Rick Doblin: Canceling PTSD with MDMA – The After On Podcast (Part 1)

Check out The After On Podcast Episode Page & Show Notes

Key Takeaways

  • Many more people have PTSD from non-military causes than military causes
  • Suicide attempts are carried out by 28% of PTSD sufferers
  • Roughly $20 billion per yer is paid out in disability payments to PTSD sufferers in the U.S.
  • Results of a recent Phase II clinical trial examining the effectiveness of using MDMA in conjunction with talk therapy to treat PTSD:
    • Of the people who had therapy + no MDMA, 23% no longer had PTSD at the 2-month follow up
    • Of the people who had therapy + MDMA, 56% no longer had PTSD at the 2 month follow up
      • At the 1-year follow up, this number jumped to 68%
    • The treatment worked regardless of the cause of the PTSD (even complex PTSD caused by things like childhood sexual abuse)
  • Phase III clinical trials examining MDMA’s effectiveness at treating PTSD are currently underway
  • It is estimated that by the end of 2021, MDMA will be approved for the treatment of PTSD
    • It’s estimated that the treatment will cost between $10-15k
  • MAPS is planning some studies with MDMA for eating disorder patients (because of its ability to facilitate self-acceptance)

Intro

What is PTSD?

  • It’s technically whatever is measured by the clinician administered PTSD scale (CAPS )
    • It’s the gold standard for evaluating PTSD symptoms
  • One of the main hallmarks of PTSD is the presence of intrusive memories
    • Very often, past traumas revisit PTSD patients, triggered by certain sights/sounds that remind them of the trauma
  • In the most extreme cases people refuse to leave their house
  • PTSD is often linked with depression and substance abuse disorders

Who tends to have PTSD?

  • There are roughly 8-10 million people in America with PTSD
  • “It’s a peculiar American phenomena that we identify PTSD with war”
    • It’s also common with people who are crime/sexual assault victims as well as those who have survived national disasters
    • “Way more people have PTSD from non-military causes than military causes”
      • (Effectively 8-10x more people in the U.S.)

The Human Toll

  • PTSD increases the risk of related death by a third
  • Suicide attempts are carried out by 28% of PTSD sufferers
  • Veterans with PTSD are 50% more likely to be unemployed
  • PTSD suffered are 3x more likely to have multiple marriages that end in divorce

Zoloft and Paxel

  • The only current drugs approved by the FDA for PTSD are Zolof and Paxel
    • They tend to work better in women than men
    • They also don’t tend to treat combat-related PTSD
    • “They are effective in about 40-50% of people at reducing symptoms” (not curing)
  • Does psychotherapy work?
    • Not really
    • Many people just stop going 
    • It requires you to talk about your trauma, and this in turn is re-traumatizing/triggering

The Economics

  • As of several months ago the Veterans Administration (the VA) had 1,370,000 people receiving disability payments for PTSD
    • As of 2005, those PTSD disability payments averaged $20k/person annually (equaling about $20 billion/year)

MAPS MDMA Phase II Clinical Trials – Part 1

  • In the Phase II clinical trials, Rick and his team tried to determine if MDMA treatment works with only certain kinds of PTSD or anyone who has PTSD regardless of the cause
  • These studies targeted “chronic, treatment-resistant” PTSD
    • Chronic = 6+ months – “Once people have had PTSD for 6 months, they very likely won’t get better on their own”
    • Treatment-resistant = people must of had to fail with previous medications/psychotherapy
  • In the MAPS Phase II studies, the average person had suffered from PTSD for 17.8 years

MAPS MDMA Phase II Clinical Trials – Specifics

  • What was the protocol?
    • 3 90-minute non-drug psychotherapy sessions were given prior to the first MDMA session, after which 3 more 90-minute non-drug psychotherapy sessions were held
      • During these first 3 sessions, the therapist focused on getting to know the patient and allow a sense of safety to develop (thus allows the patient, when they’re under the influence of MDMA, to be fully vulnerable)
    • Then, one month after the first MDMA session, another dose of MDMA was administered, after which 3 final 90-minute non-drug psychotherapy sessions were held
    • Two months after the second MDMA session, the primary outcome was measured (patients were re-evaluated 3 months later)
  • This was a double blind study
    • So one group of participants received a very low dose + therapy, while another group received a therapeutic dose + therapy (this way, everyone would say they felt something)
      • Low dose = 25 mg
      • Therapeutic dose = 35-45 mg
  • Who administered the MDMA?
    • A male/female team, mimicking the parental structure
  • What did the MDMA sessions look like?
  • Other details:
    • Patients wear eye shades and headphones with music to better facilitate a peaceful mood
      • The music (always without words – to avoid planting imagery) changes to be more energetic as the MDMA is at it’s peak and patients are trying to deal with difficult trauma

The Lengthy Process to Become an MDMA Therapist for the Studies

  • Therapists who administer the MDMA go through 14 hours of online training, a full week of in-person training, and an MDMA experience themselves
    • Why the latter? – “We think that therapists who want to give MDMA to their patients will be more effective if they’ve done MDMA themselves”
      • “Even therapists who’ve had MDMA in a recreational setting, when they take in in our therapeutic setting, they see it’s much different”
  • Therapists also have to sit to observe a therapy session as a trial run
  • THEN – they have to have to role play certain instructed scenarios (situations which they may experience during an administered MDMA session, videotaped) which are then reviewed by a MAPS therapy training team to provide feedback
  • FINALLY – they have to work with one PTSD patient under supervision

The Results of the Phase II Clinical Trials

  • A total of 107 different PTSD patients were included in the study
    • 29% of the patients had used MDMA before
  • The primary findings:
    • That they could treat people safely (no one overheated etc.)
    • That patients were not more prone to MDMA addition after the treatment
      • Only 8% of participants reported using MDMA after the treatment
    • The treatment worked regardless of the cause of the PTSD
      • Even complex PTSD (caused by things like childhood sexual abuse)
    • At the low doses (25 mg) there was an “anti-therapeutic effect”
      • The people who had only therapy without MDMA had better results than those who received therapy + a low dose (25 mg)
      • Why – “It activates people, but doesn’t reduce fear enough, so the trauma they’ve been unable to process….now they’re in a situation where they’re asked to focus on it, which can be very tough”
    • Of the people who had therapy + no MDMA, 23% no longer had PTSD at the 2-month follow up
    • Of the people who had therapy + MDMA, 56% no longer had PTSD at the 2 month follow up mark
      • At the 1-year follow up, this number jumped to 68%

How does MDMA work to heal trauma?

  • “There’s basically a membrane between the conscious and the subconscious, and psychedelics/MDMA make this membrane more permeable to emotionally charged material”
    • “We have this belief that there’s this order to what people think of and feel when they’re under the influence of MDMA that is beyond their conscious control but is somehow or other to be respected”
  • In an MDMA experience, the patient is able to carefully examine their trauma and begin to recognize it as just an event that’s part of their story, without the negative emotional response
  • Unlike a shaman who administered psychedelics who is known as a “healer” – “We believe we are empowering people to heal themselves

A Bit More About MDMA

  • It takes effect in about 30-60 minutes
  • People are often blissful, empathetic, extremely happy, relaxed, and much better able to deal with past anxieties
    • There’s a large release of oxytocin – a hormone of love/bonding
  • It make people feel a large degree of self-acceptance

The Phase III MDMA/PTSD Clinical Trials

  • In the preliminary Phase 3 trials (where therapists, in their last stage of training, administer a trial run MDMA dose to a PTSD patient), the results are even better than Phase II
    • Of the 31 patients, 74% no longer qualified for a diagnosis of PTSD (20% had a reduction in symptoms)
  • Two things to notes:
    • For these trials. MAPS went through what is known as a Special Protocol Assessment Process and recently received their acceptance letter from the FDA
      • What does this mean? – Once you’ve been approved to go to Phase III trials, you can elect to go through an extensive FDA review process (which delays things by 6-12 months)
        • You engage the FDA in a series of meetings about the exact protocol you plan to use for your Phase III studies, your statistical analysis plan, and answer all the FDA’s questions about toxicity and abuse liability
        • (you basically agree on all the end points and the design of Phase III)
      • With this agreement letter, the FDA is legally bound to approve the drug if you garner statistical evidence of efficacy and if no new safety problems arise
    • MAPS was also granted breakthrough therapy status
      • This is the FDA’s program for what they consider to be the most promising drugs
      • This results in shorter review times and makes it much easier to call more meetings with the FDA should any questions arise

Phase III Specifics

  • The FDA requested a minimum of 200 subjects (which will be split into two 100 subject groups)
  • The FDA has permitted something known as “interim analysis”
    • For background – the bigger the “effect size” of the drug, the fewer people you need to show statistical significance
      • (So you want to design the trial with enough people to show statistical significance, but not too many that it’s so expensive”
      • So at the completion of 60 treatments, a data review board will review the unblinded data (while the study is still in process) to determine if more study participants need to be added in order to reach statistical significance
  • It will end up costing $40-50k per patient 
    • Rick suspects that getting the treatment will cost $10-15k once it’s approved
  • Right now, 19/100 people have enrolled and are in the process of going through therapy
  • Rick estimates that by the end of 2021, MDMA will be approved for the treatment of PTSD

Additional Notes

  • MAPS is planning some studies with MDMA for eating disorder patients (because of its ability to facilitate self-acceptance)
  • The cxtent of trauma:
    • Trauma doesn’t end after one generation – it can be passed down to offspring genetically
    • Roughly 90% of people who experience trauma don’t develop PTSD
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