Actively Recruiting

Phase 2
Age: 19Years - 75Years
All Genders
NCT05585229

Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication

Led by University of British Columbia · Updated on 2025-12-04

10

Participants Needed

1

Research Sites

44 weeks

Total Duration

On this page

Sponsors

U

University of British Columbia

Lead Sponsor

E

Etheridge Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication

Who Can Participate

Age: 19Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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).
  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of British Columbia - Okanagan Campus

Kelowna, British Columbia, Canada, V1V 1V7

Actively Recruiting

Loading map...

Research Team

W

W. Francois Louw, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here