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Psychedelic
Psilocybin-assisted Psychotherapy for Opioid Use Disorder
Phase 2
Waitlist Available
Led By W. Francois Louw, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a diagnosed noncancer chronic pain condition including but not limited to neuropathic pain, fibromyalgia, chronic headaches/migraines, back pain, musculoskeletal pain.
Currently on a stable dose of opioid therapy on short-acting, long-acting, or combination of opioid medication types, for a minimum duration of 90 consecutive days.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 33 weeks
Awards & highlights
Study Summary
This trial tests if a type of psychedelic therapy can help people reduce their opioid use for chronic pain. Participation lasts 8 months and includes two 25mg psilocybin therapy sessions. Outcomes will be tracked for safety & effectiveness.
Who is the study for?
Adults aged 19-75 with chronic non-cancer pain, on stable opioid therapy for at least 90 days, who have tried and failed to taper off opioids before. Participants must be able to swallow pills and if capable of childbearing, agree to use birth control during the study. Excluded are those with nicotine dependence, epilepsy, severe sleep or mental health disorders, certain heart conditions or liver impairment, pregnant/breastfeeding women, recent users of hallucinogens or certain medications.Check my eligibility
What is being tested?
The trial is testing an 8-week psilocybin-assisted psychotherapy program designed to help adults reduce or stop their long-term opioid medication for chronic pain. It includes one or two sessions with psilocybin (active ingredient in magic mushrooms) alongside talk therapy over about eight months.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects from similar treatments may include temporary anxiety or panic related to psychedelic experiences during dosing sessions; changes in mood; headaches; nausea; increased blood pressure and heart rate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a long-term pain condition like nerve pain or chronic back pain.
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I have been on a stable opioid dose for at least 90 days.
Select...
I've tried and failed to stop taking opioids before but want to try again.
Select...
I am between 19 and 75 years old.
Select...
I have been on a stable dose of opioid pain medication for at least 90 days.
Select...
I have a long-term pain condition like nerve pain, fibromyalgia, chronic headaches, back pain, or muscle pain.
Select...
I can swallow pills.
Select...
I am between 19 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 33 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 33 weeks
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 administration
Feasibility of psilocybin administration
Safety of psilocybin administration
Secondary outcome measures
Change in prescribed opioid dose at the 1-month visit compared to initial dose
Change in prescribed opioid dose at the 3-month visit compared to initial dose
Change in prescribed opioid dose at the 6-month visit compared to initial dose
Side 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%
Suicidal Ideation
4%
Influenza
4%
Oropharyngeal pain
4%
Insomnia
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Pyrexia
2%
Oedema
2%
Vomiting
2%
Rhinorrhea
2%
Fungal infection
2%
Musculoskeletal pain
2%
Hypoesthesia
2%
Peripheral swelling
2%
Restlessness
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
1Treatment groups
Experimental Treatment
Group I: Psilocybin-assisted PsychotherapyExperimental Treatment1 Intervention
Participants will undergo a single-arm, 8-week therapeutic intervention using natural standardized psilocybin-assisted psychotherapy as a treatment for opioid tapering in chronic pain patients. Specifically, they will undergo one or two standardized natural psilocybin (PEX010) dosing sessions; 25mg at week 3 and 37.5mg at week 7.
Find a Location
Who is running the clinical trial?
Etheridge FoundationUNKNOWN
2 Previous Clinical Trials
66 Total Patients Enrolled
1 Trials studying Chronic Pain
56 Patients Enrolled for Chronic Pain
University of British ColumbiaLead Sponsor
1,422 Previous Clinical Trials
2,468,250 Total Patients Enrolled
8 Trials studying Chronic Pain
662 Patients Enrolled for Chronic Pain
EntheoTech Bioscience Inc.UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious sleep disorder like sleep apnea that's not being treated.I can swallow pills.I have been on a stable opioid dose for at least 90 days.I've tried and failed to stop taking opioids before but want to try again.My chronic pain is caused by my cancer.I am not pregnant, planning to become pregnant, or breastfeeding during the study.I have not taken any mood stabilizers, antidepressants, or similar drugs in the last 8 weeks.I have been diagnosed with a psychotic disorder, such as schizophrenia, major depression with psychosis, or bipolar disorder.I have been on a stable dose of opioid pain medication for at least 90 days.I have a long-term pain condition like nerve pain or chronic back pain.You have a very serious problem with alcohol or drugs, as defined by the DSM-5. This does not include an opioid use disorder.You are unable to stay away from nicotine for 6-8 hours during the study.You have used drugs like LSD, MDMA, or ketamine in the past year.You have a history of a developmental disorder.You have serious health conditions that may or may not affect your mental well-being, as determined by the study doctor.I have asthma.I am between 19 and 75 years old.I've tried and failed to stop or reduce my long-term opioid use but want to try again.I have had a stroke or a mini-stroke (TIA) in the past.My liver is not working well.You have been diagnosed with antisocial or borderline personality disorders according to the DSM-5.I have a long-term pain condition like nerve pain, fibromyalgia, chronic headaches, back pain, or muscle pain.I have a close family member with schizophrenia or bipolar disorder.I can swallow pills.I am between 19 and 75 years old.I have epilepsy.I have a serious heart condition or abnormal heart test results.I require insulin to manage my diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Psilocybin-assisted Psychotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Pain Patient Testimony for trial: Trial Name: NCT05585229 — Phase 2
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