#91: 👩🏽 Could MDMA-AT Have a Bigger Impact for Women?
#91: 👩🏽 Could MDMA-AT Have a Bigger Impact for Women?
Women have higher likelihood of PTSD and MDMA-AT could be a breakthrough therapy
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Hey Friends,
Recently, I attended a conference organized by BrainMind, Susan Magsamen & Ivy Ross, the authors of “Your Brain on Art.”
The conference followed their book launch, and I covered their book and the field of Neuroaesthetics in Nina’s Notes #75: Neuroaesthetics: The Beneficial Effects of Art on the Brain.
Nearly every innovator, researcher and founder featured in the book attended and spoke at the conference. It was incredible to be in the same room as these mind-blowing speakers.
For example, I heard first hand the amazing story of how music transformed the management of his schizophrenia, which led founder, Brandon Staglin, to start One Mind and hold annual music festivals in the Napa Valley.
One Mind is putting on their 30th music festival this summer - check it out if you are in the Bay Area.
I hope they make the Your Brain on Art conference an annual event!
💬 In this note:
🤸🏽♀️ Could MDMA-AT Have a Bigger Impact For Women?
📚 Vengeful
⚡️ Dinosaur skeletons for sale
👩🏽 Could MDMA-AT Have a Bigger Impact for Women?
In the U.S., about 6% of people suffer from PTSD and women are more likely to develop PTSD than men.
About 8 of every 100 women and 4 of every 100 men will experience PTSD at some point in their life.
Women are at a higher risk to develop PTSD due to the types of traumatic events that women are more likely to experience, such as sexual assault, compared to men.
Furthermore, gender-diverse and transgender individuals, ethnoracial minorities, first responders, military personnel, veterans and victims of chronic sexual abuse have a disproportionately higher risk of developing PTSD.
Although the selective serotonin reuptake inhibitors (SSRIs) sertraline and paroxetine are FDA approved for treating PTSD, 35–47% of individuals do not respond to treatment.
More effective, therapeutic interventions are needed to address the immense individual, societal and economic burdens of PTSD.
As an alternative treatment to talk therapy or SSRIs, mounting evidence supports MDMA assisted therapy (MDMA-AT) as a treatment for PTSD.
MDMA (3,4-methylenedioxymethamphetamine) is an active ingredient in the party drug commonly known as ecstasy or molly.
In the party scene, people use MDMA to elevate mood and energy levels. It gives a feeling of bonding with others and has some psychedelic effects.
The same effects have been hypothesized to support people with PTSD during psychotherapy sessions, as MDMA makes people more willing and open to sharing and exploring their traumatic experiences.
A pivotal phase 3 study, MAPP1, showed that MDMA-AT was generally well tolerated and met the trial’s primary and secondary endpoints of reduced PTSD symptom severity and decreased functional impairment.
MDMA may have a stronger impact on women
The research indicates that MDMA-AT has a more significant impact on women compared to men.
Studies show that psychoactive effects of MDMA were more intense in women, with women experiencing higher scores for MDMA-induced perceptual changes.
Women revealed they felt more “carefree,” “free of worries and obligations” and experienced “boundless joy” and “comprehensive love.”
Women also experience more thought disturbances than men, including impaired decision making, accelerated thinking, and losing track of one’s thoughts.
In addition, female subjects also had significantly more fear of loss of body control than men.
Women also had significantly increased scores on “visual (pseudo)-hallucinations” while there was no increase in men.
The intensity of perceptual changes in women positively correlated with the dose of MDMA administered.
Furthermore, a study on gender differences on MDMA in men and women found a significant correlation between the dose of MDMA and MDMA-induced anxiety scores in women, but not in men.
Lastly, men showed higher increases in blood pressure than women.
Are the results from the clinical trials stronger in women with PTSD than others?
The second confirmatory phase 3 clinical study, MAPP2, extends the findings of MAPP1 in an ethno-racially diverse population with moderate to severe PTSD.
MAPP2 had ~71% of participants that were assigned female sex at birth, a total of 74 of the 104 participants enrolled in the study. Of the 74 female sex at birth participants in the study, 32 received MDMA-AT.
The primary outcome of the study was measured by a reduction in PTSD symptoms after 18 weeks as assessed by a clinically administered questionnaire, called the CAPS5.
In the phase 3 clinical trial, female sex assigned at birth was associated with a reduction of PTSD total severity after MDMA-AT.
Overall, ~86% of participants in the MDMA-AT group showed clinically meaningful improvement 18 weeks after MDMA-AT.
Of that 86% with meaningful reduction of PTSD symptoms, 71% of study participants no longer met PTSD criteria and 46% qualified as in remission from PTSD.
The research suggests MDMA-AT may be particularly beneficial for women with PTSD, potentially leading to greater symptom reduction, loss of PTSD diagnosis, and remission rates compared to men.
Currently the MDMA assisted therapy (MDMA-AT) clinical trial data has been submitted to the FDA and is going through the review process.
One step in the process is for a panel of experts advising the FDA to review the data and submit their opinion to the FDA.
Despite the study findings, this panel publicly announced in early June that, in their opinion, the available evidence fails to show that the drug is effective or that its benefits outweigh its risks.
They voted 9-2 that MDMA-AT is not effective for treating PTSD.
And they voted 10-1 that the benefits of MDMA treatment don’t outweigh its risks.
While the FDA puts stock in the panel’s advice…
…it does not have to follow their recommendation.
Now we have to wait for the FDA’s decision which is slated to arrive August 11, 2024.
If the FDA approves MDMA-AT, it will be the first new treatment for PTSD in over 20 years.
📚 Book of the Week
Vengeful (Villains #2) by V. E. Schwab
Rating: ★★★★★
I loved Book 1 and couldn’t wait to start Book 2.
Our favorite characters from Book 1, Eli Ever and Victor Vale, are back for Book 2 of the Villains series.
In the first book, A Darker Shade of Magic (Nina’s Notes BOTW #34) Eli and Victor turned themselves into ExtraOrdinaries (EOs) through near death experiences.
After an end to their friendship, the duo part ways, with Eli seeking out other EOs to rid the world of them, and Victor fighting for his life after a resurrection.
Now in Book 2, Eli is confined to a jail cell, and Victor is searching for an EO to cure his pain while simultaneously cutting down any EO in his wake who can’t help him.
All the while a new EO rises to power, Marcella Riggins, who survives an attempted homicide by her husband with an unusually destructive superpower.
Her power, combined with her thirst for revenge, have her in control of the mob almost instantly.
I was captivated by the book and thankful for the fast pace of the story.
Definitely pick this one up (of course, start with A Darker Shade of Magic first) if you are seeking a suspenseful thrilling read for this summer.
Also, this would be a good one for spooky season.
⚡️ Check This Out
Dinosaur skeletons are being sold at auctions at extraordinarily high prices.
Stan, the T. Rex skeleton, became the most expensive fossil ever sold for $31.8m at a Christie’s auction in 2020 — more than 4x the estimates.
That smoked the previous record of the T. Rex Sue, which sold for $8.4m at auction in 1997.
The world’s biggest triceratops skeleton, 66m-year-old Big John, went for $7.7m at a Paris auction house in 2021.
In 2022, Christie’s sold a deinonychus specimen named Hector for $12.4m, more than 2x the estimated price despite only having half its bones.
While dino bones discovered on private land in the U.S. are fair game to sell, these high auction prices are too high for academic institutions to purchase them, and each fossil sold privately limits the number of specimens that paleontologists can study.
Fewer than 20% of T. Rex fossils purchased by private collectors have ended up in a museum, per Business Insider.
Edited by Wright Time Publishing