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Psychedelic

Psilocybin Therapy for Cancer-related Chronic Pain

Phase 1
Waitlist Available
Led By Ali J. Zarrabi, MD
Research Sponsored by Emory University
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 at 98 days
Awards & highlights

Study Summary

This trial is testing if psilocybin, a compound in psychedelic mushrooms, can help cancer patients with anxiety, depression, and chronic pain.

Who is the study for?
This trial is for cancer survivors aged 26-85 with a life expectancy over six months, experiencing chronic pain and demoralization. They must have been diagnosed at least a year ago and have someone to care for them post-treatment. Exclusions include non-English speakers, substance abuse, certain medical conditions like seizures or severe heart disease, BMI <=18, renal insufficiency, use of specific drugs including SSRIs/SNRIs/MAOIs or efavirenz.Check my eligibility
What is being tested?
The trial tests the effects of psilocybin in combination with palliative psychotherapy on demoralized cancer survivors with chronic pain. It aims to see if this treatment can alleviate anxiety, depression and improve quality of life.See study design
What are the potential side effects?
Possible side effects may include temporary changes in perception and mood swings during psilocybin administration. Long-term side effects are being studied but could involve similar psychological reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 98 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 98 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of Feasibility Outcome To Assess Patient Retention in The Study
Incidence Of Treatment-Related Medical Grade 3 Or Higher Or Psychiatric Grade 4 Or Higher
Other outcome measures
Anxiety and Depression at Forty-Two Days
Anxiety
Caregiver strain at Forty-Two Days
+21 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive care (psilocybin, observation)Experimental Treatment4 Interventions
Patients receive psilocybin PO and undergo observation for up to 24 hours on day 14.
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?

Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,562 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,656 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Ali J. Zarrabi, MDPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What possible risks come with pursuing psychotherapy?

"As this is an early stage trial, with limited data regarding safety and efficacy, psychotherapy received a score of 1."

Answered by AI

How many participants are undergoing research for this experiment?

"Confirmatively, the data available on clinicaltrials.gov shows that this medical experiment is presently recruiting individuals to take part in it. It was initially advertised on October 31st 2022 and last modified on September 12th 2022; 10 participants are needed at 2 separate healthcare facilities."

Answered by AI

Are there any open enrolment spots available in this trial?

"According to clinicaltrials.gov, the research study is presently looking for participants and was posted on October 31st 2022 with updates applied September 12th of that year."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Other
Illinois
Florida
How old are they?
65+
18 - 65
What site did they apply to?
Brain Health Center at Executive Park
Emory University/Winship Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

Rev Trisha Senterfitt recommended this trial to me-or one foe cancer long haulers.
PatientReceived 2+ prior treatments
I am interested in psilocybin research. I am 4 years into a diagnosis and treatment for Stage 4 prostate cancer. I have completed treatments including surgery, radiation and 3 years of ADT. I am now basically undergoing cancer marker testing at 3 month intervals, and I'm in a wait and see holding pattern. I feel good, but I'm unsure how I am going to react if/when I test positive again for cancer.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long does the trial last? I will be traveling a fair distance. How many visits to Atlanta will be necessary and how long with each visit last?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain
Ali Zarrabi 2022. "Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05506982.
~2 spots leftby Aug 2024
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