Overview

Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication

Status:
Not yet recruiting
Trial end date:
2023-12-15
Target enrollment:
0
Participant gender:
All
Summary
This is an open-label pilot trial to assess the safety and feasibility of a novel 6-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 two 25mg psilocybin-assisted psychotherapy 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of British Columbia
Collaborator:
EntheoTech Bioscience Inc.
Treatments:
Psilocybin
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.