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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

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

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 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Diarrhea

Influenza

Headache

Sinus headache

Depressed mood

Depression

Insomnia

Suicidal Ideation

Lower resp. tract congestion

Oropharyngeal pain

Alcohol withdrawal syndrome

Migraine

Thrombocytosis

Constipation

Vomiting

Oedema

Peripheral swelling

Pyrexia

Dermatitis contact

Bronchitis bacterial

Eye infection

Fungal infection

Traumatic lung injury

Hyponatremia

Arthralgia

Musculoskeletal pain

Pain in extremity

Malignant melanoma

Dizziness

Hypoesthesia

Sedation

Anger

Anxiety

Restlessness

Cough

Rhinorrhea

Sinus congestion

Sexual abuse

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

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

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