Balázs Szigeti, PhD and David Erritzoe, PhD – Microdosing Research and the Effects of a Self-blinded Study

Balázs Szigeti, PhD and David Erritzoe, PhD

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In this episode, hosts Kyle and Joe interview Balázs Szigeti, PhD and David Erritzoe, PhD to discuss the self-blinded microdosing study in collaboration with the Imperial College London.
In this episode, they explore the self-blinding study and it’s pros and limitations, with the aim to collect data on microdosing and its possible benefits.

**Update as of 1/22/2018 – The plant psychedelic study extension was approved, together with the extension that allows for volumetric dosing.

3 Key Points:

  1. Microdosing (LSD) has the least amount of research so far among research on drugs like Psilocybin, MDMA and Ketamine.
  2. This microdosing study includes a procedure on how self-experimenters can implement placebo control. This will help determine whether microdosers feel benefits due to the placebo effect or because of the pharmacological action of the microdose.
  3. Just because microdosing may have a placebo effect (the way a user feels while taking it) it may actually have benefits that one cannot necessarily ‘feel’ (users may become more creative, have better problem-solving skills, etc).

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Show Notes

About Balázs

  • Balazs attended his undergrad in the UK at Imperial College and studied Theoretical Physics
  • He moved to Scotland to get his Ph.D. in Computational Neuroscience
  • He became interested in psychedelics via the Global Drug Survey
  • He was doing MDMA research and then the microdosing project came to him

About David

  • He is a medical doctor and works in clinical psychology doing research
  • He does brain imaging and his background has been in addiction, depression and schizophrenia
  • He did his postdoc at Imperial and worked with Robert Carhart Harris
  • He worked in a clinical trial working with people of treatment-resistant depression
  • He is currently working on an online survey for microdosing

Psychedelic Medicine

  • MDMA for PTSD is the most advanced in terms of available scientific evidence for psychedelic medicine
  • There is already a big gap in psilocybin vs MDMA for treatment
  • There isn’t much research on microdosing yet
    • In order to do research on microdosing, you’d have to bring in a ‘patient’ and have them in the lab for many hours at a time, very frequently, and it’s not practical

The Microdosing Study

  • In this microdosing study, they are testing cognitive function
    • The user will have to fill out a questionnaire throughout the duration of the microdose
  • There were a lot of things, very political for the downfall of psychedelic science
  • When the double-blind method was introduced for science, it used methods that would have compromised the ‘setting’ of taking psychedelics
  • There is a manual that the users have to follow for the setup process
    • Its a semi-randomized process where they take the microdose over 4 weeks and it may be either the psychedelic or a placebo
    • It works on a method of a dose hidden in a capsule assigned to a QR code, where the user doesn’t know what they take until the end of the study
  • This is a study inviting people that plan to microdose a blotter based psychedelic or plant-based psychedelics.
    • Its a hands-off study of observation, based on a users own plan on taking the substance

Summary of the Study

The Imperial-Beckley self-blinding microdose study is a new global study on psychedelics microdosing. The study uses a unique ‘self-blinding’ methodology where participants implement their own placebo control.

In the study, voluntary participants microdose on their own initiative, using their own substance, without the study team’s supervision. However, the study team provides a manual that explains step by step how self-experimenters can set up their own placebo control. The placebo control is implemented by placing both microdoses and empty capsules into sealed envelopes, which are then labelled with QR codes and distributed according to a schedule. Participants won’t know whether their capsules contain a microdose or an empty placebo until the end of the study.

The study is run entirely on the internet, therefore microdosers can participate from anywhere in the world, recruitment is now open.

This ‘self-blinding’ design allows the team to investigate whether the purported benefits of microdosing are due to the placebo effect, or the pharmacological action of the psychedelic, which is a critical scientific questions regarding microdosing.

Limitations of the Study

  • Its half-way between a clinical study and an observational study
  • They aren’t sending the users the LSD, they are just providing the platform for the users to share their experience on
  • In this trial, the flaw is that the research team doesn’t know the dose size of the blotter the user takes, it could start as a 100mg, more, less. Its a variable that cannot be controlled
    • The fix would be to have the LSD sent to the lab, tested for dose size, and then sent back to the user (anonymously), but since it’s illegal it cannot be done
    • It’s also hard to determine even distribution of a blotter into microdose size
    • They don’t know if the user is cutting the blotter paper like a pie or in squares
  • Also, because the drug is being bought on the black market, they wont know if there are adulterants in the drug unless the user tests the drug themselves
    • David and Balázs also say that based on current findings, most LSD tested is pure LSD, where a drug like MDMA is more common to contain an adulterant
  • They do have plans to extend the study to include plant based psychedelics and volumetric dosing

What is a Psychedelic Microdose?

  • Psychedelic microdosing is not the same as Pharmacological microdosing
  • A microdose in pharmacological context is 1/100th of a dose, where a psychedelic microdose is more like 1/10th of a dose

Is Microdosing Worth it?

  • People like David Nichols and Ben Sessa think microdosing is pointless
    • It could be that microdosing is a glorified placebo effect
  • Most people who are microdosing have had previous experience with psychedelics
    • People are doing it because they believe there is a benefit that comes from it
  • The placebo control is the most important component of this self-blinded method
  • People say that microdosing stimulates their creativity, but creativity is hard to measure
  • One thing they could measure is personality through a personality assessment
    • One thing that has been studied is an increase in the ‘Openness’ personality trait after psychedelic use
    • The flaw is that a personality test is a person answering questions about themselves

Current Findings

  • The benefit of this study is it doesn’t take people out of their natural, personal setting
  • Based on the feedback already received, the users are getting their guess right only half of the time, on whether it is the microdose or the placebo
  • Just because microdosing may have a placebo effect (the way they feel while taking it) it may actually have benefits (users may be more creative, have better problem-solving skills, etc).
  • Homeopathy is widely believed to be a placebo effect in the scientific community, but the homeopathy is continuing to grow

Setting Up the Study

Links

Self-blinding Microdose Study


About Balázs Szigeti, PhD

Dr. Balazs Szigeti has studied theoretical physics at Imperial College, but turned towards neuroscience for his PhD studies at the University of Edinburgh. His main work is about the behavioural neuroscience of invertebrates, but he has a diverse scientific portfolio that includes computational neuroscience and driving forward the OpenWorm open science initiative. Balazs is also the editor of the Dose of Science blog that is published in collaboration with the Drugreporter website. Dose of Science discusses and critically assesses scientific studies about recreational drugs. Recently Balazs has started a collaboration with the Global Drug Survey to quantitatively compare the dose of recreational users of various drugs with the scientific literature.

About David Erritzoe, PhD

Dr. David Erritzoe is qualified as a medical doctor from Copenhagen University Medical School and currently holds an Academic Clinical Lectureship in Psychiatry at Imperial College London. Alongside his clinical training in medicine/psychiatry, David has been involved in psychopharmacological research, using brain-imaging techniques such as PET and MRI. He has conducted post-doc imaging research in the neurobiology of addictions and major depression. Together with Prof Nutt and Dr Carhart-Harris he is also investigating the neurobiology and therapeutic potential of MDMA and classic psychedelics.

Nathan Sepeda – 5-MEO-DMT Research, Toad Conservation and Proper Facilitation

Nathan Sepeda

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In this episode, Joe interviews Nathan Sepeda, a Research Coordinator at Johns Hopkins. Joe and Nathan cover topics on 5-MEO-DMT research and survey studies, the difference between synthetic and toad sourced 5-MEO-DMT, the sustainability of the Bufo Alvarius toad, and the benefits of a proper facilitator.

3 Key Points:

  1. 5-MEO-DMT is starting to gain traction in the research world. The conversation continues on whether the synthetic 5-MEO-DMT experience is any different from a 5-MEO-DMT experience sourced from the toad venom.
  2. As the popularity of 5-MEO-DMT increases, concerns about the wellbeing and sustainability of the Bufo Alvarius toad also increases.
  3. Proper facilitation has been shown to affect a person’s experience on a substance like 5-MEO-DMT. The use of a practitioner, finding the substance from a reputable source, and integration all play a critical role in the user’s experience.

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Show Notes

5-MEO-DMT

  • Joe found out about Nathan Sepeda and the work being done on 5-MEO-DMT after Johns Hopkins released a poster on 5-MEO-DMT
  • Alan Davis put together a survey about people’s 5-MEO-DMT experiences
  • Half of the use was recreational, and then the other half of survey participants used more of a therapeutic approach set and setting including a sitter and integration
    • The study found that the more structured the 5-MEO-DMT experience was around set and setting, the more often participants reported a more mystical experience as well as a lower likelihood of having a difficult experience
    • The survey only looked at synthetic 5-MEO-DMT
    • Using 5-MEO-DMT from a toad also runs the risk of the other toad venom constituents
  • Joe said the first time he heard about data on 5-MEO-DMT was at the Oakland Psychedelic Science Conference in 2017
    • Stan Grof had a keynote saying that 5-MEO-DMT was the future of psychiatry

Toad Conservation

  • The Bufo Alvarius toad’s population is increasingly declining
    • Joe says he knows someone who lives on the Mexican border in the Sonoran desert, and he would have toads jump into his house all the time
    • He doesn’t even see them anymore
    • Joe also mentions the toads flocking to the UV street lights, and people scooping them up or even running them over
    • “How do we do less harm to living things and treat our environment better?” – Joe

Nathan’s Role at Hopkins

  • Nathan is the Research Coordinator of Psychedelic Studies at Johns Hopkins
  • He works as an Assistant Facilitator (sitter) for the psychoactive drug sessions
  • He is involved in Psilocybin studies (currently the depression study)
  • He says he is grateful to be a part of the research, seeing people change in a matter of days from the help of the substances
  • Nathan has a background in Psychology and Neuroscience
  • Mary Cosimano is the primary facilitator for all of the studies at Johns Hopkins
    • His training consisted of mock sessions, ways to ask/answer questions, and overall hold the space
  • A lot of people will describe their experience being the most spiritual experience of their life
  • Joe asks about upset stomach with synthetic psilocybin
    • Nathan responds saying they ask patients to eat a light breakfast, but he never really sees upset stomach with synthetic psilocybin

Proper Facilitation

  • The use of a practitioner and finding the substance from a reputable source are the two biggest factors in having a great experience, along with integration
    • Nathan says that these findings are preliminary but they are a great start to data on the substance and its use
  • Joe says he is cautious about the religious affiliation people prescribe to their experience with these substances
    • It can get out of hand, there are “shamans” that taze people or throw buckets of cold water on their patients when they are on the substance
    • Waterboarding, sexual assault, all of these things speak to the value of screening practitioners
  • Joe has heard about a facilitator using an extremely high amount of 5-MEO-DMT on his patients, far above the effective dose
  • Joe mentions a story about a “shaman” who was to facilitate a session. The participant thought they were going to do standard DMT, and the shaman gave them 5-MEO-DMT instead (without the users consent)
    • Joe suggests that just because you know a reputable source for a substance, doesn’t mean they are a good facilitator

Final Thoughts

  • People can find information on the study at clinicaltrials.gov
  • People can apply by contacting Nathan’s team directly
    • They will have room for healthy volunteers in healthy volunteer studies in the future
    • They are currently working on “insight surveys” that are surveys asking people about their psychedelic experiences

Links

Hopkins Psychedelic Research Website


About Nathan Sepeda

Nathan Sepeda is an assistant facilitator (or guide) for psychoactive drug sessions and research coordinator for the Johns Hopkins Psychedelic Research Unit. Nathan earned an undergraduate degree from the University of Minnesota studying psychology and neuroscience. His interests in addiction and mood disorders, in combination with the promising research with psychedelics, have led Nathan to Dr. Roland Griffiths’ lab. Nathan is involved in a number of projects investigating the effects of various psychedelic substances, including psilocybin, salvinorin-A, and 5-MeO-DMT.

Dr. Jenifer Talley – Harm Reduction in Clinical Psychotherapy and the Stigma of Substance Use

Dr Jen Talley

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In this episode, Kyle interviews Dr. Jenifer Talley, Psychologist and Assistant Director at the Center for Optimal Living that specializes in harm reduction psychotherapy. Topics include the current stigma of substance use and the benefits of using a harm reduction approach.

3 Key Points:

  1. Dr. Jenifer Talley is a Psychologist at the Center for Optimal Living who practices harm reduction with her psychotherapy clients.
  2. Substance misuse is typically a symptom of a bigger issue. Jenifer uses integrative harm reduction psychotherapy, a model developed by Dr. Andrew Tatarsky that is organized around 7 Therapeutic Tasks to help build safe relationships with her clients in adjusting their relationships with drugs and alcohol and other behaviors.
  3. There is a stigma on substance use, and shifting away from the current model into a harm reduction framework could help users be more receptive to change and healing.

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Show Notes

About Dr. Jenifer Talley

  • Jenifer grew up outside of DC and moved up to the New York area for her internship and was working with female survivors of trauma and substance use at St. Luke’s Hospital.
  • Dr. Tatarsky founded the Center for Optimal Living in 2011 and she joined the team when they opened and is now the Assistant Director.
  • The Center for Optimal Living is known best for their clinical work and trainings focused on substance use and harm reduction.

Substance Misuse

  • Jenifer says that ‘abstinence only’ or ‘abstinence first’ approach doesn’t really work
    • It’s all about determining the relationship the patients want to have with a substance
    • Abstinence can be ineffective at engaging people who may not be ready to embrace abstinence as their goal. It also supports people’s autonomy and right to make decisions about what relationship they wish to have with drugs and alcohol.
  • People really struggle with vulnerability and trauma is a player as to why someone wants to use a substance
    • “Substance use is a symptom of a bigger issue” – Jenifer
  • It’s unfair to ask someone to change without asking the whole system to change

7 Therapeutic Tasks

  • The Therapeutic Alliance – Letting the client know they can trust them
    • Sets the stage for treatment in a way that is non-judgmental, compassionate and personalized. Emphasizing the goals that clients wish to work on vs. having my own agenda.
  • The Therapeutic Relationship Heals – Jenifer says they are sensitive about creating a safe therapeutic relationship with clients
  • Enhancing Self Management Skills – How to better help with coping skills, shifting how people relate to cravings
    • “What’s driving my urge to go for a drink right now?”
    • Loneliness, boredom, and sadness are reasons for craving
  • Assessment as Treatment – What was the craving, how did they respond to that craving, how did they give in to the craving, how did they feel afterward
    • When Friday night rolls around, can the client picture the guilt and shame of Monday morning in that moment?
  • Embracing Ambivalence – The client might have different parts of themselves, one part of them may want to really work on healing and change, and the other part of them might never want to change
  • Goal Setting – helping clients think through bigger lifestyle changes they want to make, such as diet, self-care activities, and specific substance use related goals
  • Personalized Plan for Change – asking people to really evaluate their use and create a realistic and individualized plan for meeting their goals

Substance Use Stigma

  • How do we not be judgmental about someone’s substance use, and care about their safety?
  • Jenifer says she feels very protective about people she works with, and is very sensitive to her clients because of the shame about their drug use

Clients Under the Influence

  • Jenifer asks herself “does this person need medical attention right now?”
  • She had a client that came in intoxicated but they were able to have a conversation still
    • But she didn’t let him go home because of the fact that he drank
    • She gave him food and water and waited until he was able to get home safely
    • She thought about it from a compassionate approach and thought “what is that telling us about his use?” and the next time the client came in they said their drinking was hardly manageable

Harm Reduction Model

  • There is a gap in training as clinicians as providers
  • In the US specifically, the 12 step process and abstinence are used which are a part of the disease model
  • There is a lot of stigma and shame in calling someone an “addict.”
  • The fear about the harm reduction model is that it is thought to lead to decriminalization
  • The other issue is that the harm reduction model is thought to not include abstinence
    • Jenifer says it does include abstinence, she just doesn’t lead with the abstinence approach
  • Kyle mentions that a common thought for clinicians is “How do I incorporate a hard reduction approach without condoning drug use?”

Shifting to the Harm Reduction Model

  • Help clients build a life that they are happy with
  • 3-day training coming up
    • The training goes into the history and why there needs to be a paradigm shift in looking at addiction
    • The second and third days really go into the 7 Therapeutic Tasks
  • Because there is more funding, they are going to offer regional trainings in Florida and will also train the staff at the Department of Health and Mental Hygiene in NYC.
  • The idea of harm reduction might be less appealing to parents, so they really focus on educating parents and teens on harm reduction versus strict abstinence
  • Kyle mentions a statistic he read saying that the older generation’s vice is alcohol and that young adults are using opioids and pills
  • Psychedelic Education and Continuing Care Program is psychedelic harm reduction

Final Thoughts

  • A harm reduction approach is necessary to teach people how to test, it could possibly save lives
  • Families for Sensible Drug Policy
  • We need to re-humanize treatment for users

Links

JeniferTalley

Center for Optimal Living

Check out our online course, “Introduction to Psychedelics”


About Dr. Jenifer Talley

As the Assistant Director of The Center for Optimal Living, Jenifer coordinates clinical services and training activities along with providing individual psychotherapy.Together with Dr. Andrew Tatarsky, she started the first-ever Harm Reduction Psychotherapy Certificate Program. In her clinical work at The Center for Optimal Living, she provides individual psychotherapy using an integrative harm reduction framework where the focus is on developing a collaborative and compassionate relationship with my clients to promote positive change.