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Psychedelic Therapy

Psilocybin for Chronic Pain and Depression (TRANSCEND Trial)

Phase 2
Waitlist Available
Led By Muhammad Ishrat Husain, MBBS, MD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have a primary DSM-5 diagnosis of non-psychotic Major Depressive Disorder (MDD)
Must have a diagnosis of chronic neuropathic pain confirmed by a pain specialist
Must not have
Relative or absolute contraindications to psilocybin
Presence of specific cardiac conditions or risk factors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Summary

"This trial aims to see if using psilocybin, found in 'magic mushrooms', along with therapy can help adults with chronic nerve pain and depression that doesn't respond well to treatment. Previous studies

Who is the study for?
This trial is for adults with chronic nerve pain and depression that hasn't improved with standard treatments. Participants must be able to undergo psychotherapy sessions and take psilocybin safely.
What is being tested?
The study tests the effects of a single dose of Psilocybin (25 mg), combined with psychotherapy, on individuals suffering from long-term neuropathic pain and depression resistant to usual treatments.
What are the potential side effects?
Psilocybin can cause headaches, nausea, dizziness, changes in perception or mood swings during treatment. Long-term side effects are still being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with major depression without psychosis.
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My chronic pain has been confirmed as neuropathic by a specialist.
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I can take pills by mouth.
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My kidney function and blood work meet the required levels.
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I am between 18 and 65 years old and not hospitalized.
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I experience significant nerve pain.
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I have tried at least two medications for nerve pain without success.
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My depression hasn't improved with standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take psilocybin due to health risks.
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I have certain heart conditions or risks.
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I have been diagnosed with a psychiatric disorder defined in the DSM-5.
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I am currently taking certain medications.
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I have a history of heart rhythm problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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
Percentage of participants recruited, enrolled and retained (feasibility) and the number of serious adverse events and serious adverse drug reactions associated with administration of 25 mg of psilocybin (safety).
Secondary study objectives
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from Baseline to 1-week post-treatment.
Other study objectives
Change in Patient Reported Outcomes Measurement Information System- Pain Interference Scale (PROMIS-Interference) from Baseline to 1-week post-treatment.
Change in Patient Reported Outcomes Measurement Information System-Pain Intensity Scale (PROMIS-PI) from Baseline to 1-week post-treatment.

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 (25 mg)Experimental Treatment1 Intervention
One capsule of psilocybin 25 mg will be taken orally with a glass of water.

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
366 Previous Clinical Trials
82,320 Total Patients Enrolled
Muhammad Ishrat Husain, MBBS, MDPrincipal InvestigatorCentre for Addiction and Mental Health
1 Previous Clinical Trials
12 Total Patients Enrolled
~11 spots leftby Sep 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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