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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.

Must not have

Have moderate to severe hepatic impairment

Chronic pain is due to cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 33 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver is not working well.

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My chronic pain is caused by my cancer.

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I am not pregnant, planning to become pregnant, or breastfeeding during the study.

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I have had a stroke or a mini-stroke (TIA) in the past.

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I have a serious sleep disorder like sleep apnea that's not being treated.

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I have been diagnosed with a psychotic disorder, such as schizophrenia, major depression with psychosis, or bipolar disorder.

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I have a close family member with schizophrenia or bipolar disorder.

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I have epilepsy.

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I have a serious heart condition or abnormal heart test results.

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I require insulin to manage my diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 33 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of psilocybin administration

Feasibility of psilocybin administration

Safety of psilocybin administration

Secondary study objectives

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

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: 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.

0 / 18Eligibility criteria met