FDA Acceptance and Priority Review: Lykos Therapeutics' MDMA-Assisted Therapy Breakthrough for PTSD

In a groundbreaking move, the U.S. Food and Drug Administration (FDA) has granted priority review to Lykos Therapeutics' (formerly MAPS PBC) MDMA-assisted therapy for individuals with post-traumatic stress disorder (PTSD). This development not only marks a significant leap in mental health treatment but also holds profound implications for companies like Numinus in the field of psychedelic-assisted therapy. 

Understanding the FDA Priority Review

The FDA's priority review is a special designation reserved for drugs that promise substantial improvements in safety or effectiveness compared to standard treatments. In the case of MDMA-assisted therapy, this acknowledgment underscores the urgent need for innovative approaches to address the complexities of PTSD. MDMA-assisted therapy was only submitted as a new drug application to the FDA by non-profit Multidisciplinary Association of Psychedelic Studies (MAPS) in December 2023.

A Glimpse into MDMA-Assisted Therapy

MDMA-assisted therapy, an important and promising venture in mental health treatment, involves the use of midomafetamine capsules (MDMA) in combination with intentional therapy before, during, and after each medicine session. Based on the data from two published Phase 3 studies completed by MAPS and numerous other trials, MDMA-assisted therapy is a real breakthrough in the treatment of PTSD. 

What This Means for Numinus and the Psychedelic Therapy Landscape

Validation of Psychedelic Therapies

The FDA's early acknowledgment of the potential benefits of MDMA-assisted therapy provides a significant boost to the legitimacy of psychedelic therapies. This is good news that we anticipate will pave the way for broader acceptance and integration of these treatments into mainstream mental healthcare.

Expanding Treatment Options

If (and when) approved, this therapy would represent a monumental shift in the available treatment options for PTSD. Companies like Numinus, already at the forefront of psychedelic therapy, may see expanded opportunities to offer innovative solutions for people suffering from post traumatic stress disorder. 

PTSD, a grave mental health condition stemming from traumatic events, grips approximately 13 million Americans each year. Military personnel have a greater prevalence of PTSD than the general population, however, it may not be as widely known that that the largest cause of PTSD is non-combat-related trauma (e.g., sexual violence, unexpected death of a loved one, life-threatening traumatic event or interpersonal violence). Women and marginalized groups bear a disproportionate burden, underscoring the urgency for inclusive and targeted treatment. With this treatment available, Numinus will be able to provide this option for relief that these people need and deserve across our network of clinics.

Heightened Focus on Safety and Efficacy

The FDA's priority review signals a keen focus on ensuring the safety and efficacy of psychedelic treatments. This emphasis aligns with Numinus's commitment to providing evidence-based and responsible psychedelic-assisted therapy.

Psychedelic-Assisted Therapy Training 

With increasing public awareness and acceptance of psychedelic medicine, our training program is pivotal in preparing professionals to meet the demand for responsible and safe MDMA-assisted therapy. As the therapeutic landscape expands, Numinus-trained and certified practitioners will be ready to integrate psychedelic assisted protocols into their practice. This transformative period presents opportunities for collaboration and cements the role of our training programs in moving this type of treatment forward. Learn more about our certification pathway here.

Looking Ahead

We are deeply invested in the transformative power of psychedelics and are thrilled to learn about the FDAs priority review of MDMA-assisted therapy. Our team wholeheartedly believes this development can and will change lives.

Honoring Veterans and Addressing PTSD

As Veterans Day arrives, it's not just a time for gratitude but also a moment to shine a light on the mental health challenges faced by those who have served in the military. On a recent episode of KSL’s Dave & Dujanovic, hosts Debbie Dujanovic and Dave Noriega delved into the topic of Veteran mental health, particularly post-traumatic stress disorder (PTSD), with Numinus therapist John Ellis.

The discussion opens with personal stories, including Dave's revelation about his grandfather's World War II experience, emphasizing the often unspoken struggles that veterans carry. John Ellis, a therapist with a background in the United States Air Force Reserves, shares insights into the importance of storytelling for veterans and the therapeutic value of sharing experiences.

"A lot of veterans do keep things inside. But they have stories to tell. And when they start to tell them, it does help." John says.

Fostering an environment of connection, empathy, and emotional understanding, the need for vets to share their experiences is paramount. Our collective society's attentive listening becomes pivotal in acknowledging the importance of veterans' narratives. So, what first steps can we take? 

Let’s start with compassion. Creating a safe and supportive environment to empower veterans to openly express their feelings will help them navigate the path towards healing.

But it isn’t all that simple to create this safe space. Veterans face challenges when opening up about the past, particularly the painful memories. These experiences don’t always flow from the memory into a story - they are sometimes haunting, and dig up old wounds. "We need to help them start telling their stories a little bit. And when they do, we need to listen. It does help them, and it's hard to tell them. Even the good ones." John continues to say. Many people feel sensitive about asking questions, fearful of saying something wrong or triggering. However, there is a balance, and approaching the conversation with delicacy, kindness, and respect can make a veteran feel appreciated. Think about starting by saying something like this: “I understand that talking about your experiences in combat can be challenging, but I want you to know that if you ever feel the need to share or discuss anything, I am here to listen without judgment. Your feelings and experiences are important, and if you choose to open up, this is a supportive space. I appreciate what you've done, and I'm here whenever you're ready.”

For veterans, the emotional connection formed through shared narratives can also be built through engagements such as individual therapy, group sessions, or community resources. "There's that emotion and empathy that can be formed in connection. I think that's really where it starts, whether it's in a therapeutic relationship, just one-on-one with a family member, or amongst veterans - combat or otherwise."  John explains. 

When discussing signs of PTSD,  common indicators include flashbacks, hypervigilance, night terrors, existential dread, and fear that can linger, making it difficult for veterans to feel safe. To begin working through these unwanted feelings, starting with the Veterans Affairs (VA) system is always a solid first step. 

The door is wide open at Numinus, where we provide therapy and utilize treatments like ketamine-assisted therapy, known for its effectiveness in reducing symptoms of PTSD and suicidal thoughts. Many Numinus therapists and staff are veterans themselves, and we always do our best to pair vets-to-vets for an added layer of empathy.

At Numinus, we strongly believe in the power of psychedelic therapy. Ongoing research favors ketamine and other psychedelic medicines, such as psilocybin and MDMA, in treating mental health conditions. Numinus is helping carry the torch for this work, alongside and partnered with long-standing companies like MAPS (Multidisciplinary Association for Psychedelic Studies). The promising results from recent studies show psychedelics, when coupled with talk therapy, have a highly positive impact in relief from depression, anxiety, PTSD, and more.   

We really have learned, from the 70s to now. There really is a lot of research and some real expertise – and there are people that really know how to help navigate your experience," John says. "We’re [Numinus] really helping people rewire their brain from that trauma - that medicinal kind of regeneration of neurons that happens during a psychedelic experience.

As we reflect on Veterans Day, let's carry forward a renewed commitment. Acknowledging the struggles of veterans and the importance of mental health, we extend our gratitude and encouragement. Together, let us foster a compassionate environment, embracing the healing potential of both shared narratives and therapeutic interventions. 

If you or someone you know is a veteran facing mental health challenges, remember, seeking support is a courageous and vital step. Your well-being matters, and the journey towards healing is a shared endeavor.

 

World Suicide Prevention Day: Resources

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MAPS Examining the Psychedelic Renaissance - Season 2 Episode 10 with Drs. Reid Robison & Adele Lafrance

Episode 10: Psychedelic-Assisted Psychotherapy for Eating Disorders and Cognitive Behavioural Therapies for PTSD + MDMA

Episode Summary: Hear from the MAPS Researchers. In this episode we will get to hear from some of the leading experts in the field of clinical psychedelic research. Both Dr. Adele Lafrance and Dr. Reid Robison are currently focussed on a study looking at using MDMA to treat PTSD. While Dr. Anne Wagner also has a background investigating Eating Disorders, she will be touching on her work with MDMA + Cognitive Processing Therapy.

Exclusive Post Webinar Sessions:    (Exclusive Post-Webinar Session Details:  Session take place in a private zoom room with the speaker and 6-10 other participants. Limited Capacity. Zoom links sent out the day of the event.  6:30-7:30PM PST, Tuesdays (following the speaker’s episode).  Webinar attendance is not mandatory; however all passes include 1 complimentary ticket to the entire series! 

  • Join Adele and Reid for an Exclusive Q&A. Reid is currently the coordinating investigator for the MAPS-sponsored study MDMA assisted psychotherapy study of eating disorders, and Adele is the clinical investigator and strategy lead for the MAPS-sponsored MDMA-assisted psychotherapy study for eating disorders. This is your chance to meet with the two of them and have all of your questions answered in a semi-private session. To register, see Ep 10Ex: Exclusive w/ Adele & Reid.

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Episode 38: David Treleaven on COVID Trauma

 

"To move through trauma often means going back to what was too much. Often we need to be with someone who is with us saying ‘I’m here. You’re safe. It’s okay to feel it now.’”

In this episode of the Numinus podcast, Dr. Joe speaks with David Treleaven. David is a trauma professional, mindfulness teacher, and educator. He is also the author of Trauma-Sensitive Mindfulness: Practices for Safe Healing. After struggling through symptoms of secondary trauma on a meditation retreat, he developed the Trauma-Sensitive Mindfulness (TSM) approach.TSM helps trauma survivors avoid the risks they face when practicing meditation. TSM has been taught to veterans, prisoners, healthcare professionals, first responders, and many others.

Through workshops and online courses, David teaches mindfulness providers the tools of TSM, so that they can meet the needs of people struggling with trauma. More information on his online training can be found here.

David has worked with organizations like Search Inside Yourself Leadership Institute (developed by Google) and the University of Massachusetts Medical School by bringing them the tools and techniques of TSM to their staff and programs. He is also a visiting scholar at Brown University.

He is the host of The Trauma-Sensitive Mindfulness Podcast. He has had guests on like Sharon SalzbergRick Hanson, and recently Dr. Joe Flanders!

 

In this interview Joe and David explore:

  • Challenges with the definition of the word trauma
  • Is there such a thing as COVID trauma?
  • Why some people are more resilient in the face of difficult experiences
  • Neurobiological models of Post Traumatic Stress (PTS)
  • Diagnosing PTS
  • Approaches to treating PTS
  • The implications of collective trauma from COVID-19

 

Here is more information on subjects mentioned in this episode:

 

More quotes from David from the interview:

“Post-traumatic stress can be the impact of two different impulses acting at the same time.”

 

“Sometimes I think of trauma as us living through impossibility, and then the costs of that.”

 

“The further away I get from academia, I find myself less interested if we count a hundred people and we talk about all of their stories, whether or not we’re going to qualify their experience for being traumatic or not. What I’m most interested in is what, in a very practical way, are going to be the interventions that are going to support this person to have less pain and suffering in their life.”

 

“To move through trauma often means going back to what was too much. Often we need to be with someone who is with us saying ‘I’m here. You’re safe. It’s okay to feel it now.’”

 

“In my experience with people when they’ve really moved through or integrated that trauma is that they’re on the other side of a pretty big emotion or discharge through the body, they say, ‘Oh, it’s finally over. It’s been trapped inside of me for a long time. And now I’m integrating it in a different way.'”

 

Here are some highlights from their conversation:

 

COVID might refer to a specific viral entity, but it means so many other things. And I guess there’s a diversity of experiences that people have had. And I don’t know, you tell me, do we want to talk about–what was your distinction there, like traumatic experiences people have had in the pandemic era or or just like some kind of collective trauma that we’ve all experienced living through this? 

Well, there’s so much to say here. I’ll talk about how I’ll define trauma here which would be a response to actual or threatened death, serious injury or threat to physical integrity. And I think it’s important to at least start here and see if we’re on the same page because trauma as it’s become more of a popular mainstream term has become slightly diffuse.

And I’d say the definition has been watered down and there’s been some concept creep in the humanities more generally around trauma, which yes, again, there’s a double edged sword here. Where it’s great that people are talking about trauma and unhelpful in some ways to just generalize.

So I’d like to talk about trauma as an input or a situation that is a threat to life and limb where our survival and our fundamental safety is on the line. And COVID cuts both ways here, where definitely it has been a significant threat and it has been an actual material threat to family. I mean, people, families, communities or people are literally dying or their well-being has been threatened. And then there’s been a whole range of more generalized threat that people could say has been traumatic.

But I’d actually challenge that where I think it’s actually just been more a challenge in adversity and where it got murky and it was confusing about, ‘Is my life in danger here, even though I’ve been triple vaxxed,’ for example. So there’s a whole other place where trauma has happened. And then I think there’s been a massive period of adversity collectively that we’re trying to sort out and maybe we’ll be talking about it here in the conversation.

 

Let’s come back to that very evocative story about the child that gets pulled out of the way of an oncoming car. That seems like a pretty good example of a threat to the child’s life, their safety and that child’s nervous system probably goes into some kind of fight or flight reactivity. And then if I’m extrapolating a little bit, the mother is basically communicating through her reaction, ‘shut that emotion down.’ And the child is basically saying to themselves, if I want to stay connected to mom here, which feels really important right now because I’m kind of freaked out, I have to put that emotion away, inhibit it in some way.’ That sounds to me like an example or a mechanism around how things get stuck. 

I wonder if you can say more about why would that be in evolution that certain really intense experiences get trapped? And even what the hell does that mean for something to get trapped in our nervous system? Can I know exactly what that means experientially and sort of working with clients?

The metaphor that’s worked for me I learned from Babette Rothschild, who’s a trauma writer. She wrote a book called The Body Remembers. Yeah, all the best trauma books are like, ‘The Body Keeps Score of the Body.’ But she’s great. She’s awesome. When she’s training people around trauma and is trying to capture what you’re saying, what’s the essence of it? Why does that stuckness happen? Like, what’s the stuckness?

She’ll bring a bottle of soda up on stage and she’ll start shaking it up, and she’ll basically be talking about how the stuckness is the cap. And her metaphor is saying, ‘now what would happen if we just open this soda right now?’ And of course, it would fly. It’s too much for someone. So in Babette’s work, it’s been a lot about–and in a lot of trauma work, it’s about kind of cracking that soda top and allowing some of the pressurized gas.

But let’s back that up even further, because I think it answers your question. The reason I think that metaphor works is that when it comes to trauma, like with that child, there is some kind of activation. I said factory loaded some kind of deep survival response, often referred to as fight flight. So the sympathetic nervous system and the autonomic nervous system just hit the accelerator. We have the survival response. We don’t have to think about it. It just happens automatically. Flood of adrenaline pupils dilate to try to protect us. And then that’s the moment that I think you’re pointing to. That gets very interesting.

Why the cap? There’s lots of stories about different mammals who are able to shake and discharge that activation. You know, a classic example is the deer who shakes it off. It gets really frozen and then shakes it off, moves on like nothing happened. But what’s happening for humans?

You gave the example around attachment. I’d say, ‘yes, I’m faced with the choice of either being disconnected from my caregiver, which is fundamentally threatening. So let me basically cap that energy through locking my jaw so I can stay connected.; And then in other situations, there’s a legitimate freeze, the intense parasympathetic arousal sometimes known as tonic immobility. Which will come and cap or trap that activation of fight flight in the nervous system that can’t discharge over time.

So it has deep evolutionary roots about why we had that freeze, for example, playing dead like the possum. If you’re a gazelle, you’re dragged to a cave, you might freeze. The predator thinks that you’re dead and won’t actually attack you. There are many different inherited reasons that we have that–but it can create tremendous amounts of suffering in an ongoing way for people because we can’t uncap that freeze and it gets really frustrating.

PTSD or post-traumatic stress can be the impact of two different impulses happening at the same time. So for example, the impulse to run and the impulse to freeze, they’re both happening. They’re both legitimate survival strategies. And that combination of the two creates that charge. And you could say that stuckness.

And I wanted to link it here to what’s happened to a lot of health care workers or even family members. Where I heard stories of people saying I was on one impulse was to hold the line around safety in hospitals around who could come in and out of a ward, for example. And then there’s an equal impulse to, of course, let a family member come and be with someone, that loved one or a family member. And so it creates these impossible situations.

And so sometimes I think about trauma as us living through impossibility. And then the costs of that.

 

I think that I probably learned this vocabulary from you, but maybe I can just ask you, describe it, this notion of like pendulum motion. And there’s another term that I find really useful, like titration. 

Titration?

Exactly. I think these are great tools for people to know. Can you describe those? 

Yes, it doesn’t come from me, but Peter Levine. It comes from Somatic Experiencing, which is a really popular psychotherapeutic approach to trauma or healing. And I don’t receive any money for that. I just trained in it a long time ago and the core principle–this actually gets right back to the soda bottle or the pop bottle.

So imagine that bottle of carbonated water being shaken up, and you could think of that as a traumatized system that there’s a tremendous amount of sympathetic activation fight flight in the container. So the accelerator slammed the ground. But there’s also tonic immobility. So it’s capped and that if you imagine the feeling of the accelerator and the brakes slammed down, that’s often what trauma can feel like or post-traumatic stress. It’s really painful, uncomfortable, and dysregulating.

So the idea behind pendulation and titration in this work around trauma–the idea is you’re going to pendulate your attention, so basically go back and forth between areas of where you feel more trauma and areas where you feel more resourced. And in doing so, you’re doing what’s known as titrating. Which is actually an old concept in chemistry where you’re opening the soda bottle, but only to the degree that a little bit of the carbonation is released and then you’re turning it back.

If you opened it all at once, that’s not titration. It’ll cause an explosion. Someone gets flooded. It’s too much. And we all know this. I think intuitively that we can take only so much until we need to take a break because our systems can’t tolerate it all at once. So the essence of a lot of trauma work is to go back and forth in order to titrate and not have it over, not have trauma overwhelm.

 

I wonder if you’d agree with this statement that at least this might be just one among many qualities. But this is the quality or the expertise of a trauma therapist that might be sensitive to the pace and to not go at it full speed right away because one has to work very carefully with that limit. And if you went to a therapist that doesn’t have that training, they might not know how to work with that. Is that a fair statement? 

That is the essence to me of trauma training. That is why one would train to know how to work with a combustible process. It’s because more is not going to be better when it comes to working with trauma.

Let me give an example of that. So I was trained as a somatic therapist where the main question I had was, ‘Where do you feel that in your body? It’s all I had. I was like, ‘Well, where do you feel that?’ And if you just keep driving someone towards intensity to your point, that actually can be too much for them. Now that can be confusing because when you’re working in any kind of mental health work, I think when you see emotion, you think you’re doing a good job. Someone’s crying. I’m like, ‘I must be doing something right.’ And then I’m trying to amplify it because I think we’ll go deeper. ‘That’ll be great.’ And sometimes that’s true.

But when it comes to trauma, right to your point, it’s not. It’s that you need to have a more nuanced approach and you’re learning to track someone’s mind and body in a really nuanced moment to moment way.

 

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Episode 37: MDMA and Couples with Dr. Anne Wagner

 

“I envision a day where people would be able to choose to do MDMA-assisted psychotherapy in a safe context to be either able to heal from something together or to grow together, and to support the relationship.”

In this episode of the Numinus podcast, Dr. Joe speaks with Dr. Anne Wagner. Anne is a Toronto-based psychologist and couples therapist, a researcher studying MDMA-assisted therapy, and the founder of Remedy Centre. Remedy is a social venture that provides individual, couples, and group therapy and reinvests the profit from these services into the Remedy Institute, which is “a new charity focused on supporting mental health innovation & research, including with psychedelics, training for aspiring mental health professionals, as well as low to no-cost therapy services for marginalized communities.”

She is the principal investigator on a pilot trial studying the impact of MDMA-assisted Cognitive Processing Therapy (CPT) on PTSD and is planning a study that will examine the impact of MDMA-assisted Cognitive Behavioural Conjoint Therapy (CBCT) on PTSD.

If you’d like to donate to the Remedy Institute, please check out: canadahelps.org/en/charities/remedy-institute

Dr. Joe and Dr. Wagner spoke about:

 

Here is more information on subjects mentioned in this episode:

 

More quotes from Dr. Anne Wagner from the interview:

“We’ve been doing the first trials that have been anything other than the inner-directed supported approach. So there’s a lot to ask, and a lot to investigate.”

 

“​​Not only does bringing someone along with you on your healing journey provide support, but it also provides the partner with their own support and healing.”

 

“It’s been really interesting seeing folks work with MDMA to help as a catalyst for that meaning-making process.”

 

“People take turns of who is struggling and who is okay. And that can be something that is really nice where they learn to ride the waves of that together.”

 

“I really try to help people frame their ideas around not expecting to have an expected outcome.”

 

Here are some highlights of their conversation:

Before we get to the trial that you’re planning, I want to ask you a quick one about the study going on right now. What’s interesting is that you described it as like a meaning making framework and so it’s very cognitive. And the trends and the buzz and all the excitement is around relational therapy, somatic therapy. Like these are the things that are bubbling up for me in terms of what approaches are being used in psychedelics. And this is a very cognitive approach. 

I’m just curious how you think about that in the sense that I don’t know how many times I’ve heard like, ‘well, you can’t just do like cognitive therapy with someone doing MDMA. It’s just not somehow adequate to touch the depths of the experiences people are having.’ So just really curious about your thoughts there.

I respectfully disagree with thoughts that are the impressions that are there around it. And I think it’s partly because of the–it is possible to do cognitive therapy in a way that feels stiff and disjointed and doesn’t go into the depths. But I think if you’re delivering it in a way and working with the participant in a way that’s bringing in all of their experiences, it’s an incredibly rich way of working with everything that comes up.

And so of course, like even though it’s cognitively focused in terms of meaning making, we’re working with emotions, we’re working with sensations, we’re working with behaviours. It’s not excluding any of those components.

And it’s helping folks not only work with what has happened and the interpretation of what’s there, but also what’s happening now and what’s going into the future. It allows for the sense of my everyday life. ‘Oh, this is how this is going to change and this is how I can implement it.’ And that we find really effective.

It’s been really interesting seeing folks work with the MDMA sessions to help as a catalyst for that meaning making process because there is so much meaning making that happens in the MDMA sessions. And you’re just providing a bit of a frame to help that continue afterwards. So I always think of that as the catalyst.

 

I came up with this analogy the other day that has stuck around for me. I’d be curious if you’re on board with it. If you get a bacterial infection like strep throat or something. Your body could probably heal it, right? No problem. You’re healthy, you have a functioning immune system. It might take a little bit longer and you may not feel so great, but you can probably handle it. Or you can go to the doctor and get a medicine to help your body heal some health problems. 

And I’ve started to think about maybe psychedelics in general or MDMA for couples where there may be something broken or something challenging happening in the couple that if they were to go for walks and go out for dinner and whatever, take the time to invest in themselves, they could probably heal through it. But MDMA is a medicine that might help speed up or deepen that process in some way. Which means that there may be situations in some future state where you can go to the clinic with your partner and get MDMA couples therapy to accelerate healing that might otherwise happen organically. Your thoughts on that? 

Yeah, I do think that that’s a possibility. I think the medicine analogy is an interesting one because I actually had this conversation earlier this week with someone who was raising the point that I think sometimes people think that the taking of the pill is the thing that will cure them and be helpful. And it’s actually nothing. Like as far as we know, there isn’t anything inherent yet in the taking of that pill with MDMA in particular, that would have that effect.

It’s the psychotherapy, the psychological process that happens after that would create that shift. So I do think, though, that the experience, the MDMA session as being something that can help speed it up. It can help you do a good piece of work, a good chunk of work in a quick period of time. That’s true. And so that’s where I think it could exactly be really helpful.

I envision a day where people would be able to do that and choose to do that as something to either–with support and in a safe context–be able either to heal from something together or to grow together in a different way and to support their relationship. That would be fantastic to have that capability and that possibility.

 

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Everything You Need to Know About Cannabis and Mental Health

“We’re just at the beginning,” Dr. Claude Cyr told Dr. Joe on episode 10 of the Numinus podcast. He was talking about what we know about the potential positive and negative impact of cannabis on mental health.

Dr. Claude Cyr is a family physician who has been practicing medicine for over twenty years. He judiciously prescribes medical cannabis to his patients.

In 2015, the Prime Minister of Canada, Justin Trudeau, announced his intention to legalize cannabis. One year later, Claude founded Doctors for Responsible Access to bring the medical community into the conversation on legalization.

Now with the end of prohibition in Canada and in a few states in the US, the doors have opened for researchers. We’re just at the beginning of understanding the potential uses and misuses of cannabis.

But what exactly do we currently know about cannabis and its impact on mental health? In episode 10 of the Numinus podcast, Dr. Cyr shares with Joe his reservations and hopes for cannabis and its potential treatment for mental illness.

Let’s dive in.

Note: If you would like a more in-depth discussion of medical cannabis, Dr. Cyr will be running a one-day training on cannabis and mental health for healthcare professionals at the Numinus clinic on November 29th, 2019 called “Cannabis Safety – a primer for health professionals.”

The Current State of the Science on Cannabis

“We know about one percent of what the therapeutic potential of cannabis is.”

Dr. Cyr told Joe that when he was attending medical school in the 1980s, we didn’t even know that the endocannabinoid system even existed.

Now we know that there are over a hundred cannabinoids in cannabis. Only two of which have been adequately researched: CBD and THC. And there are probably a dozen or so cannabinoid receptors. Only one of those has been studied to a significant degree: CB-1. These receptors are found all over the body: in the brain, the liver, the lungs, the kidneys, etc. So why is that important?

By isolating and synthesizing each individual cannabinoid, and we can study the interaction they have on each receptor. We can also combine them in different concentrations and see if that also has a particular effect. The possibilities are endless.

Anxiety

Many people with anxiety self-medicate using cannabis. Dr. Cyr said, in short, that this was a bad idea. A short period of euphoria is followed by a depressed mood, elevated anxiety, and withdrawal symptoms. Also, people who self-medicate using cannabis use strains with too much THC and not enough CBD.

However, according to Dr. Cyr there is a possibility that cannabis may be very beneficial for people with anxiety. We just need more studies in order to determine which strain and which dose would have the most benefit.

Depression

Two studies came out a couple of years ago. One study followed people with depression who self-medicated, and another followed people with depression whose cannabis use was prescribed and monitored by physicians.

The outcomes were unfavourable for those who self-medicated. However, patients who were monitored by a medical professional fared better.

One possible explanation for this difference in outcomes is that, according to Dr. Cyr, those who self-medicate tend to consume far too much THC (sometime up to a hundred times the dose that is necessary) and not enough CBD.

Interactions with Antidepressants

At small therapeutic doses of THC, the interactions in the liver have not been shown to be significant, Claude told Joe. However, no studies have been done at much higher doses.

PTSD

“When cannabis is used in palliative care, it does have a tendency to make people forget. What we call aversive memory extinction.”

Dr. Cyr told Joe that the average dose of cannabis used by veterans in Canada is “two to three grams a day.” It is an extremely popular form of self-medication for those that suffer from PTSD. And there might be good reason for that.

“When cannabis is used in palliative care, it does have a tendency to make people forget. What we call aversive memory extinction,” Dr. Cyr said. For example, if patients undergoing chemotherapy are using cannabis before, during, or after treatment, “it’ll help prevent that memory from sticking,” he continued. According to Dr. Cyr, preventing those memories from being hard-wired can be beneficial in certain circumstances.

But is it effective long term? “If you look at certain studies, sometimes the outcomes are worse. If you look at other studies, patients claim that it makes them feel better than all the other medications that they have been using up to date,” Dr. Cyr said.

But again, Dr. Cyr said that there is a lot more research that has to be done.

The Risk of Psychosis

“That’s a huge risk right now.”
Studies have shown that there is a threshold of THC concentration where the risk of psychosis increases significantly. Dr. Cyr warned that people can very easily take “a huge dose of THC in a very short period, which was something probably more difficult to do 30 years ago.”

Two studies were done this year with just over 10,000 students, 4,000 in Montreal and 6,000 in Finland. They examined the link between psychosis and cannabis consumption. The researchers found that the risk for developing psychosis is extremely high in teenagers who had premorbid conditions and had consumed cannabis. But the risk also increases in those without premorbid conditions, just to a lesser degree.

Dr. Cyr warned that teenagers need to be extra careful. “Even if you have no predisposition to schizophrenia, if you start consuming cannabis as a teenager, you may become schizophrenic. And that would never have been your trajectory in life.”

Dr. Cyr added that it is probably dose related, as in a high concentration of THC will likely increase that risk. However, including a higher concentration of CBD may help reduce that risk, but more research is  needed to confirm this.

So do we stop all teenagers from consuming cannabis? Dr. Cyr says no. “We may have to put up with a certain amount of risk.” Dr. Cyr added, “but if we can prevent the high risk teenagers from consuming early, promoting the importance of CBD, and therefore reduce the harm collectively, I think that’s something that’s more realistic than just saying, ‘Just say no.’”

Addiction

“If it causes euphoria, if it releases dopamine, it’s addictive.”

However, Dr. Cyr adds, when compared to other drugs like cocaine or nicotine, the rate of addiction is much lower. The addiction rate with cannabis is around 9%, compared to cocaine, which is around 20%, and nicotine, which is around 30%.

The problem is that in “young people addiction is much higher than in adults,” which Dr. Cyr said is around 16%. He warns that “there is something with the teenage brain and cannabis, which is different than the adult brain and cannabis.”

Cognitive Functioning

“People who consume cannabis containing only THC, have trouble with memory, attention span, and concentration,” Dr. Cyr said. However, the good news is that after around 30 days of abstinence, most of these symptoms gradually go away. But Dr. Cyr warned that problems with attention may persist for longer.

Motivation

This is a controversial issue according to Dr. Cyr.

He said that some scientists and doctors believe that while under the influence of cannabis complex tasks might become more difficult to perform since it has an impact on executive functioning. “So [cannabis users] might stop doing complicated things like studying for example because it requires too much mental effort,” he told Dr. Joe.

Sleep

Cannabis is a very popular sleep aid. However, does it produce restful sleep? Dr. Cyr says it depends. According to some, it does, but there hasn’t been a lot of studies. Dr. Cyr also added that “CBD may cause insomnia.”

For his patients, if they haven’t responded to any other medication, he would prescribe synthetic THC. In some of his patients, it finally permitted them to sleep. But Dr. Cyr only prescribes cannabis as a form of last line of defence.

Some doctors argue that cannabis is safer than other sleep-aids like valium and that they rather prescribe it as a first line of defence for people suffering from insomnia.

. . . . .

There is so much more to be discovered about cannabis, whether about its positive or negative effects. And according to Dr. Cyr, we’re at the very beginning. With the end of prohibition in Canada, doors for researchers have been wide opened. So for now, we’ll have to wait, and perhaps we might have to wait awhile.

“We’ll talk in 5 to 10 years,” Dr. Cyr told Dr. Joe.

And we’ll be listening.

Episode 4: Trauma-Sensitive Mindfulness with David Treleaven

I am really excited to share the conversation I had with David Treleaven on the podcast today. David is quickly becoming an important figure in the mindfulness community, especially since the release of his book Trauma Sensitive Mindfulness, which we will discuss at length. He offers some fascinating insights on the intersection of mindfulness and trauma, two topics that seem to be on everyone’s mind these days.

For those you that haven’t heard of David, he is a writer, educator, and trauma professional living in the Bar area, whose work focuses on the intersection of mindfulness, trauma, and social justice. He received his master’s in counseling psychology at the University of British Columbia, and a doctorate in East-West psychology from the California Institute of Integral Studies. He is currently a senior teacher with Strozzi Institute, which helps leaders embody skillful action, and with generative somatics, an organization that integrates personal and social transformation. He is busy gearing up for a series of workshops on trauma-sensitive mindfulness, including at the Center for Mindfulness in Medicine, Health Care, and Society at UMass Medical School and of course at MindfulnessMTL.

We had our conversation about a month before he is set to arrive in Montreal for the event. It’s called Mindfulness Growing Pains and features a public lecture about research on “Meditation-Related Challenges” and a 2-day training for mindfulness and meditation teachers on “Working Skillfully with Meditation-Related Changes.” David is one of 3 presenters and MGP. I spoke to the other 2, WB & JL in episode 2 of the podcast which can be found on MS website. mMTL is a not-for-profit community initiative I co-founded in 2015 to bring together mindfulness practitioners, teachers, health-care professionals in Montreal. All the information is available at mindflunessMTL website and Facebook page.

You can find David online on his website and Facebook page. You can find updates from me on Facebook and Twitter.

David is deeply passionate about the work he is doing and it comes across clearly in the discussion. He is also incredibly knowledgeable and generous provide lots of interesting information, stories, and practical recommendations.

We talked about:

The basics about trauma and how mindfulness can help with trauma recovery. We also talked about some of the risks involved in using mindfulness unskillfully with trauma survivors. The was a fairly long discussion of clinical issues in the trauma mindfulness intersection, including an analysis of a recent clinical experience of my own. And we spent some time unpacking David’s claims that trauma is inherently political and that mindfulness teachers ought to develop greater sensitivity to the social and political context of trauma.

 

Here are some highlights:

5:57

DT: The story of how I got here is… It’s a long one and I’ll give you the headline version. I grew up in Toronto, I was a meditator there and I had a pretty long practice. I really took myself pretty seriously in my early 20s, really got into it.

I had an experience on a retreat. I was in a longer-term retreat, and I had an experience of really dissociating from my body at the time. I was deep in practice, I had a day or so of not being able to really feel my feet on the ground. I went to the teachers at the time and received mostly what was a basic instruction of trust that, and take it back to the cushion. That’s what I did, I was a really earnest meditator. Took it back, but then when I was at the other side of a retreat, I realized the retreat had really ended up being dysregulated for me. I started talking to people about what had happened on retreat and it actually led to this intersection of mindfulness and trauma. Which was surprising to me, I didn’t feel like I had necessarily a history of trauma in my past, but for reasons I get into in the book, it actually made a lot of sense. I ended up doing a dissertation on the topic of, really what’s the intersection of mindfulness and trauma. The dissertation defense got recorded and the video went “viral”. I put that in air quotes because as much as a dissertation on meditation and trauma could go viral… A couple thousand people saw it, including Willoughby Britton from Brown University who you had on the show and on the podcast. Her and I started to get into a collaboration and a conversation.

11:58

DT: What came out of this work was actually realizing — and I get going on this more in the book — is that the years of work I had done working with sex offenders and being exposed, over and over again, to some really traumatic stories, was creating some tertiary or secondary trauma. I was having some symptoms of having nightmares and actually some uncontrollable sensations and that’s what was popping up on retreat for me. So this work really helped me see “Oh my gosh, okay well, trauma actually holds some relevance for me.” That’s what was showing up on retreat for me.

16:53

JF: I wonder if we can kind of backup a step and kind of start with the basics. There may be many people are familiar with somatic experiencing or trauma in general, but want to make sure we’re all on the same page and we can kind of set the foundations with some basic stuff.

For example, what is trauma? What are you referring to when you use that word? It’s so widely used, I think there’s an increasing sensitivity to it and an increasing interest in understanding more about it. What exactly do you mean and what are we talking about?

DT: So trauma is an extreme form of stress. It’s a term that we tend to reserve for the worst things that can happen to us, as humans…

You know, I actually was just on a plane and watching Van Jones on CNN. I was just browsing through the news and Oprah was on CNN. So here are these two, you know, pretty big celebrities at this point, who are really in the news and they were both talking about trauma. I thought “Wow this is this is really starting to come to the fore.”

I’d say in part the reason that’s happening is because of all the organizing happening these last four years: Black Lives Matter, the #MeToo movement… I think trauma is just baked into these movements. I’m glad it’s coming to the fore and I think it’s such an important conversation.

This other part is, I really appreciate you saying, “Well what are we talking about?”, because trauma can also… We don’t want to water it down.

I want to say to your listeners right upfront, trauma is not just a negative emotion. It’s not just a really really bad feeling. It’s actually this very particular intersection of a lot of different psychological, neurological mechanisms happening.

I do want to define it right now and say, as I understand trauma, it’s any event, or a series events, that’s stressful enough to leave us feeling helpless, frightened, overwhelmed, and profoundly unsafe. That’s the terrain we’re in with trauma. This could be witnessing or experiencing violence, or in a serious accident, being targeted by oppression… Research says, you know, 90% of us will be exposed, or will experience traumatic event in our lifetime.

22:10

JF: What is your take on how mindfulness is currently being used to help support trauma recovery?

DT: This was one of the primary motivations of writing the book. It was to support, well really to challenge the idea, that mindfulness based interventions or mindfulness practices, are necessarily a panacea to all problems.

My experience early on in the research was, there was a number of people who were making a jump — and this happened, you know, in your interview with Willoughby and Jared. People were making a leap and saying, well, mindfulness is being empirically shown to reduce stress, so then, it would hold that, when it comes to traumatic stress, mindfulness interventions would be helpful.

In my research and experience, that wasn’t actually the case. It was for some people, and others not. That was the frame of the book, it was to say, mindfulness can both help or hinder trauma survivors.

And to your point, really I think the most important thing for any of us that are offering mindfulness instruction, or interventions, is just to be cognizant of the fact that it’s not a panacea, and that we don’t necessarily know best.

To me that’s where there has been, at times… It’s to really try to push against — I don’t know if I’d call it “arrogance” — the sense of like, “we can do no wrong”. I think that’s the first to your points. That’s just the first, laying the groundwork of saying, if we can go into the conversation about how mindfulness is being used with survivors — in a complex way that’s nuanced — then, we’re already ahead of the game, because I think, it’s deeply subjective.

What has been happening in the research is, this notion that mindfulness can enhance self-regulation. That can be actually profoundly beneficial for people who are experiencing post-traumatic stress, and who are actually dysregulated in their bodies and their minds.

When we talk about self-regulation, we’re talking about the ability to regulate one’s attention, regulate emotions, and also be a tune with one’s body, this is all so helpful.

26:51

JF: Right. So, what’s missing here… Why do we need to improve our sensitivity? What’s the danger?

DT: That’s also a great question. The basic argument that I’m making — and I want to know what you think of this, or your experience is, working with clients and students — is that: Imagine for a moment, that you’re someone who’s experiencing symptoms of post-traumatic stress. That could be flashbacks, that could be… At any point, you could be flooded by sensations that are profoundly disregulating. Imagine that’s your way of being, that’s it, that’s how you’re moving through the world.

And then you come into a contemplative environment, and you’re asked to pay close and sustained attention to your present moment experience. Now that can be… Again, that’s a huge shift for a lot of people to make. And I think it can be very very helpful and often is for a lot of people.

But there’s this potential pitfall, where if someone is attending to what’s predominant in their field of awareness, and what that is is a flashback, or the feeling of one’s got clenching, or legs tensing, you know, of symptoms of trauma.

That can actually end up exacerbating the symptoms and have someone left kind of worse for wear. What’s challenging inside of a contemplative environment is, you don’t always know, as the teacher, how everyone’s doing. You can’t always see… You can’t check in with necessarily everyone at the end of the class. So people can end up falling through the cracks.

30:32

JF: How do we process this very fine line between, when it’s okay to turn toward and be with, and when we need to go seek safety and stability and grounding? How would you recommend people work with that, walk that line?

DT: Joe, that’s the million-dollar question right? It really is. That is the question.

My recommendation, when we’re in this territory, in this particular issue, is for people to stay in that question. I really think that’s the path. A willingness to really stay awake.

Again, speaking to folks who are offering mindfulness interventions inside of their clinical work, or as mindfulness teachers, or for those listeners who are practicing, but especially for those who are in a position of power and authority.

To me there’s a responsibility in that, to stay very live, and very current, and very subjective, with the people that we’re working with, to be in that question you’re asking. When does leaning in to practice actually support and alleviate suffering? I’ll put it that way. And when is it exacerbating symptoms?