Psilocybin-assisted Psychotherapy for Opioid Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a unique therapy that combines psilocybin (a compound found in certain mushrooms) with psychotherapy to help individuals reduce or stop using opioid pain medications. The goal is to determine if this approach is safe and effective in helping patients taper off opioids, particularly those with chronic pain conditions like fibromyalgia or back pain. Participants will undergo one or two therapy sessions involving psilocybin over eight weeks, with researchers monitoring for side effects and overall effectiveness. This trial may suit individuals on stable opioid therapy for at least three months who have previously tried unsuccessfully to reduce or stop their opioid use. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking therapy development.
Do I need to stop taking my current medications to join the trial?
Yes, you will need to stop taking certain medications, including mood stabilizers, SSRIs/SNRIs, herbal remedies with serotonin activity, dopamine agonists, tricyclic antidepressants, antipsychotics, amphetamines, monoamine oxidase inhibitors, alcohol or aldehyde dehydrogenase inhibitors, and UDG modulators, for at least 8 weeks before joining the study.
Is there any evidence suggesting that psilocybin-assisted psychotherapy is likely to be safe for humans?
Research has shown that psilocybin-assisted therapy may help reduce opioid and nicotine use. In studies on substance use disorders (SUD), psilocybin therapy improved symptoms. Although results varied for other types of SUDs, psilocybin has generally been helpful.
This trial is in an early stage, so researchers are carefully testing psilocybin for side effects. Early studies often focus on safety, so researchers are likely assessing how well people tolerate psilocybin and any possible negative effects.
In summary, while psilocybin-assisted therapy appears promising, its safety is still under investigation. Researchers are testing it to ensure it is safe and well-tolerated by participants.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for opioid use disorder, which often involve medications like methadone or buprenorphine, psilocybin-assisted psychotherapy uses a unique approach by incorporating the active ingredient psilocybin. Psilocybin is a naturally occurring psychedelic compound that targets serotonin receptors in the brain, potentially offering a new way to address the psychological aspects of addiction. Researchers are excited about this treatment because it has the potential to facilitate profound psychological insights and emotional breakthroughs, which might help patients address the root causes of their addiction more effectively. Additionally, the therapy is designed to work with just one or two sessions, possibly providing faster results compared to traditional methods that require ongoing treatment.
What evidence suggests that psilocybin-assisted psychotherapy might be an effective treatment for opioid use disorder?
Research has shown that psilocybin, a compound in certain mushrooms, may aid people with substance use disorders, such as opioid addiction. In this trial, participants will receive psilocybin-assisted psychotherapy for opioid tapering. Some studies suggest that psilocybin, when combined with therapy, might reduce opioid cravings by affecting specific brain areas related to mood and perception. Early results indicate it could help reduce opioid use, although results for other addictions remain mixed. While further research is necessary, these initial findings offer hope for those facing opioid use challenges.12346
Who Is on the Research Team?
W. Francois Louw, MD
Principal Investigator
University of British Columbia
Are You a Good Fit for This Trial?
Adults aged 19-75 with chronic non-cancer pain, on stable opioid therapy for at least 90 days, who have tried and failed to taper off opioids before. Participants must be able to swallow pills and if capable of childbearing, agree to use birth control during the study. Excluded are those with nicotine dependence, epilepsy, severe sleep or mental health disorders, certain heart conditions or liver impairment, pregnant/breastfeeding women, recent users of hallucinogens or certain medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo an 8-week psilocybin-assisted psychotherapy intervention for opioid tapering, including one or two psilocybin dosing sessions
Follow-up
Participants are monitored for safety, efficacy, and long-term effects of the intervention, with assessments at 1-month, 3-months, and 6-months post-intervention
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin-assisted Psychotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
Etheridge Foundation
Collaborator
EntheoTech Bioscience Inc.
Collaborator