Health TrialsbyHealthPanel

Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN

ConditionsChronic Neuropathic PainPain Management
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUnity Health Toronto

About this trial

This is a feasibility study to examine the use of use of Psilocybin (magic mushrooms) to alleviate pain in chronic neuropathic pain.

While theoretical mechanisms demonstrate promise, there is no clinical evidence. This vacuum of clinical evidence has been occupied by a "psychedelic hype bubble" with media communications touting psychedelics as a 'miracle cures'. The mismatch between evidence and perception creates an urgent need for RCT to fill this significant gap. This trial aims to address this gap by conducting a pilot trial assessing the feasibility, tolerability, and preliminary efficacy of psilocybin for chronic neuropathic pain to inform a future larger, multi-centre study.

The purpose is to conduct a randomized control double-blinded trial of psilocybin and active placebo (dextromethorphan).

At this time, the aim of the trial is to recruit 30 participants from St. Michael's Hospital, to learn whether it will be feasible to plan a larger study in the future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-65 years of age

Diagnosis of chronic neuropathic pain as determined by a pain specialist

Moderate-to-severe neuropathic pain determined by Patient Reported Outcomes Measurement Information System (PROMIS)

Previous trials of at least two medications recommended in the Canadian consensus guidelines on the management of neuropathic pain with no self-reported meaningful improvement in symptoms

Disqualifiers

History of Dextromethorphan addiction or abuse.

Enzyme CYP2D6 deficient as shown on the pharmacogenetic test.

Underlying psychiatric conditions: lifetime or family history of a primary psychotic disorder, bipolar disorder, borderline personality disorder, paranoid personality disorder, current suicidal ideation, and substance use disorder within the past 12 months as assessed by history and confirmed by the Mini International Neuropsychiatric Interview (MINI)

Medications that interact with study drugs

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psilocybin

    Drug

    PSILOCYBIN (PEX010) 25 mg PO single dose

  • Active Placebo

    Drug

    Dextromethorphan 400 mg PO single dose

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Intervention Arm with PsilocybinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility to recruit 30 participants into a trial of psilocybin and active placebo to prepare for a larger multicentre trial

Recruitment rate and withdrawal rate (Acceptability and feasibility study)

Time frame
18 months

Secondary outcomes

1

Change in pain intensity from baseline to one month after interventions

Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS Pain Intensity, Pain intensity scale- 0 to 10 (The higher the number the higher the pain intensity)

Time frame
one month
2

Change in pain interference from baseline to one month after interventions

Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. Pain Interference, Pain interference scale- 6 items, 5 Likert scale (the higher the score the higher the interference from pain)

Time frame
one month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Unity Health Toronto

Lead sponsor

Source ClinicalTrials.gov
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