Psilocybin-assisted psychotherapy to help taper long-term opioid pain medicines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, 8-week pilot intervention with one or two supervised psilocybin dosing sessions combined with preparatory and integration psychotherapy using an acceptance and commitment therapy model. The first dosing session (25 mg) is followed by an integration session and a physician-supervised opioid taper, with an optional second dosing (37.5 mg) about one month later. Safety, tolerability, retention, and patient-reported benefits and harms will be tracked, and opioid dose reductions will be measured at 1, 3, and 6 months after the intervention. The study enrolls adults with chronic noncancer pain on stable long-term opioid therapy who have previously been unable to taper and have no contraindications to psilocybin.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of British Columbia - Okanagan Campus
  Kelowna, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: W. Francois Louw, MD — University of British Columbia
• Study coordinator: W. Francois Louw, MD
• Email: doclouw@mail.ubc.ca
• Phone: 250-860-9754

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Safer pain treatment options for cancer survivors on long-term opioids

  This project will try four different approaches to lower long-term opioid use while keeping pain controlled in Veterans who are cancer survivors on chronic opioid therapy.

  Recruiting Phase 4 VA Office of Research and Development · Indianapolis, Indiana and 1 other locations · NCT06574009

• Program to reduce opioid use in chronic pain patients after surgery

  This study is testing a new program to help chronic pain patients use less opioids after surgery by providing pain education and support tools.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT03675386

• Cognitive Rehabilitation of Everyday Goals With GMT: How Different Ways of Delivery Work

  This study tests Goal Management Training to see if a Swedish version helps adults with acquired brain injury or chronic pain improve practical goal-directed thinking and daily functioning.

  Recruiting at 2 sites Karolinska Institutet · Luleå, Norrbotten County and 2 other locations · NCT07924774

• One-time Pain Reprocessing Therapy session for chronic pain at The Ottawa Hospital

  A single four-hour session of Pain Reprocessing Therapy is being tested to see if it can help adults with chronic pain feel better and have less pain.

  Recruiting Ottawa Hospital Research Institute · Ottawa, Ontario · NCT07919626

• Meaning-Based Psychotherapy for Adults with Chronic Pain

  This trial tests whether Meaning-Based Psychotherapy helps adults with chronic pain feel more purposeful, feel less depressed, and have a better quality of life compared with optimized usual care therapy.

  Recruiting Hospital Clinico Universitario San Cecilio · Granada, Granada · NCT07915440

• How chronic pain changes over time in kids with Duchenne Muscular Dystrophy

  This study is following children and teens with Duchenne Muscular Dystrophy for 6 months to see how their chronic pain changes and how it affects daily life.

  Recruiting Antalya Training and Research Hospital · Antalya, Antalya · NCT07892196

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.