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

Trial Summary

What is the purpose of 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.

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.

What data supports the effectiveness of psilocybin-assisted psychotherapy for opioid use disorder?

Research suggests that psilocybin, a psychedelic drug, may help reduce the odds of opioid use disorder. Studies have shown that people who have used psilocybin have lower chances of developing this disorder, indicating its potential as a treatment option. ^{1 2 3 4 5}

Is psilocybin-assisted therapy generally safe for humans?

Research suggests that psilocybin-assisted therapy is generally safe when administered under medical supervision, with most side effects being mild and temporary. However, there have been some reports of increased suicidal thoughts and self-injurious behaviors, indicating the need for further study to understand who might be at risk for these adverse effects. ^{1 3 6 7 8}

How is psilocybin-assisted psychotherapy different from other treatments for opioid use disorder?

Psilocybin-assisted psychotherapy is unique because it combines the use of psilocybin, a psychedelic compound, with psychotherapy to potentially reduce opioid use disorder. Unlike traditional treatments, it may offer longer-term positive effects after just one or a few doses, and it works by influencing psychological experiences under medical supervision. ^{1 3 4 5 9}

Research Team

W. Francois Louw, MD

Principal Investigator

University of British Columbia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Psilocybin-Assisted Treatment of Depression, Anxiety and Substance use Disorders: Neurobiological Basis and Clinical Application]. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Psychedelic Debriefing in Alcohol Dependence Treatment: Illustrating Key Change Phenomena through Qualitative Content Analysis of Clinical Sessions. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

The association of psychedelic use and opioid use disorders among illicit users in the United States. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Associations between classic psychedelics and opioid use disorder in a nationally-representative U.S. adult sample. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring psilocybin-assisted psychotherapy in the treatment of methamphetamine use disorder. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Psilocybin-Assisted Therapy: A Review of a Novel Treatment for Psychiatric Disorders. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Optimal dosing for psilocybin pharmacotherapy: Considering weight-adjusted and fixed dosing approaches. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Psilocybin history, action and reaction: A narrative clinical review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Psychedelic therapy for smoking cessation: Qualitative analysis of participant accounts. [2019]