Opioid DependencePhase 2NCT05585229
Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication
A Phase 2 study testing Psilocybin-assisted Psychotherapy in people with Opioid Dependence and Chronic Pain, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Opioid Dependence, Chronic Pain
- What is being tested?
- Psilocybin-assisted Psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 27 Oct 2025to 31 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 19 - 75 years of age.
- 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.
- 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.
- Able to swallow capsules/tablets.
- If of childbearing potential, agree to practice an effective means of birth control throughout the duration of the study.
Who cannot join
- 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.
- Asthma
- Have moderate to severe hepatic impairment.
- Chronic pain is due to cancer.
- Women who are pregnant, who intend to become pregnant during the study, or who are currently breastfeeding.
- Have a history of stroke or Transient Ischemic Attack (TIA).
Show all 18Show fewer
- Meet DSM-5 criteria for severe alcohol or drug use disorders (other than Opioid use Disorder).
- Nicotine dependence that would prevent the participant from remaining nicotine free for the duration of dosing sessions (i.e., 6-8 hours).
- Have Epilepsy.
- Clinically significant sleep disorders such as sleep apnoea not on appropriate treatment.
- Have Insulin-dependent diabetes.
- 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.
- 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).
- 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.
- Have a first degree relative with schizophrenia, Bipolar I or Bipolar II Disorder.
- Meet DSM-5 criteria for diagnosis of antisocial or borderline personality disorders.
- Participants with a history of a developmental disorder.
- Participants diagnosed with serious comorbidities that may or may not influence mental health in the opinion of the qualified investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia - Okanagan Campus
Kelowna, British Columbia, V1V 1V7
W. Francois Louw, MD, 250-860-9754, doclouw@mail.ubc.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid Dependence, Chronic Pain
- Being tested
- Psilocybin-assisted Psychotherapy
- Keywords
- Opioid Tapering, Psilocybin, Psychotherapy, Chronic Pain, Hallucinogens, Opioid Use Disorder
- Medical subject headings
- Opioid-Related Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin-assisted PsychotherapyDrug
Also called PEX010
Participants will complete a 8-week structured psychotherapeutic intervention involving administration of 25mg and 37.5mg PEX010 on two separate occasions.
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin-assisted Psychotherapy | Experimental | 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. Receives: Drug: Psilocybin-assisted Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of psilocybin administration
Percentage of participants who provide consent and complete the intervention.
Measured: Week 31
Acceptability of psilocybin administration
Participant ratings of benefits and harms of the intervention.
Measured: Week 31
Safety of psilocybin administration
Number and type of treatment-related adverse events and serious adverse events reported during the intervention.
Measured: Up to 33 Weeks
Secondary outcomes (3)
Change in prescribed opioid dose at the 1-month visit compared to initial dose
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.
Measured: Week 11
Change in prescribed opioid dose at the 3-month visit compared to initial dose
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.
Measured: Week 19
Change in prescribed opioid dose at the 6-month visit compared to initial dose
At 6-month follow-up participants will be categorized as "successful" if they have discontinued opioid therapy, and "unsuccessful" if they have not.
Measured: Week 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start27 Oct 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Etheridge Foundation
- Responsible party
- Principal investigator, W Francois Louw, University of British Columbia
- Investigators
- W. Francois Louw, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585229
- Sponsor's protocol ID
- PsilOps
- Status last verified
- Nov 2025
- First submitted
- 14 Oct 2022
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication in Patients With Chronic Pain: an Open-label Feasibility Study
- ClinicalTrials.gov ID
- NCT05585229
- Acronym / sponsor ID
- PsilOps
- Conditions
- Opioid Dependence, Chronic Pain
- Keywords
- Opioid Tapering, Psilocybin, Psychotherapy, Chronic Pain, Hallucinogens, Opioid Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Etheridge Foundation
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psilocybin-assisted Psychotherapy | Experimental | Drug: Psilocybin-assisted PsychotherapyParticipants 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. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be 19 - 75 years of age.
- 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.
- 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.
- Able to swallow capsules/tablets.
Key exclusion criteria (18 listed)
- 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.
- Asthma
- Have moderate to severe hepatic impairment.
- Chronic pain is due to cancer.
- Women who are pregnant, who intend to become pregnant during the study, or who are currently breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin-assisted PsychotherapyAlso: PEX010Participants will complete a 8-week structured psychotherapeutic intervention involving administration of 25mg and 37.5mg PEX010 on two separate occasions. | Drug | Psilocybin-assisted Psychotherapy |
Primary outcome
Feasibility of psilocybin administration
Time frame: Week 31
Percentage of participants who provide consent and complete the intervention.
Acceptability of psilocybin administration
Time frame: Week 31
Participant ratings of benefits and harms of the intervention.
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.
3 secondary outcomes
Change in prescribed opioid dose at the 1-month visit compared to initial dose
Time frame: Week 11
Change in prescribed opioid dose at the 3-month visit compared to initial dose
Time frame: Week 19
Change in prescribed opioid dose at the 6-month visit compared to initial dose
Time frame: Week 31
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
W. Francois Louw, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin-assisted Psychotherapy in people with Opioid Dependence and Chronic Pain, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact W. Francois Louw, MD (250-860-9754, doclouw@mail.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of psilocybin administration (time frame: Week 31). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.