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

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will serve as a pilot randomized controlled trial to assess the feasibility of Psilocybin-Assisted Psychotherapy (PAP) in Treating Irritable Bowel Syndrome (IBS). Patients with severe IBS will undergo 3 pre-psychotherapy sessions with two licensed and trained psychedelic therapists, then will be randomized to undergo a guided psychotherapy session with single 25 mg oral "high" dose of psilocybin or a single 100 mg dose of niacin (active placebo) and attend 4 post-therapy integration sessions.

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 psilocybin generally safe for use in humans?

Psilocybin has been studied in healthy adults and for various psychiatric conditions, showing that it is generally safe when used in a controlled, supervised setting. Most side effects are mild and temporary, though some people may experience anxiety or panic at higher doses. Serious side effects are rare, but further research is needed to fully understand its safety profile. ^{1 2 3 4 5}

How does the drug psilocybin differ from other treatments for irritable bowel syndrome?

Psilocybin is unique because it is a psychedelic drug that, when used in therapy, can produce rapid and lasting psychological effects with just one or two doses, unlike traditional treatments for irritable bowel syndrome that often require ongoing medication. It works by influencing psychological experiences and has shown promise in treating mood and anxiety disorders, which may indirectly benefit IBS patients by addressing stress-related symptoms. ^{6 7 8 9 10}

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 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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Acute, subacute and long-term subjective effects of psilocybin in healthy humans: a pooled analysis of experimental studies. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Psilocybin-Assisted Therapy: A Review of a Novel Treatment for Psychiatric Disorders. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Psilocybin history, action and reaction: A narrative clinical review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Potential Therapeutic Effects of Psilocybin: A Systematic Review. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The development of psilocybin therapy for treatment-resistant depression: an update. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

[Psilocybin-Assisted Treatment of Depression, Anxiety and Substance use Disorders: Neurobiological Basis and Clinical Application]. [2023]