Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder

NCT ID: NCT05562973

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2025-12-31

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce post-traumatic stress disorder (PTSD) severity in a sample of individuals with PTSD.

Detailed Description

The proposed Phase I study aims to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce PTSD severity in a sample of individuals with PTSD. A sample of up to 30 individuals with PTSD will be recruited. All participants will receive the intervention, which will consist of three psilocybin sessions with an interval of approximately 2 weeks between each session. A 3+3 Phase I trial design will be used to evaluate a range of possible dose sequences with doses ranging from 15 mg up to 45 mg. Safety, tolerability, and efficacy endpoints will be evaluated 2 weeks following each psilocybin session and at 1-month, 3-month, and 6-month follow-ups.

Conditions

Post-Traumatic Stress Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Sequence 1 (15, 20, 25)

Psilocybin dose sequence

Session 1: 15 mg Session 2: 20 mg Session 3: 25 mg

Group Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

Participants will receive three psilocybin sessions, at least two weeks apart.

Dose Sequence 2 (20, 25, 30)

Psilocybin dose sequence

Session 1: 20 mg Session 2: 25 mg Session 3: 30 mg

Group Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

Participants will receive three psilocybin sessions, at least two weeks apart.

Dose Sequence 3 (25, 30, 35)

Psilocybin dose sequence

Session 1: 25 mg Session 2: 30 mg Session 3: 35 mg

Group Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

Participants will receive three psilocybin sessions, at least two weeks apart.

Dose Sequence 4 (30, 35, 40)

Psilocybin dose sequence

Session 1: 30 mg Session 2: 35 mg Session 3: 40 mg

Group Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

Participants will receive three psilocybin sessions, at least two weeks apart.

Dose Sequence 5 (35, 40, 45)

Psilocybin dose sequence

Session 1: 35 mg Session 2: 40 mg Session 3: 45 mg

Group Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

Participants will receive three psilocybin sessions, at least two weeks apart.

Interventions

Psilocybin

Participants will receive three psilocybin sessions, at least two weeks apart.

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• Have given written informed consent
• Read, write, and speak English
• At Screening, meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a symptom duration of 6 months or longer according to the Clinician-Administered PTSD Scale for DSM-5
• Able to complete the study measures
• Previously sought treatment for PTSD (e.g., prolonged exposure therapy, cognitive processing therapy, sertraline, paroxetine)
• Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests (Complete Blood Count, Comprehensive Metabolic Panel, urine beta-human chorionic gonadotropin, urine toxicology screen).

• Current physical dependence (as evidenced by self-reported withdrawal symptoms) on a drug other than caffeine or nicotine
• Seizure disorder
• Receiving current treatment for PTSD
• Cardiovascular conditions: angina, a clinically significant ECG abnormality (e.g. atrial fibrillation or corrected QT interval >450msec), transient ischemic attack (TIA) in the last 6 months, stroke, or uncontrolled hypertension with resting blood pressure systolic >150 or diastolic >95.
• Recent (<1year) intracranial or subarachnoid hemorrhage, ischemic stroke, TIA
• Pulmonary disease: chronic obstructive pulmonary disease, active asthma (inhaler use in last 6 months)
• Diabetes mellitus treated with insulin or oral hypoglycemic agents
• Current suicidal ideation or suicidality
• Current engagement in evidence-based PTSD therapy/treatment (prior to psilocybin session)
• Women: Pregnancy (pregnancy tests will be conducted for women during screen and prior to experimental sessions).
• Current or past history of meeting DSM-5 criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I Disorder.
• Currently taking efavirenz or serotonin-acting dietary supplements (e.g., 5-hydroxy- tryptophan, St. John's wort).
• Currently taking antidepressants of any drug class, antipsychotics, or monoamine oxidase inhibitors.
• Recent (within past 12 months) or extensive history of hallucinogen use (>20 lifetime uses).
• Moderate or severe DSM-5 Substance Use Disorder in the past five years (excluding tobacco and caffeine)
• Family (i.e., 1st degree relative) history of Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I Disorder.
• For the final (5th) dose sequence (35, 40, and 45 mg) participants that weigh less than 50 kg

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew W Johnson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

References

Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513.

Reference Type: BACKGROUND

PMID: 27909165 (View on PubMed)

Other Identifiers

IRB00288303

Identifier Type: -

Identifier Source: org_study_id