Psilocybin-assisted Psychotherapy for Opioid Use Disorder

Overseen By W. Francois Louw, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of British Columbia

Must be taking: Opioid therapy

Must not be taking: Antidepressants, Antipsychotics, Amphetamines, others

Disqualifiers: Cardiovascular conditions, Asthma, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

10 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 4 6}

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

I can swallow pills.

I have been on a stable opioid dose for at least 90 days.

I've tried and failed to stop taking opioids before but want to try again.

Exclusion Criteria

I have a serious sleep disorder like sleep apnea that's not being treated.

My chronic pain is caused by my cancer.

I am not pregnant, planning to become pregnant, or breastfeeding during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week psilocybin-assisted psychotherapy intervention for opioid tapering, including one or two psilocybin dosing sessions

8 weeks

1-2 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

6 months

Assessments at 1-month, 3-months, and 6-months

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin-assisted Psychotherapy

Trial Overview

The trial is testing an 8-week psilocybin-assisted psychotherapy program designed to help adults reduce or stop their long-term opioid medication for chronic pain. It includes one or two sessions with psilocybin (active ingredient in magic mushrooms) alongside talk therapy over about eight months.

How Is the Trial Designed?

Group I: Psilocybin-assisted Psychotherapy Experimental Treatment 1 Intervention

Participants will undergo a single-arm, 8-week therapeutic intervention using natural standardized psilocybin-assisted psychotherapy as a treatment for opioid tapering in chronic pain patients. Specifically, they will undergo one or two standardized natural psilocybin (PEX010) dosing sessions; 25mg at week 3 and 37.5mg at week 7.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Etheridge Foundation

Collaborator

Trials

3

Recruited

50+

EntheoTech Bioscience Inc.

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

Lifetime use of psilocybin is associated with significantly lower odds of developing opioid use disorder (OUD), with an adjusted odds ratio of 0.70 based on a large sample of 214,505 participants from the National Survey on Drug Use and Health.

Psilocybin use was linked to reduced odds of meeting seven out of eleven DSM-IV criteria for OUD, suggesting its potential as a therapeutic option, although further clinical trials are necessary to establish a causal relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between classic psychedelics and opioid use disorder in a nationally-representative U.S. adult sample. Jones, G., Ricard, JA., Lipson, J., et al.[2022]

In a pilot study involving 15 participants, those who underwent psilocybin-facilitated smoking cessation reported significant insights into their self-identity and reasons for smoking, which contributed to their ability to quit smoking.

Participants experienced lasting positive changes beyond smoking cessation, such as increased altruism and pro-social behavior, suggesting that the therapeutic effects of psilocybin may extend beyond the immediate treatment context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychedelic therapy for smoking cessation: Qualitative analysis of participant accounts. Noorani, T., Garcia-Romeu, A., Swift, TC., et al.[2019]

Methamphetamine use disorder is a serious condition with high relapse rates and limited effectiveness of current treatments, highlighting the need for new therapeutic options.

Psilocybin-assisted psychotherapy shows promise as a potential treatment for methamphetamine use disorder, based on early experiences from four clinical trials, although no published studies currently exist on this specific application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring psilocybin-assisted psychotherapy in the treatment of methamphetamine use disorder. Brett, J., Knock, E., Korthuis, PT., et al.[2023]

Citations

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Preliminary findings suggest that psilocybin may help reduce opioid cravings by agonism at serotonergic receptors, particularly 5-HT2A, and to a lesser extent, ...

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NCT05585229 | Standardized Natural Psilocybin-assisted ...

Preliminary efficacy of the treatment will be evaluated by tracking opioid reduction rates and long-term maintenance of these reductions. Other measures of ...

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