Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-75
SponsorUniversity of British Columbia
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Psilocybin-assisted Psychotherapy
DrugParticipants will complete a 8-week structured psychotherapeutic intervention involving administration of 25mg and 37.5mg PEX010 on two separate occasions.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Psilocybin-assisted PsychotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of psilocybin administration
Percentage of participants who provide consent and complete the intervention.
Time frame
Week 312
Acceptability of psilocybin administration
Participant ratings of benefits and harms of the intervention.
Time frame
Week 313
Safety of psilocybin administration
Number and type of treatment-related adverse events and serious adverse events reported during the intervention.
Time frame
Up to 33 WeeksSecondary outcomes
1
Change in prescribed opioid dose at the 1-month visit compared to initial dose
Taper adherence rates will be assessed by categorizing participants as "adhering", or "non-adhering" based on percentage of the initial dose that they are using at the 1-month timepoint.
Time frame
Week 112
Change in prescribed opioid dose at the 3-month visit compared to initial dose
Taper adherence rates will be assessed by categorizing participants as "adhering", or "non-adhering" based on percentage of the initial dose that they are using at the 3-month timepoint.
Time frame
Week 193
Change in prescribed opioid dose at the 6-month visit compared to initial dose
At 6-month follow-up participants will be categorized as "successful" if they have discontinued opioid therapy, and "unsuccessful" if they have not.
Time frame
Week 31Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of British Columbia
Lead sponsor
Etheridge Foundation
Collaborator
Source ClinicalTrials.gov