Psilocybin-Assisted Psychotherapy for Irritable Bowel Syndrome

Overseen By Maysaa El Zoghbi

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: NYU Langone Health

Must not be taking: Antidepressants, Antipsychotics, Mood stabilizers, others

Disqualifiers: Heart disease, CNS pathology, Psychotic disorders, others

Compensation: Varies

Number of Visits: 8

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of psilocybin, a compound found in certain mushrooms, to help individuals with severe irritable bowel syndrome (IBS) who haven't found relief with other treatments. Participants will undergo therapy sessions before and after a guided session with either a high dose of psilocybin or a placebo (niacin). The goal is to determine if psilocybin-assisted therapy can effectively manage IBS symptoms. This trial suits those who experience frequent and severe IBS episodes despite medication and have visited the emergency room for abdominal pain in the past year. As an Early Phase 1 trial, this research focuses on understanding how psilocybin works in people, offering participants a chance to be among the first to receive this innovative treatment.

Do I need to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications, including antidepressants, centrally-acting serotonergic agents, antipsychotics, mood stabilizers, and some dietary supplements like St. John's wort. The trial does not specify a washout period, but these medications must not be taken during the study.

Is there any evidence suggesting that psilocybin is likely to be safe for humans?

Research has shown that psilocybin is generally well-tolerated in past studies. Some studies have examined its use for mental health, finding that most participants experienced only mild and short-lived side effects. Common side effects included headaches, nausea, and changes in mood or perception.

Specific safety information for using psilocybin to treat irritable bowel syndrome (IBS) is not yet available. However, the FDA has approved psilocybin for other research purposes, suggesting it is considered safe enough to study. This trial is in the early stages and aims to assess how well participants tolerate the treatment. While specific safety data for IBS is lacking, past research in other areas supports further study of psilocybin. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for IBS?

Researchers are excited about using psilocybin for irritable bowel syndrome (IBS) because it offers a fresh approach compared to traditional treatments like dietary changes, fiber supplements, and antispasmodic medications. Unlike these standard options, psilocybin works by affecting serotonin receptors in the brain, which might help regulate gut function and reduce IBS symptoms. Additionally, psilocybin has the potential to provide long-lasting benefits after just a few sessions, unlike daily medications that need continuous use. This novel mechanism and the promise of lasting relief make psilocybin a promising candidate for those struggling with IBS.

What evidence suggests that Psilocybin-Assisted Psychotherapy could be an effective treatment for IBS?

Research shows that psilocybin, the main ingredient in magic mushrooms, might help treat irritable bowel syndrome (IBS) by influencing the gut-brain connection. Early results suggest that psilocybin therapy could ease IBS symptoms by reducing stress and anxiety, which are known to worsen IBS. Although direct evidence on psilocybin for IBS remains limited, studies on similar conditions have shown promising results for improving mental health and overall well-being. This potential improvement could make life easier for people with IBS. Participants in this trial will receive either psilocybin or a placebo (niacin) to further investigate these early findings. ^{1 2 3 5 6}

Who Is on the Research Team?

Maysaa El Zoghbi

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals with severe Irritable Bowel Syndrome (IBS). Participants must be willing to undergo psychotherapy sessions and take a single dose of either psilocybin or niacin. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Have an identified support person

I agree to have someone take me home after treatment.

Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study

Exclusion Criteria

Unstable medical conditions or serious abnormalities on complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial

Cognitive impairment as defined by Montreal Cognitive Assessment Test (MoCA) < 23

Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Methamphetamine, 3,4-methylenedioxymethamphetamine (MDMA), Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-psychotherapy Sessions

Participants undergo 3 pre-psychotherapy sessions with licensed and trained psychedelic therapists

3 weeks

3 visits (in-person)

Treatment

Participants are randomized to receive a guided psychotherapy session with either a single 25 mg oral dose of psilocybin or a 100 mg dose of niacin (active placebo)

1 day

1 visit (in-person)

Post-therapy Integration Sessions

Participants attend 4 post-therapy integration sessions

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The study tests Psilocybin-Assisted Psychotherapy (PAP) against an active placebo, niacin, in treating IBS. It includes pre-psychotherapy sessions, one session with a high dose of psilocybin or niacin, followed by post-therapy integration meetings.

How Is the Trial Designed?

Group I: Intervention: Psilocybin Experimental Treatment 2 Interventions

Participants assigned to the intervention arm will receive psilocybin.

Group II: Control: Niacin (Placebo) Placebo Group 2 Interventions

Participants assigned to the control arm will receive a placebo (niacin).

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

A systematic review of 16 studies found that psilocybin is generally well-tolerated, with the most common side effects being transient nausea and headache, and no reports of severe long-term issues like psychosis.

Psilocybin shows promise as a safe treatment option for psychiatric and substance-dependence conditions, particularly for patients who do not respond to standard therapies, as it has demonstrated both acute and long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Tolerability and Safety of Psilocybin in Psychiatric and Substance-Dependence Conditions: A Systematic Review. Kaminski, D., Reinert, JP.[2023]

In a study of 27 patients with moderate to severe major depressive disorder, psilocybin-assisted treatment showed significant and lasting antidepressant effects, with 75% of participants experiencing a treatment response and 58% achieving remission after 12 months.

There were no serious adverse events related to psilocybin, indicating a favorable safety profile, and participants reported meaningful personal and spiritual experiences that correlated with increased well-being, although these did not directly predict improvements in depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. Gukasyan, N., Davis, AK., Barrett, FS., et al.[2022]

Psilocybin has shown promise in reducing symptoms of depression and anxiety, particularly in cancer patients, with effects lasting for at least six months after a single treatment, based on three controlled studies.

In small pilot studies, psilocybin has also demonstrated potential effectiveness in treating addiction to alcohol and cigarettes, suggesting its versatility as a therapeutic agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Therapeutic Effects of Psilocybin: A Systematic Review. Goel, DB., Zilate, S.[2022]

Psilocybin, a psychedelic drug, shows promising safety and efficacy in treating major depression and treatment-resistant depression (TRD), with initial phase 2 trials indicating positive outcomes when combined with psychological support.

The first international randomized controlled trial in 2022 found that a 25 mg dose of psilocybin was effective compared to an active placebo, and phase 3 trials are set to begin in 2023, suggesting a growing interest in psilocybin as a viable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of psilocybin therapy for treatment-resistant depression: an update. Borissova, A., Rucker, JJ.[2023]

In a placebo-controlled study involving individuals with moderate to severe major depressive disorder, psilocybin (0.3 mg/kg) showed larger antidepressant effect sizes compared to placebo, with 66.7% of participants responding and 46.7% achieving remission after treatment.

The antidepressant effects of psilocybin persisted for an average of 2 months, indicating its potential as a long-lasting treatment option for depression, although the strength of the mystical experience during dosing did not correlate with these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial. Sloshower, J., Skosnik, PD., Safi-Aghdam, H., et al.[2023]

In a study involving 12 healthy adults, escalating doses of psilocybin (0.3, 0.45, and 0.6 mg/kg) were administered safely, with no serious adverse events reported, indicating a favorable safety profile for this psychedelic compound.

The pharmacokinetics of psilocin, the active metabolite of psilocybin, were linear across the tested doses, with an elimination half-life of about 3 hours, suggesting that no dose adjustments are necessary for individuals with mild to moderate renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Brown, RT., Nicholas, CR., Cozzi, NV., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06206265

NCT06206265 | Assessment of Psilocybin (TRP-8802) in ... This study will involve a randomized waitlist control design to investigate the rapid and sustained effects of TRP-8802 following two experimental sessions.

2. medicalnewstoday.com medicalnewstoday.com/articles/could-psilocybin-help-treat-ibs-new-study-investigates

Could psilocybin help treat IBS? A new study investigates researcher Erin Mauney believes psilocybin — the active compound in magic mushrooms — might help treat irritable bowel syndrome (IBS) ...

3. psychiatrictimes.com psychiatrictimes.com/view/the-gut-brain-connection-an-upcoming-study-on-psilocybin-assisted-psychotherapy-and-irritable-bowel-syndrome

An Upcoming Study on Psilocybin-Assisted Psychotherapy ... A phase 2A trial recently received confirmation to proceed in investigating psilocybin-assisted psychotherapy in the treatment of adult patients with IBS.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39998940

Psychedelic-assisted Therapy as a Promising Treatment for ... We argue that this evidence suggests PAT is worthy of study as a new therapy for IBS, and potentially for other disorders of gut-brain interaction (DGBI).

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165614723002766

Do the therapeutic effects of psilocybin involve actions in ... No studies have investigated the possibility that peripheral actions of psilocybin may contribute to improvements in mental health outcomes.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06760533

Psilocybin-Assisted Psychotherapy in Treating Irritable ... This study will serve as a pilot randomized controlled trial to assess the feasibility of Psilocybin-Assisted Psychotherapy (PAP) in Treating Irritable ...