systemic challenge, consider gaining formal education and expertise in that specific domain to effectively navigate and influence it, as Rick Doblin did with his PhD.

26. Engage with Systems for Reform

Rather than solely opposing a system from the outside, recognize opportunities to work within established structures (e.g., through nonprofits or policy schools) to effect reform and create change from the inside out.

27. Cultivate Long-Term Purpose-Driven Vision

Identify a deep, multi-generational purpose (e.g., addressing long-term societal threats) and commit to it, leveraging personal freedom to pursue work that may not have immediate, conventional career paths.

28. Extend Compassion to Opponents

Cultivate empathy and compassion for those on the ‘other side’ of an issue, recognizing their potential struggles and offering solutions that could benefit them too, even if it feels awkward.

29. Advocate for Your True Beliefs

Only promote or advocate for things you are genuinely passionate about and believe in, as this ensures authenticity and enthusiasm, fostering trust with your audience.

30. Prioritize Unbiased Information Sources

Seek out information sources that are not influenced by advertising revenue, as this can compromise trust and objectivity in the content being presented.

31. Support Content Creators via Membership

If you value a podcast or content, consider becoming a member or subscriber to support it directly, fostering an honest relationship between creator and audience and gaining access to exclusive benefits like show notes and AMAs.

I feel that it's very rare that people who work on social justice movements live to see the change that they're working for.

Rick Doblin

The essence of doing the classic psychedelics is the art of surrender.

Rick Doblin

I still maintain to this day, though this I acknowledge is a slightly hyperbolic statement, I'm not convinced that there is a man-made molecule that is more important than MDMA.

Peter Attia

The world felt at risk. And so I felt that this imbalance that was in me that was also in the world and this ability of LSD to help me emotionally and spiritually.

Rick Doblin

Never forget, there's always a Harvard man on the wrong side of every issue.

Rick Doblin (quoting Lowell, an early Harvard president)

Who believes the law is unjust and breaks it and is willingly suffering the consequences to be an example of others actually has the highest regard for the law.

Rick Doblin (quoting Martin Luther King Jr.)

MDMA-Assisted Psychotherapy Protocol (MAPS)

Rick Doblin
  1. Patient receives MDMA in a therapeutic setting under the supervision of a male-female co-therapy team.
  2. Patient spends the night after the MDMA session under supervision.
  3. Patient receives integrative psychotherapy the next day.
  4. Patient returns home after the integrative session.
1912
MDMA first synthesized by Merck As an intermediary chemical, not for its psychoactive properties.
1953
US Army Chemical Warfare Service tested MDMA Tested for toxicity in animals; classified research, declassified in early 1970s.
1985
MDMA criminalized by DEA on emergency basis Later found to be without proper authority from the Attorney General.
1986
MAPS (Multidisciplinary Association for Psychedelic Studies) founded By Rick Doblin, to promote psychedelic research and therapy.
1992-1996
MDMA Phase 1 safety study duration First dose-response safety study, took 4 years to complete.
1999/2000-2016
MDMA Phase 2 pilot studies duration Six different studies conducted in Israel, Canada, Switzerland, and the US to prepare for Phase 3.
200 persons
MDMA Phase 3 studies total participants Two separate studies, each enrolling 100 participants.
End of 2021
Anticipated FDA approval for MDMA-assisted psychotherapy Estimated timeline for approval based on current progress.
$40 million
Estimated cost to make a psychedelic drug into a medicine Excluding initial political and advocacy work.
1938
LSD first synthesized by Albert Hoffman At Sandoz Pharmaceutical, as part of ergot derivatives research.
April 19, 1943
LSD's psychedelic properties discovered (Bicycle Day) Albert Hoffman intentionally self-administered 250 micrograms.
20 Christian divinity students
Good Friday Experiment participants Half received psilocybin, half placebo.
30 milligrams
Good Friday Experiment psilocybin dose Considered a major dose of psilocybin.
25 years later
Good Friday Experiment follow-up study Conducted by Rick Doblin to assess long-term effects.
~36 prisoners
Concord Prison Experiment participants Received psilocybin to study recidivism rates.