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
Qualifiers
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
Treatments tested in this trial
- Psilocybin-assisted Psychotherapy
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
University of British Columbia
Lead sponsor
Etheridge Foundation
Collaborator
Source ClinicalTrials.gov