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Psychedelic

Psilocybin for Phantom Limb Pain

Phase 1
Recruiting
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between 18 and 75 years of age
Amputation of one extremity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to post-intervention session (within 2 weeks after session)
Awards & highlights

Study Summary

This trial is investigating whether psilocybin, a compound found in some mushrooms, can be safely given to people with chronic pain in their amputated limbs, and if it can help relieve their pain.

Who is the study for?
Adults aged 18-75 with one amputated extremity and chronic phantom limb pain for at least a month, not using certain medications or substances, can join this trial. They must be stable on any analgesics used, agree to birth control if applicable, and have transportation post-session. Excluded are those with severe mental health risks, specific medication use, cardiovascular issues, multiple amputations or other chronic pains.Check my eligibility
What is being tested?
This study tests whether psilocybin can safely reduce pain in people with phantom limb pain when given in a controlled environment. Participants will either receive psilocybin or a placebo (niacin) without knowing which one they get. The effects on pain levels as well as mood and behavior changes will be monitored.See study design
What are the potential side effects?
While the study aims to ensure safety, potential side effects of psilocybin may include nausea, headache, increased heart rate and blood pressure changes shortly after taking it; psychological effects like anxiety or altered perception during the experience.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I have had an amputation of one limb.
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I have had phantom limb pain for over a month with a pain level of at least 3 out of 10.
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I am willing to stop taking serotonergic antidepressants for the study.
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I am between 18 and 75 years old.
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I have had an amputation of one limb.
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I have had phantom limb pain for over a month with a pain level of at least 3 out of 10.
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I am willing to stop taking serotonergic antidepressants for the study.
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I can stay in an MRI machine without needing sedation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to post-intervention session (within 2 weeks after session)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to post-intervention session (within 2 weeks after session) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Phantom Limb Pain Intensity
Secondary outcome measures
Brief Pain Inventory
Cerebral Blood Flow (CBF)
Change in Visual Analog Scale Pain ratings

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%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PsilocybinExperimental Treatment1 Intervention
Participants will receive 25mg oral psilocybin one day to two weeks after baseline psychophysical and fMRI testing. Psychophysical and fMRI testing will then be employed one day to two weeks after drug administration.
Group II: NiacinPlacebo Group1 Intervention
Participants will receive 100mg oral niacin one day to two weeks after baseline psychophysical and fMRI testing. Psychophysical and fMRI testing will then be employed one day to two weeks after drug administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
Not yet FDA approved

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,387 Total Patients Enrolled

Frequently Asked Questions

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

Are participants over 25 years old eligible to join this experiment?

"This clinical trial stipulates that participants must be aged 18 and above, with a maximum age limit of 75."

Answered by AI

Are there any open enrolment opportunities at present for this research experiment?

"Unfortunaltely, it appears that this trial is not currently accepting new patients. According to clinicaltrials.gov, the last edit was on January 24th and initial posting occurred on March 1st 2022. Despite its closed status, 27 other medical trials are actively recruiting candidates at present time."

Answered by AI

Is there any hazard associated with the usage of Psilocybin?

"Our assessment of the safety profile for Psilocybin is rated at 1 due to this being a Phase 1 trial, which means that there is only sparse evidence demonstrating its efficacy and security."

Answered by AI

Am I an eligible participant for this research initiative?

"The trial is presently recruiting 20 individuals aged 18-75 suffering from pain. Prospective participants must adhere to the following criteria: abstain from serotonergic drug use, renounce all nonprescription drugs and supplements before each session unless otherwise permitted by the research team, communicate in English fluently, sign consent forms and HIPPA authorizations, reject psychoactive substances aside from alcohol 24 hours prior/following administration of study drug, stay away from nicotine 8am - discharge time on test days, tolerate MRIs without sedation."

Answered by AI

Who else is applying?

What state do they live in?
Montana
Indiana
California
How old are they?
18 - 65
What site did they apply to?
University of California, San Diego
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Excited to see the world finally looking into mushrooms medicinal properties. Would love to be apart of this trail.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. University of California, San Diego: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Psilocybin-assisted Therapy for Phantom Limb Pain
Fadel Zeidan 2022. "Psilocybin-assisted Therapy for Phantom Limb Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05224336.
~1 spots leftby Jun 2024
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