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New treatment option for Opioid Dependence
Official title Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication
ClinicalTrials.gov ID: NCT05585229
What this study is testing
What is Psilocybin-assisted Psychotherapy?
Psilocybin-assisted Psychotherapy is an investigational medicine, being studied as a potential treatment for opioid dependence.
Also referred to as PEX010.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 75
You may be able to join if
- 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...
- 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...
- History of at least one unsuccessful attempt to taper or discontinue long-term opioid therapy, and has expressed current interest in making another...
- Able to swallow capsules/tablets.
You likely can't join if
- Have any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac...
- Asthma
- Have moderate to severe hepatic impairment.
- Chronic pain is due to cancer.
- Women who are pregnant, who intend to become pregnant during the study, or who are currently breastfeeding.
- Have a history of stroke or Transient Ischemic Attack (TIA).
See the full eligibility criteria
- 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.
- Able to swallow capsules/tablets.
- If of childbearing potential, agree to practice an effective means of birth control throughout the duration of the study.
- 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...
- Asthma
- Have moderate to severe hepatic impairment.
- Chronic pain is due to cancer.
- Women who are pregnant, who intend to become pregnant during the study, or who are currently breastfeeding.
- Have a history of stroke or Transient Ischemic Attack (TIA).
- Meet DSM-5 criteria for severe alcohol or drug use disorders (other than Opioid use Disorder).
- Nicotine dependence that would prevent the participant from remaining nicotine free for the duration of dosing sessions (i.e., 6-8 hours).
- Have Epilepsy.
- Clinically significant sleep disorders such as sleep apnoea not on appropriate treatment.
- Have Insulin-dependent diabetes.
- 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)...
- 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).
- 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.
- Have a first degree relative with schizophrenia, Bipolar I or Bipolar II Disorder.
- Meet DSM-5 criteria for diagnosis of antisocial or borderline personality disorders.
- Participants with a history of a developmental disorder.
- Participants diagnosed with serious comorbidities that may or may not influence mental health in the opinion of the qualified investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Kelowna, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kelowna, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.