Your session is about to expire
← Back to Search
Psychedelic Therapy
Psilocybin for Cancer Pain
Phase 2
Recruiting
Led By Yvan Beaussant, MD
Research Sponsored by Yvan Beaussant, MD, MSci
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 3 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at using psilocybin to reduce pain in people with advanced cancer that don't respond to traditional opioid treatments.
Who is the study for?
Adults with advanced cancer experiencing pain not relieved by opioids, on a high opioid dose, and seen by palliative care recently. They must be able to take pills, consent to the study, have certain organ functions within safe ranges, and commit to lifestyle changes for the trial. Pregnant women or those who can become pregnant without effective birth control are excluded.
What is being tested?
The trial is testing psilocybin-assisted therapy's safety and ability to reduce pain in patients with advanced cancer whose pain isn't managed by opioids. Participants will receive doses of psilocybin under controlled conditions.
What are the potential side effects?
Possible side effects include temporary changes in perception, mood swings, nausea, headaches, increased heart rate or blood pressure during treatment sessions. Long-term psychological effects are also possible but rare.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of Psilocybin-Assisted Therapy
Feasibility of Psilocybin-Assisted Therapy
Secondary study objectives
Change in Oral Morphine Equivalent (OME) from Baseline
Change in Pain Catastrophizing Score from Baseline
Change in Pain Intensity Score from Baseline
+1 moreSide effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
Participants will complete study procedures as follows:
* 2, in-clinic or remote, preparation sessions with therapists.
* In-clinic treatment session with therapists at Dana-Farber Cancer Institute. Participants will take a predetermined amount of psilocybin once. Participants will be transported home by a friend or family member.
* In-clinic integration session the day after psilocybin administration with therapists.
* In-clinic or remote, integration session with therapists 1 week after psilocybin administration.
* In-clinic or remote follow visits with therapists at week 2, 3, 5, 8, and 12 after psilocybin administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530
Find a Location
Who is running the clinical trial?
Yvan Beaussant, MD, MSciLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
Cy BiopharmaUNKNOWN
Pancreatic Cancer North AmericaUNKNOWN
Yvan Beaussant, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
15 Total Patients Enrolled