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Psychedelic Therapy

Psilocybin for Cancer Pain

Q: What is the regulatory status of Psilocybin in relation to governmental agencies?

<p>Our assessment of <a href="https://www.withpower.com/clinical-trials/psilocybin">psilocybin</a>'s safety was a 2, as the Phase 2 trial has provided initial evidence for its safety but not efficacy.</p>

Phase 2

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of Psilocybin-Assisted Therapy

Feasibility of Psilocybin-Assisted Therapy

Secondary outcome measures

Change in Oral Morphine Equivalent (OME) from Baseline

Change in Pain Catastrophizing Score from Baseline

Change in Pain Intensity Score from Baseline

+1 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Suicidal Ideation

Oropharyngeal pain

Insomnia

Influenza

Depression

Diarrhea

Headache

Sinus headache

Depressed mood

Lower resp. tract congestion

Alcohol withdrawal syndrome

Restlessness

Fungal infection

Pyrexia

Hypoesthesia

Oedema

Vomiting

Rhinorrhea

Musculoskeletal pain

Peripheral swelling

Thrombocytosis

Eye infection

Constipation

Dermatitis contact

Bronchitis bacterial

Traumatic lung injury

Hyponatremia

Arthralgia

Pain in extremity

Dizziness

Migraine

Sedation

Anger

Anxiety

Cough

Sexual abuse

Sinus congestion

Malignant melanoma

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

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

~730

Do I qualify?Apply below to find out

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

Frequently Asked Questions

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

What is the regulatory status of Psilocybin in relation to governmental agencies?

"Our assessment of psilocybin's safety was a 2, as the Phase 2 trial has provided initial evidence for its safety but not efficacy."

Answered by AI

Is the recruitment process for this trial open at present?

"Data hosted on clinicaltrials.gov reports that this research is no longer recruiting candidates, with the original posting occurring on January 1st 2024 and most recent update being August 14th 2023. Although there are not any openings for this trial, 2899 other studies are currently enrolling patients at present."

Answered by AI

What is the desired outcome of this clinical research?

"This clinical trial, estimated to take 3 weeks for completion, is primarily focused on understanding the acceptability of psilocybin-assisted therapy. The secondary outcomes will be assessing participants' pain catastrophizing scores from baseline using a 5-point scale; evaluating oral morphine equivalents at baseline and again post-dosing; and measuring changes in pain intensity score between pre and post dosing via the Brief Pain Inventory (BPI)-short which rates discomfort levels on a 0 to 10 numerical scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Psilocybin in Cancer Pain Study

Yvan Beaussant, MD, MSci 2024. "Psilocybin in Cancer Pain Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06001749.

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