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Psychedelic Therapy

Psilocybin Assisted Psychotherapy for Cancer Recurrence

Phase 1
Recruiting
Led By Stacy Fischer, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged ≥ 21
Functional Status defined as Eastern Cooperative Oncology Group (ECOG) ≤1, Palliative Performance Scale (PPS) ≥60%, Ability to tolerate PO medication administration
Must not have
Risk for hypertensive crisis
Significant central nervous system (CNS) pathology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for the duration of study participation -6 months
Awards & highlights

Summary

This trial aims to see if using psilocybin, along with therapy, can help women with early breast cancer and ovarian cancer in remission to reduce their fear of cancer recurrence. Participants will undergo

Who is the study for?
This trial is for women who have had early breast or ovarian cancer and are now in remission but are struggling with the fear that their cancer will come back. They should be open to therapy sessions and taking psilocybin under supervision.
What is being tested?
The study is testing if therapy combined with a moderate dose of psilocybin can reduce the fear of cancer coming back, as well as improve anxiety, depression, and overall quality of life in these women.
What are the potential side effects?
Psilocybin may cause temporary changes in perception, mood swings, dizziness, lack of coordination, or headaches. These effects are generally short-lived and monitored by professionals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or older.
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I can care for myself and perform light activities, and I can take pills by mouth.
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I have late-stage ovarian cancer with a high risk of coming back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am at risk for a severe increase in blood pressure.
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I have a serious brain or spinal cord condition.
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My family has a history of serious mental health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for the duration of study participation -6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and for the duration of study participation -6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Fear of Cancer Recurrence Inventory
Secondary study objectives
Safety as measured by adverse events
Other study objectives
Anxiety
Cancer-related Existential Distress
Depression
+2 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Psilocybin Assisted PsychotherapyExperimental Treatment1 Intervention
25mg cGMP Psilocybin in combination with manualized therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~750

Find a Location

Who is running the clinical trial?

Usona InstituteOTHER
15 Previous Clinical Trials
957 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,786 Previous Clinical Trials
2,787,588 Total Patients Enrolled
29 Trials studying Breast Cancer
6,869 Patients Enrolled for Breast Cancer
Stacy Fischer, MDPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
14 Total Patients Enrolled
~13 spots leftby Dec 2026
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