RECRUITING

Open-Label Psilocybin Study in Transdiagnostic Population

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Conditions

TransdiagnosticDepression - Major Depressive DisorderAnxietyPTSD SymptomsPTSDSubstance UseSubstance Use Disorder (SUD)OCDdepressionaddictionpsilocybinpsychedelic

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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 primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms. The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing. The investigators will recruit individuals with mood, anxiety, trauma, addictive, or related symptomatology, and who have functional impairment associated with these symptoms. A DSM-5 diagnosis is not required (nor is it an exclusion). The investigators will allow for comorbidity and only exclude based on psychological and physiological safety considerations. Critically, this approach will allow us to assess the tolerability of our interventions in individuals who would typically be excluded from efficacy studies due to various comorbid DSM-5 conditions. The investigators will employ an open-label study where participants will be given one dose of oral psilocybin 25mg. The investigators will also have follow-up visits at 1, 4, and 6 weeks and an optional long-term follow-up at 3, 6, and 12 months.

Official Title

Safety, Feasibility, and Tolerability of Psilocybin Treatment for Individuals With Functional Impairment Related to Mood, Anxiety, Trauma and/or Addiction Symptoms: An Open-label Proof-of-concept Study

Quick Facts

Study Start:2024-10-17
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06442423

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. At least one psychiatric symptom causing functional impairment over the past 30 days as established by a trained rater on the DIAMOND (at least "mild" impairment) and/or the WHODAS-2.0 12-item (a raw score of \>16) - assessment instruments indexing health and disability.
  2. 2. English fluency - able to understand the process of consent and the risk and benefits associated with the study, and able to provide written (signed and dated) informed consent form.
  3. 3. Agree to set up safe transportation after leaving the site following the dosing session. Acceptable arrangements include: arranging for a friend/family member to drive them home, pick them up and escort them home; if the participant is unable to arrange for a friend/family member to escort them home, the study staff will arrange private transportation and follow up with the participant to ensure that they arrived at their destination.
  4. 4. Must be able to identify a physician/treater that can be contacted to further assure that it is safe for the subject to participate and agree to sign a medical release for the investigators to communicate directly with this outside provider to confirm treatment and medical history via phone and/or email.
  5. 5. Ability to orally ingest pills for psilocybin dosing visit.
  6. 6. Must provide an adult contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the PI and/or study personnel in the event of an emergency, and who can provide transportation for study visits if necessary and independently comment on any changes in the participant's mood or behavior after the administration of psilocybin. Be medically stable (no medical issues based on physical exam, labs and medical evaluation) as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an ECG, and routine blood and urinalysis laboratory tests (see section 6.3.4 for labs). Must also demonstrate decisional capacity based on clinical assessment ensuring the participant can understand, appreciate, and reason through the study's purpose, procedures, and associated risks, as well as tolerate the potential effects of the study medication.
  7. 7. Be psychologically stable: Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least one month prior to screening and is expected to remain stable during participation in the study (up to 4-weeks post-dosing).
  8. 8. If participant is of childbearing potential, must agree to use adequate birth control and not attempt to become pregnant during study up to 4 weeks post dosing session (see Section 6.3.3).
  9. * Premenarchal.
  10. * Premenopausal with 1 of the following:
  11. 1. Documented hysterectomy or bilateral salpingectomy/tubal occlusion/oophorectomy.
  12. 2. Postmenopausal.
  13. * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
  14. * Females receiving hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use 1 of the nonhormonal, highly effective contraception methods if they wish to continue their HRT during the trial.
  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

Study Contact

Geena Fram
CONTACT
(203) 444-1795
enact@yale.edu

Principal Investigator

Benjamin Kelmendi, MD
PRINCIPAL_INVESTIGATOR
Yale University
Gabrielle Agin-Liebes, PhD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Connecticut Mental Health Center - Yale School of Medicine
New Haven, Connecticut, 06519
United States

Collaborators and Investigators

Sponsor: Yale University

  • Benjamin Kelmendi, MD, PRINCIPAL_INVESTIGATOR, Yale University
  • Gabrielle Agin-Liebes, PhD, PRINCIPAL_INVESTIGATOR, Yale 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 Date2024-10-17
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-10-17
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • depression
  • anxiety
  • substance use
  • addiction
  • PTSD
  • OCD
  • psilocybin
  • psychedelic

Additional Relevant MeSH Terms

  • Transdiagnostic
  • Depression - Major Depressive Disorder
  • Anxiety
  • PTSD Symptoms
  • PTSD
  • Substance Use
  • Substance Use Disorder (SUD)
  • OCD