What side effects are associated with this type of intervention?

Common treatments for PTSD include SSRIs (e.g., sertraline, paroxetine) and SNRIs (e.g., venlafaxine), which can cause side effects such as nausea, insomnia, sexual dysfunction, and increased anxiety. Psychedelic treatments like psilocybin and MDMA, currently under investigation, have shown potential but also carry risks. Psilocybin may cause transient anxiety, hallucinations, and emotional distress, while MDMA can lead to increased heart rate, blood pressure, and potential neurotoxicity. Both require careful administration and psychological support to mitigate adverse effects.

What prior FDA approvals exist?

Currently, the FDA has approved two medications for the treatment of Post-Traumatic Stress Disorder (PTSD): paroxetine and sertraline, both of which are selective serotonin reuptake inhibitors (SSRIs). These medications do not have psychedelic properties similar to psilocybin. While psilocybin and other psychedelics have shown promise in early trials for various psychiatric conditions, including treatment-resistant depression and anxiety, they have not yet been approved by the FDA for PTSD. Research is ongoing to explore the potential of psilocybin and other psychedelics in treating PTSD and other mental health disorders.

What other types of research exist?

Promising novel alternatives to psilocybin for PTSD treatment include MDMA, which has shown significant reductions in traumatic stress, depression, and anxiety symptoms in diverse populations. Additionally, gabapentin has demonstrated efficacy in reducing cannabis use and withdrawal symptoms, which may be beneficial for PTSD patients with comorbid substance use disorders. Both substances have been well tolerated in clinical trials.

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Psychedelic Substance

Psilocybin for PTSD

Phase 2

Waitlist Available

Led By Gosia Phillips, MD

Research Sponsored by Halucenex Life Sciences Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 month follow up

Awards & highlights

Summary

This trial is testing psilocybin, a substance from 'magic mushrooms,' on people with PTSD who don't respond to current treatments. Psilocybin helps the brain grow and reduces fear response, which may improve mood and reduce anxiety. Psilocybin has shown promise in treating anxiety and depression in patients with life-threatening cancer, with significant and sustained symptom reduction.

Who is the study for?

This trial is for adults aged 18-70 with treatment-resistant PTSD, having moderate to severe symptoms despite at least 3 months of SSRI or SNRI treatment and 4 months of psychotherapy. Participants must understand English. Excluded are those with certain psychiatric disorders, uncontrolled medical conditions, recent substance abuse, high caffeine intake, or who are pregnant without using contraception.

What is being tested?

The study tests the effects of psilocybin on individuals with PTSD that hasn't improved after standard treatments. It aims to see if psilocybin can alleviate PTSD symptoms when traditional medications like paroxetine and sertraline have failed.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects from similar studies may include temporary anxiety or panic reactions during dosing sessions, changes in blood pressure and heart rate, nausea, headache and potential psychological distress.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PTSD symptom severity as measured by the Clinician-Administered PTSD Scale (CAPS-5)

PTSD symptom severity as measured by the Posttraumatic Checklist for the DSM-5 (PCL-5)

Primary efficacy of psilocybin using the 11-Dimension Altered States of Consciousness (11D-ASC) will assess

+3 more

Secondary study objectives

Anxiety as measured by the Beck Anxiety Inventory (BAI).

Anxiety as measured by the State Trait Anxiety Inventory - Trait Version (STAI-T).

Body Mass Index (BMI)

+4 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Diarrhea

Influenza

Headache

Sinus headache

Depressed mood

Depression

Insomnia

Suicidal Ideation

Lower resp. tract congestion

Oropharyngeal pain

Alcohol withdrawal syndrome

Migraine

Thrombocytosis

Constipation

Vomiting

Oedema

Peripheral swelling

Pyrexia

Dermatitis contact

Bronchitis bacterial

Eye infection

Fungal infection

Traumatic lung injury

Hyponatremia

Arthralgia

Musculoskeletal pain

Pain in extremity

Malignant melanoma

Dizziness

Hypoesthesia

Sedation

Anger

Anxiety

Restlessness

Cough

Rhinorrhea

Sinus congestion

Sexual abuse

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

Trial Design

1Treatment groups

Experimental Treatment

Group I: Psilocybin treatment for treatment-resistant PTSDExperimental Treatment1 Intervention

Experimental Treatment: Experimental: Psilocybin 10mg (low dose) on Day 7 25mg (high dose) on Day 14 10mg dose (optional top-up low dose) at Month 7 Treatment Description: Drug: Psilocybin drug product suspension Psilocybin is manufactured as a bulk API powder. The psilocybin drug product suspension is prepared by a compounding pharmacist at the clinic site. The psilocybin drug product suspension will be mixed in a glass with water to produce the psilocybin solution for oral consumption. Subjects will be instructed to orally consume the study medication in the glass in its entirety. Psilocybin will be administered in the following doses and at the following time points for this study: * 1 mL of 10mg/mL (low dose) on Day 7 (10 mg) * 2.5 mL of 10 mg/mL (high dose) on Day 14 (25 mg) * \[Optional dose\] 1 mL of 10mg/mL (low dose) on Month 7/Day 210 (10 mg)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

Not yet FDA approved

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for PTSD, such as SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors), work by increasing the levels of serotonin and norepinephrine in the brain, which helps to regulate mood and anxiety. Psilocybin, a psychedelic compound, is being studied for its potential to treat PTSD by affecting neurobiological pathways, including serotonin receptors, which may help in reducing symptoms like anxiety, depression, and re-experiencing traumatic events. These mechanisms are crucial for PTSD patients as they target the underlying neurobiological disruptions that contribute to the disorder, potentially offering faster and more effective symptom relief compared to traditional treatments.

PTSD: from neurobiology to pharmacological treatments.