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Biotech Company Seeks FDA Approval For Psilocybin-IBS Treatment

May 26, 2023 Published by

Tryp Therapeutics announced on Wednesday that it had “submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its planned Phase 2a clinical trial investigating the effects of psilocybin-assisted psychotherapy in the treatment of patients aged 21+ suffering from Irritable Bowel Syndrome (IBS) at Massachusetts General Hospital (MGH).”

The Canadian company said in the announcement that the “planned open label study in collaboration with Harvard Medical School/Massachusetts General Hospital will evaluate the effect of psilocybin-assisted psychotherapy in patients with treatment-resistant IBS who experience chronic abdominal pain and other debilitating gastrointestinal symptoms.” 

“Many of these patients also suffer from fibromyalgia, anxiety and fatigue. The primary efficacy endpoint of the study will be improvement in abdominal pain. The proposed study will also explore changes in brain connectivity and responses to pain at baseline and at four weeks, six months and twelve months post the psychedelic drug sessions, along with numerous other secondary endpoints,” the announcement said. 

“Tryp and our collaborators at Harvard/MGH believe there is tremendous potential for the treatment of debilitating IBS symptoms by utilizing the combined administration of psilocybin and psychotherapy. The clinical study will examine how psilocybin-assisted psychotherapy may alter brain networks involved in chronic abdominal pain and gastrointestinal-specific anxiety in patients with IBS to improve their symptoms. Submission of IND 163994 is an important step in advancing our program,” said Jim Gilligan, the chief executive officer of Tryp Therapeutics.

Gilligan told Green Market Report that the “most important thing is a clinical data – to be able to not just assume or hypothesize that we’re going to have a benefit, but to actually demonstrate that we can do something positive for patients.

“We’re looking at things a little bit differently than the big guys, looking at unique areas where we can have first-mover advantage. But we’re judicious in selecting areas where we really think that we’ll have a positive outcome,” Gilligan said.

According to Green Market Report, Gilligan “likened the planned administration of psilocin to the work of anesthesiologists.”

“Using an IV to induce and subsequently awaken the patient from the psychedelic state, the approach might also allow for the use of serotonin antagonists to terminate the psychedelic experience, if necessary,” the outlet said, which noted that TRP-8803 will be “central” to the company’s approach to the therapy.

TRP-8803 is “Tryp’s lead program,” the company says, describing it as “a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe.

“The Company has an ongoing Phase 2a clinical trial for the treatment of Binge Eating Disorder at the University of Florida, an upcoming Phase 2a clinical trial with the University of Michigan for the treatment of fibromyalgia and a planned Phase 2a trial for the treatment of irritable bowel syndrome at Mass General Hospital, all of which are utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate efficacy in these indications. Where a preliminary clinical benefit has been demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin) which has the potential to further improve efficacy, safety and patient experience,” Tryp said in Wednesday’s announcement. 

The post Biotech Company Seeks FDA Approval For Psilocybin-IBS Treatment appeared first on High Times.

Study: Personal Psychedelic Use Common Among Therapists

March 1, 2023 Published by

Therapists who administer psychedelic treatments to patients apparently like to use psychedelics themselves.

That is the chief takeaway of a new study published in the journal Psychedelic Medicine, revealing that “Personal experience with psychedelics was notably common in this sample of psychedelic therapists.”

The findings, the authors of the study noted, are “the first to delineate the personal use of psychedelics among professionals and can inform a pressing debate for the field.”

That psychedelic therapists use psychedelics might seem like a “dog bites man” caliber headline, but as the authors noted, an “emerging controversy in psychedelic therapy regards the appropriateness or necessity of psychedelic therapists having personal experience using psychedelics themselves.”

“Although there are a number of potential advantages and disadvantages to personal use among psychedelic therapists, no studies to date have measured their use or other aspects of their training,” they wrote. 

For the study, the researchers said that they “broadly review[ed] the literature on experiential learning in psychotherapy and psychiatry as well as the history of personal use of psychedelics by professionals,” and then reported “on the results of a survey that was sent to all 145 therapists associated with Usona Institute’s Phase II clinical trial of psilocybin for major depressive disorder.”

They said that 32 of those individuals participated in the survey, representing a 22% response rate. 

In their conclusion, the authors said that “study was limited by a low response rate and a lack of diversity among participants,” as “the majority of psychedelic therapists identified as white, female, and having doctoral degrees.” 

The authors also noted that six individuals “did not fully complete the survey and were removed from all analyses,” and that “all six of these participants stopped the survey when prompted to answer questions regarding their personal substance use.”

“Future research is needed to address these limitations as well as to identify whether personal experience with psychedelics contributes to therapists’ competency or introduces bias to the field,” they wrote. 

“One interpretation of the low response rate is that only a small proportion of the practitioners working as psychedelic facilitators felt comfortable answering questions—anonymously and confidentially—about their personal experiences with psychedelic substances, but other explanations such as the lack of compensation for participating in the study may also be relevant,” the authors added.

Still, the findings are significant, particularly as psychedelic therapy continues to become more prevalent. 

“This sample of psychedelic therapists had considerable experience using classic psychedelic drugs and related hallucinogens themselves, with 28 of 32 (88%) endorsing use of a classic psychedelic and all but 1 participant trying at least one hallucinogen-related substance. This figure differs from the general population lifetime rate of psychedelic use, which tends to be around 10–15%; although several recent studies have indicated that usage seems to be increasing. Only one of four individuals without previous classic psychedelic experience had previous psychedelic training, making these individuals unique and relatively psychedelic-naive candidates to provide the treatment. Given their paucity of experience in the field, these individuals may represent interesting case studies in understanding the role of experiential learning with psychedelics,” the authors wrote.

They continued: “In terms of intentions, personal development and spiritual growth were the most common reasons reported for substance use, particularly with the classic psychedelics. However, most participants also reported intentions related to having fun and curiosity … Although the role of intentions has often been noted as being critical to the acute experience and subsequent outcomes among psychedelic users … there has been limited research prospectively testing the relationship between intentions and drug effects. Nonetheless, our results add to a growing body of literature suggesting a distinct set of intentions among psychedelic users.”

The post Study: Personal Psychedelic Use Common Among Therapists appeared first on High Times.

Utah Lawmaker Files Bill To Explore Therapeutic Use of Psychedelics

January 21, 2022 Published by

A Utah lawmaker has introduced a bill to explore the potential of psychedelic drugs to treat serious mental health conditions including depression, anxiety and PTSD. The legislation, House Bill 167, was introduced on Tuesday by Utah state Representative Brady Brammer, who noted that the measure “doesn’t legalize anything.”

“It asks our Huntsman Mental Health Institute and other experts in the field to review the science that’s out there, the research that’s out there, and make any recommendations that they have if they feel psychedelics can be safely administered through a prescription basis and under what circumstances,” Brammer said in a television news interview.

If passed, HB 167 would direct the state’s Health and Human Services Department to create a Mental Illness Psychotherapy Drug Task Force. The group would “study and make recommendations on drugs that may assist in treating mental illness,” according to the text of the legislation. The legislation specifies the makeup of the task force, which would include mental health professionals, researchers and patients.

Although the bill does not specifically mention psychedelics or any particular drug, the task force would be authorized to “provide evidence-based recommendations on any psychotherapy drug that the task force determines may enhance psychotherapy when treating a mental illness.” The legislation would empower the task force to study the research into psychedelic drugs, which has shown the potential to treat serious mental health conditions.

“We need effective tools to treat mental illness,” Brammer said in a statement to local media. “If psychedelics can be helpful and safely administered, we need them in our toolbox.”

Cannabis Activists Support Utah Psychedelics Bill

Brammer’s bill is supported by groups that campaigned for Proposition 2, the 2018 ballot initiative that legalized medical marijuana in Utah. Kylee Shumway, the medical director for the Utah Patients Coalition, said that psychedelics may be able to help residents of the state who are struggling with mental illness.

“We have higher rates of depression and anxiety than a lot of other states and even for people that are looking for help, there’s not enough psychiatrists; there’s not enough mental health professionals to help them,” said Shumway. “And a lot of the medications aren’t working.”

Research into psychedelics including psilocybin, MDMA and ketamine has shown that the drugs have potential therapeutic benefits, particularly for serious mental health conditions such as depression, addiction and anxiety. Research published in the journal JAMA Psychiatry in 2020 found that psilocybin-assisted psychotherapy was an effective and quick-acting treatment for a group of 24 participants with major depressive disorder. A separate study published in 2016 determined that psilocybin treatment produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer.

“It’s very promising,” Shumway exclaimed. “There are some huge studies that have just been finished recently on psilocybin that put it head to head against SSRIs which are antidepressants and psilocybin performed better across the board.”

“Utah has some of the finest researchers in the areas of psychiatry and neurosciences at Huntsman Mental Health Institute,” said Brammer. “This bill seeks to leverage that expertise, along with other experts grappling with mental illness, to review the research results, and if appropriate, make recommendations on how to safely administer these therapeutics under the care of qualified physicians.”

Steve Urquhart, a former Republican Utah state senator, also supports Brammer’s bill to explore the therapeutic potential of psychedelic drugs.

“Psychedelics changed my life,” he told local media. “It changed the way I see myself, the way I regard myself, and that allows me to see others and love others a lot more.”

Urquhart is the founder of The Divine Assembly, a Utah church that promotes religious and responsible use of psilocybin. 

“I’ve always been a bit of an activist at heart, and I decided I wanted to form a church where people can have these freedoms to worship with psychedelics,” Urquhart said. “I tell people, don’t get too lost on psychedelics; The Divine Assembly is about connection, and psychedelics can help with that.”

Urquhart believes that state lawmakers are likely to appreciate the cautious approach HB 167 takes to explore the benefits of psychedelics and may eventually support the legislation.

“Remember, this is Utah. Of course, we’re likely to take a slower approach to something like this,” he noted. “But on things like this, when the process runs, when it works, Utah can kind of come up with some magic. I’m optimistic about this.”

Brammer introduced HB 167 in the Utah House of Representatives on January 18. The bill has been referred to the House Rules Committee for consideration.

The post Utah Lawmaker Files Bill To Explore Therapeutic Use of Psychedelics appeared first on High Times.