Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication

November 26, 2025 updated by: W Francois Louw, University of British Columbia

Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication in Patients With Chronic Pain: an Open-label Feasibility Study

This is an open-label pilot trial to assess the safety and feasibility of a novel 8-week psilocybin-assisted psychotherapy intervention to facilitate successful tapering/discontinuation of opioid pain medication in adult patients receiving long-term opioid therapy for chronic pain. Participation will last approximately 8 months and includes one or two psilocybin-assisted therapy sessions. The study will evaluate the incidence and severity of adverse events during and after treatment, the number of participants who drop out of the study for intervention-related reasons, and the self-reported benefits and harms of the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this pilot study is to establish the safety and tolerability of a therapeutic intervention using psilocybin-assisted psychotherapy as a novel treatment for opioid tapering in a sample of patients with chronic pain. Participants will be patients who have failed previous attempts to reduce their use of opioid medication and who have no medical or psychological contraindications for psilocybin administration.

This pilot study involves an 8-week open-label, non-randomized therapeutic intervention and a 6-month follow-up period. To provide a supportive context for the drug experience, participants will receive preparatory and integrative sessions following an acceptance and commitment therapy model for psychedelic therapy. The physician-supervised opioid taper will begin following the first psilocybin dosing session (25mg) after an integration session with therapists, and a second optional psilocybin dosing session (37.5mg) will be facilitated one month later. Assessments will be completed at baseline, and at follow-up points at 1-month, 3-months and 6-months post-intervention to evaluate both acute and long-term effects of the intervention.

Primary outcomes of interest are rates of adverse events, retention rates, and patient perceptions of intervention tolerability. Preliminary efficacy of the treatment will be evaluated by tracking opioid reduction rates and long-term maintenance of these reductions. Other measures of interest include qualities of the psychedelic experience, opioid cravings and withdrawal, chronic pain symptoms, and psychological mechanisms.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1V 1V7
        • Recruiting
        • University of British Columbia - Okanagan Campus
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Must be 19 - 75 years of age.
  2. Have a diagnosed noncancer chronic pain condition including but not limited to neuropathic pain, fibromyalgia, chronic headaches/migraines, back pain, musculoskeletal pain.
  3. 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.
  4. History of at least one unsuccessful attempt to taper or discontinue long-term opioid therapy, and has expressed current interest in making another attempt to reduce or discontinue.
  5. Able to swallow capsules/tablets.
  6. If of childbearing potential, agree to practice an effective means of birth control throughout the duration of the study.

Exclusion Criteria:

  1. Have any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, greater than first degree AV block, cardiac ischemia, congestive heart failure, myocardial infarction, tachycardia, chronic bradycardia, artificial heart valve, a clinically significant screening ECG abnormality, or any other significant cardiovascular condition.
  2. Asthma
  3. Have moderate to severe hepatic impairment.
  4. Chronic pain is due to cancer.
  5. Women who are pregnant, who intend to become pregnant during the study, or who are currently breastfeeding.
  6. Have a history of stroke or Transient Ischemic Attack (TIA).
  7. Meet DSM-5 criteria for severe alcohol or drug use disorders (other than Opioid use Disorder).
  8. Nicotine dependence that would prevent the participant from remaining nicotine free for the duration of dosing sessions (i.e., 6-8 hours).
  9. Have Epilepsy.
  10. Clinically significant sleep disorders such as sleep apnoea not on appropriate treatment.
  11. Have Insulin-dependent diabetes.
  12. Participants who are or have been taking mood stabilizers (e.g. lithium), SSRIs/SNRIs (e.g. citalopram, venlafaxine, vortioxetine, duloxetine), herbal remedies with serotonin activity (e.g. 5-HTP, St. John's Wort), dopamine agonists (e.g. bupropion), tricyclic antidepressants (e.g. amitriptyline), antipsychotics (e.g. haloperidol), amphetamines (e.g. amphetamine/dextroamphetamine salts, methylphenidate, dextroamphetamine, lisdexamfetamine), monoamine oxidase inhibitors (e.g. isocarboxazid, phenelzine, selegiline, tranylcypromine), alcohol or aldehyde dehydrogenase inhibitors (e.g. disulfiram), and UDG modulators (i.e. UGT modulators such as phenytoin, regorafenib, eltrombopag) during the study or in the preceding 8 weeks.
  13. Hallucinogenic or psychedelic drug use within 12 months (i.e. any use of mescaline, 2C-B, psilocybin, LSD, 5-MeO-DMT, ibogaine ayahuasca, MDA, MDMA, ketamine or any related molecules).
  14. Meet DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features, or Bipolar I or Bipolar II Disorder.
  15. Have a first degree relative with schizophrenia, Bipolar I or Bipolar II Disorder.
  16. Meet DSM-5 criteria for diagnosis of antisocial or borderline personality disorders.
  17. Participants with a history of a developmental disorder.
  18. Participants diagnosed with serious comorbidities that may or may not influence mental health in the opinion of the qualified investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Psilocybin-assisted Psychotherapy
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.
Drug: Psilocybin-assisted Psychotherapy
Participants will complete a 8-week structured psychotherapeutic intervention involving administration of 25mg and 37.5mg PEX010 on two separate occasions.
Other Names:
  • PEX010

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety of psilocybin administration
Time Frame: Up to 33 Weeks
Number and type of treatment-related adverse events and serious adverse events reported during the intervention.
Up to 33 Weeks
Feasibility of psilocybin administration
Time Frame: Week 31
Percentage of participants who provide consent and complete the intervention.
Week 31
Acceptability of psilocybin administration
Time Frame: Week 31
Participant ratings of benefits and harms of the intervention.
Week 31

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in prescribed opioid dose at the 1-month visit compared to initial dose
Time Frame: Week 11
Taper adherence rates will be assessed by categorizing participants as "adhering", or "non-adhering" based on percentage of the initial dose that they are using at the 1-month timepoint.
Week 11
Change in prescribed opioid dose at the 3-month visit compared to initial dose
Time Frame: Week 19
Taper adherence rates will be assessed by categorizing participants as "adhering", or "non-adhering" based on percentage of the initial dose that they are using at the 3-month timepoint.
Week 19
Change in prescribed opioid dose at the 6-month visit compared to initial dose
Time Frame: Week 31
At 6-month follow-up participants will be categorized as "successful" if they have discontinued opioid therapy, and "unsuccessful" if they have not.
Week 31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Etheridge Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: W. Francois Louw, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PsilOps

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings