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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 below
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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.
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I've tried and failed to stop taking opioids before but want to try again.
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I am between 19 and 75 years old.
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I have been on a stable dose of opioid pain medication for at least 90 days.
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I have a long-term pain condition like nerve pain, fibromyalgia, chronic headaches, back pain, or muscle pain.
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I can swallow pills.
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I am between 19 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 33 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 33 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 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 • 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%
Pyrexia
2%
Oedema
2%
Vomiting
2%
Rhinorrhea
2%
Musculoskeletal pain
2%
Hypoesthesia
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

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
1,419 Previous Clinical Trials
2,467,158 Total Patients Enrolled
8 Trials studying Chronic Pain
662 Patients Enrolled for Chronic Pain
EntheoTech Bioscience Inc.UNKNOWN

Media Library

Psilocybin-assisted Psychotherapy (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05585229 — Phase 2
Chronic Pain Research Study Groups: Psilocybin-assisted Psychotherapy
Chronic Pain Clinical Trial 2023: Psilocybin-assisted Psychotherapy Highlights & Side Effects. Trial Name: NCT05585229 — Phase 2
Psilocybin-assisted Psychotherapy (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05585229 — Phase 2
Chronic Pain Patient Testimony for trial: Trial Name: NCT05585229 — Phase 2

Frequently Asked Questions

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

Does the upper age limit for this clinical trial include seniors?

"People aged 19 to 75 who meet the other inclusion criteria are eligible for this clinical trial. There are 592 trials for people over 65 and 51 trials for people under 18."

Answered by AI

Are there any opportunities for people to participate in this trial?

"This particular trial, which was posted on December 15th, 2022 and last updated October 14th, is no longer recruiting patients. However, there are 690 other active clinical trials that may be of interest."

Answered by AI

Who would be an eligible candidate for this research?

"In order to be selected for this experiment, hopefuls must suffer from chronic pain and fall between the ages of 19-75. Unfortunately, only 10 people will be able to participate."

Answered by AI

When will Psilocybin-assisted Psychotherapy be available to the general public?

"While there is some clinical evidence supporting the safety of Psilocybin-assisted Psychotherapy, it remains unproven whether or not the intervention is effective. Consequently, it received a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
West Virginia
Washington
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of British Columbia - Okanagan Campus
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I have tried several medications for pain. I am currently on hold from any pain reduction meds for an upcoming test. I will soon make a trip to Cleveland Clinic for a consultation for pain.
PatientReceived 1 prior treatment
I’ve been a long term relapsing user of opiates and opioid medications for 35 years. I have been sober from alcohol and other drugs for 9 years, however in those 9 years I’ve intermittently used opiates medications for pain control.
PatientReceived no prior treatments
I have had thirty years of chronic pain . I've done surgeries neck. knee, ankle, etc. I just keep getting more debilitated every day. I'm coming to a point where adult foster care will be my only option if I don't find an answer. I've only been diagnosed with fibromyalgia and am desperate to get choices back in my life.
PatientReceived 2+ prior treatments
I have had chronic back pain since 2001. I have never really used prescription drugs for it, but have suddenly lost my “tolerance” for this pain. It’s making me crazy. I’ve had an MRI in recent weeks which reflects a slight deterioration in physical condition inconsistent with the significant increase in pain. (Maybe I’m just getting old.).
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Would I have to come to Canada?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. University of British Columbia - Okanagan Campus: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication
W Francois Louw 2023. "Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05585229.
~6 spots leftby Feb 2025
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