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LSD Is on Deck As New Treatment for PMS and PMDD

MindBio Therapeutics is launching a study to find out if LSD can be a tool for improving the challenges of women's moon cycles.

DoubleBlind Mag

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DoubleBlind // News // Science

We’ve all heard about the studies looking into psychedelics and mental health. But what about using psychedelics for women’s health issues? As in, specifically working with psychedelics to treat the hormonal discomfort of a woman’s moon cycle? If you’re a bleeding psychonaut, you probably have anecdotal data on how this works (the answer is well, in case you didn’t know, and for more than just moodiness). Now, a biotech firm is aiming to publish hard data on this subject. 

MindBio Therapeutics Corp. recently announced that it was approved for two women’s health trials to use MB22001, which is basically designer (read: pharmaceutical) LSD. The first is an open-label trial to test menstrual cycle effects and tolerance to MB22001 microdosing in healthy people with a menstrual cycle. The other study is a randomized, double-blind, placebo-controlled trial with parallel groups of individuals with Premenstrual Syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD), who will be microdosing MB22001.

The firm describes MB22001 as a “proprietary and self-titratable form of LSD intended for safe at-home microdosing” that will be used in two clinical trials. One of which will be to look at how acid impacts PMS and PMDD.

“The trials in women’s health aim to address a huge unmet need in effectively treating Pre-Menstrual Syndrome (PMS) and Pre-Menstrual Dysphoric Disorder (PMDD) without the effects of anti-depressants and the combined oral contraceptive pill often used in treatment,” the company said in a press release.

READ: Microdosing LSD: Could it Change Your Life For The Better?

Benzinga reports that MindBio is investigating to see if MB22001 can be used during specific phases of the menstrual cycle, with targeted dosing to alleviate challenging mood symptoms.

Their thesis is based on three main facts. One is the mood-elevating effects of MB22001, which has been demonstrated in other Phase 1 trials by MindBio. The second is MindBio’s Phase 2a open-label trial in patients with Major Depressive Disorder that shows long-term improvements in mood. Third is reports in the “grey literature” (or anecdotal reports) of people self-medicating for PMS and PMDD taking microdoses of LSD.

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“Premenstrual syndrome (PMS) is estimated to affect ~25 percent of all women who menstruate – equivalent to 956 million women worldwide. A particularly severe form of PMS is termed premenstrual dysphoric disorder (PMDD), which affects 3-8 percent of women who menstruate. Current treatments for these issues are selective serotonin reuptake inhibitors (SSRIs), given either continuously or daily during the luteal phase of the menstrual cycle. While SSRIs can be effective for some with PMDD, approximately 40 percent of women with PMDD do not respond to SSRIs, and common side effects of SSRIs when used for PMDD include nausea, decreased energy, somnolence, fatigue, decreased libido, and sweating.”

The company says it now has several Phase 2B clinical trials in progress beyond the study on women’s health and is “achieving a series of world firsts,” according to its press release.

In May, MindBio said it plans to quickly present secondary data relating to its recently completed Phase 2A trial of MB22001 in patients with Major Depressive Disorder. “The Company has already met its primary end-point using the global standard Montgomery-Asberg Depression Rating Scale (MADRS) to show a 60 percent drop in depressive symptoms and 53 percent complete remission from depression by week 8 of treatment,” the company said in the release.

“The secondary data presentation will report on post treatment effects, using the MADRS and several other vital clinical scales for measuring the effects of MB22001 on each clinical trial participant’s mental health. The readouts are important to understanding the full impact on patients of this novel medicine and, if the results continue to be positive, strengthening the position of this drug as it progresses towards Phase 3 clinical trials.”

MindBio describes itself as a pioneer in clinical studies on the microdosing of psychedelic medicines to treat various conditions, including depression, anxiety, PTSD, panic disorder, chronic pain, and opiate addictions. The company invests in clinical research to “discover potential new treatment options, and we aim to create novel medicines and treatment regimes from breakthrough microdosing studies.”

READ: Even Small Doses of LSD Can Expand Consciousness

MindBio has spent all of 2024 running its clinical trials using its patented form of LSD. It says that in all of its studies, participants “will be randomized to receive psychotherapy alongside doses of either an LSD microdose or placebo.”

It’s likely that the study looking into the effects of LSD on PMS and PMDD will fare well, considering that LSD and other psychedelics, like mushrooms and ketamine, can treat depression and anxiety and uplift moods in specific populations of people.

But this whole thing about MB22001 being “proprietary” and designed for “safe at-home microdosing” is a bit suss. It implies that regular ol’ LSD—the accessible acid—isn’t safe to microdose at home, which is a recurring narrative of the “psychedelic renaissance” that makes me rage into a blackout. Microdosing LSD at home is the tried and true way. Don’t let a biotech firm—building a study on anecdotal data of microdosing normal LSD at home—tell ya differently.

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DoubleBlind is a trusted resource for news, evidence-based education, and reporting on psychedelics. We work with leading medical professionals, scientific researchers, journalists, mycologists, indigenous stewards, and cultural pioneers. Read about our editorial policy and fact-checking process here.

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DoubleBlind Magazine does not encourage or condone any illegal activities, including but not limited to the use of illegal substances. We do not provide mental health, clinical, or medical services. We are not a substitute for medical, psychological, or psychiatric diagnosis, treatment, or advice. If you are in a crisis or if you or any other person may be in danger or experiencing a mental health emergency, immediately call 911 or your local emergency resources. If you are considering suicide, please call 988 to connect with the National Suicide Prevention Lifeline.

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