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Psychedelic
Psilocybin + Psychotherapy for Demoralization (PATH Trial)
Phase 2
Waitlist Available
Led By Yvan Beaussant, MD
Research Sponsored by Yvan Beaussant
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Psilocybin is very likely to have no genotoxic effects. One study that directly focused on the mutagenic potential of psilocybin did not found this type of toxicity. However, due to the lack of clinical and non-clinical studies on the effects of psilocybin on the developing human fetus, women and men of child-bearing potential and who are sexually active must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence) throughout their participation in the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of psilocybin administration
Palliative Performance Scale (PPS) ≥ 50 % (see Appendix A)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
PATH Trial Summary
This trial is testing whether or not psilocybin can help people who are demoralized and receiving hospice care.
Who is the study for?
This trial is for adults over 21 in hospice care with any terminal illness, experiencing moderate-to-severe demoralization. They must have a caregiver present after taking the study drug and not drive for 24 hours post-administration. Participants need to use contraception if of childbearing potential. Exclusions include those with certain psychiatric conditions or family history, significant suicide risk, allergies to similar drugs, or on medications that could interact poorly.Check my eligibility
What is being tested?
The study tests psilocybin-assisted psychotherapy's effectiveness in reducing feelings of hopelessness among terminally ill patients receiving hospice care. Psilocybin is administered under controlled conditions alongside sessions of psychotherapy to evaluate its impact on demoralization.See study design
What are the potential side effects?
While specific side effects are not listed here, psilocybin can potentially cause changes in sensory perception and mood, confusion, headache, nausea, psychological distress or exacerbation of pre-existing mental health issues during the period it affects the brain.
PATH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use birth control during and 4 months after the study.
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I am mostly independent but may need some help with daily activities.
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I am 21 years old or older.
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I do not have any terminal illness.
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I am 21 years old or older.
PATH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average time delay from screening to enrollment
Duration of assessment visits
Mean number of sessions completed by enrolled participants
+4 moreSecondary outcome measures
Change in Caregiver- CarGOQoL Score
Change in Challenging Experience Questionnaire (CEQ) Score
Change in Global Quality Life Score as assessed by Functional Assessment of Chronic Illness Therapy - Palliative Care 14 (FACIT-Pal 14)
+11 morePATH Trial Design
1Treatment groups
Experimental Treatment
Group I: PATHExperimental Treatment2 Interventions
The research study procedures include screening for eligibility, and study intervention including preparation, evaluations, one psilocybin session and follow up visits.
-The treatment regimen consists of a single administration of psilocybin 25 mg orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730
Psychotherapy
2020
Completed Phase 3
~3120
Find a Location
Who is running the clinical trial?
Council on Spiritual Practices Fund at the San Francisco FoundationUNKNOWN
Jack SmithUNKNOWN
Yvan BeaussantLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a very serious illness that cannot be cured.You have a history of mental health conditions like schizophrenia, bipolar disorder, or personality disorders.I have trouble eating or absorbing food.I agree to use birth control during and 4 months after the study.I am mostly independent but may need some help with daily activities.My primary reason for hospice care is end-stage liver disease or cirrhosis.I do not have any severe health conditions that could affect my participation in the study.You have had thoughts of hurting yourself or have made plans to hurt yourself in the past month.My liver tests are very high, or I have signs of liver failure like confusion or yellowing skin.You have had allergic reactions to substances that are similar to psilocybin in their chemical or biological makeup.I am not taking medications that could badly interact with the study drugs.I am 21 years old or older.I do not have any terminal illness.I have a parent, sibling, or child with schizophrenia or bipolar disorder.I am currently undergoing chemotherapy.I am not pregnant, nursing, or planning to become pregnant.I won't drive for 24 hours after getting the study drug.I am 21 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: PATH
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current participant count in this research project?
"Affirmative, the facts listed on clinicaltrials.gov demonstrate that this experiment is recruiting volunteers at present. The trial was initially posted to the website on March 9th 2022 and saw its last update on May 23rd 2022. As of now, 15 patients are being accepted from a single site."
Answered by AI
What are the fundamental aims of this experiment?
"The stated purpose of this clinical trial, which is expected to take an average of 1 year to complete, is to recruit a specific number of participants per month. The primary outcomes being measured include change in physical domain score as assessed by the PROMIS Pain Interference Scale (PIS), Edmonton Symptom Assessment System (ESAS) and Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 (FACIT-sp-12). Secondary objectives focus on determining the participant's spiritual wellbeing through faith, meaning, peace and other self reported factors."
Answered by AI
What other empirical investigations have been conducted with regards to psychotherapeutic interventions?
"As of recently, 33 medical trials for psychotherapy therapies are in progress. Of these studies, none have reached phase 3 yet. These trials span 36 different locations with the most being located in Vancouver, Washington."
Answered by AI
To what extent is psychological counseling a safe and trustworthy form of treatment?
"Data on psychotherapy's safety exists, so it has been given a score of 2. Nevertheless, there is no extant research that confirms its efficacy."
Answered by AI
Are any opportunities available for individuals who are looking to partake in this research?
"Affirmative, clinicaltrials.gov lists this medical study as recruiting subjects at present. This research was first posted on the 9th of March 2022 and most recently adjusted on the 23rd of May 2022; 15 participants will be accepted from one location for participation."
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
California
Other
Massachusetts
How old are they?
65+
18 - 65
What site did they apply to?
Care Dimensions
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have a progressive disease that has impacted my ability to stand and walk.
PatientReceived 2+ prior treatments
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