ACTIVE_NOT_RECRUITING

A Study of Psilocybin for PTSD

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Conditions

Post Traumatic Stress Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The proposed open-label, controlled study at the Johns Hopkins Center for Psychedelic and Consciousness Research (CPCR) will test the following primary hypotheses in adult patients with chronic PTSD who are currently taking a serotonin reuptake inhibitor: psilocybin therapy will be feasible and safe for participants, significantly remediate PTSD symptoms, and enhance wellbeing and quality of life. In addition, the study will examine whether elements of evidence-based trauma-focused psychotherapy enhance treatment response when paired with psilocybin.

Official Title

Psilocybin for PTSD With or Without Psychotherapy: A Pilot Study of Safety and Efficacy

Quick Facts

Study Start:2024-06-07
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06407635

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be at least 21 years old
  2. * Have given written informed consent
  3. * Have a confirmed DSM-5 diagnosis of Post-Traumatic Stress Disorder with symptom duration \>= 6 months
  4. * Have a baseline CAPS-5 score of \>=35
  5. * Currently taking a serotonin reuptake inhibitor (SSRI or SNRI) at a stable dose for at least 3 months.
  6. * Be judged by study team clinicians to be at low acute risk for suicidality
  7. * Be 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
  8. * Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.
  9. * Agree to refrain from using alcohol, anxiolytics, stimulants, sedatives or hypnotics, opioids, dissociatives, cannabinoids, or other unapproved substances within 24 hours of psilocybin administration. Caffeine and nicotine are exceptions.
  10. * Agree not to take any as needed (PRN) medications on the mornings of drug sessions
  11. * Agree to stop taking 5HT2A antagonist medications at least 5 half-lives before psilocybin dosing.
  12. * Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.
  13. * Have no classic psychedelic use in the past five years.
  14. * Have at least a high school level of education or equivalent (e.g. GED).
  15. * Weigh at least 40kg.
  16. * (for female participants) Agree to use highly effective birth control measure within two weeks before and after dosing sessions.
  17. * (for male participants) Agree to use contraception and refrain from sperm donation two weeks before and after dosing sessions, as the reproductive safety for psilocybin is not yet established.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Sandeep Nayak, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Center for Psychedelic and Consciousness Research
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Sandeep Nayak, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-07
Study Completion Date2027-05

Study Record Updates

Study Start Date2024-06-07
Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

  • Post Traumatic Stress Disorder