NCT05585229 Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication
| NCT ID | NCT05585229 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of British Columbia |
| Condition | Opioid Dependence |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 10 participants in total. It began in 2025-10-27 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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.
Contact & Investigator
W. Francois Louw, MD
PRINCIPAL INVESTIGATOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT05585229 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 75 Years, studying Opioid Dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05585229 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05585229 currently recruiting?
Yes, NCT05585229 is actively recruiting participants. Contact the research team at doclouw@mail.ubc.ca for enrollment information.
Where is the NCT05585229 trial being conducted?
This trial is being conducted at Kelowna, Canada.
Who is sponsoring the NCT05585229 clinical trial?
NCT05585229 is sponsored by University of British Columbia. The principal investigator is W. Francois Louw, MD at University of British Columbia. The trial plans to enroll 10 participants.