Psilocybin-Assisted Psychotherapy for Cannabis Use Disorder

(PSI_CUD Trial)

Overseen By Maryam Rahat, Ph.D Candiate

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: McMaster University

Must not be taking: Stimulants, Antipsychotics, Benzodiazepines, others

Disqualifiers: Bipolar, Schizophrenia, Panic, 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: Unknown

Duration: 8 weeks

16 Participants Needed

Trial Summary

What is the purpose of this trial?

Cannabis is the most commonly used psychoactive substance in Canada (Lowry \& Corsi, 2020). A sub-group of cannabis users develop a condition known as Cannabis Use Disorder (CUD), which is defined as a regular pattern of cannabis use that causes performance difficulty at work, school and relationships (Hasin et al., 2013). A review of current treatments available for CUD indicate the lack of a pharmacological and psychological treatment with high success rates, which highlights the importance of exploring potential psychosocial interventions for the treatment of CUD. Given the evidence of psilocybin's therapeutic potential in the treatment of substance use disorders (de Veen et al., 2017), we aim to conduct a study using psilocybin-assisted-psychotherapy in the treatment of CUD. The study aims to evaluate the feasibility, safety, tolerability and potential therapeutic effect of 2 doses \[25 mg\] of psilocybin administered as part of an 8-week Motivational Enhancement Therapy (MET) and supportive therapy. This trial will be the first to evaluate the potential treatment effects of psilocybin on symptoms of CUD.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications, such as stimulants, anti-psychotic agents, benzodiazepines, and tri-cyclic anti-depressants. However, if you are on Selective Serotonin Reuptake Inhibitors or Serotonin Noradrenalin Reuptake Inhibitors, you can continue as long as your dose has been stable for 4 weeks and remains stable during the study.

What data supports the effectiveness of the drug psilocybin for treating cannabis use disorder?

Research suggests that psilocybin, a psychedelic drug, may help with various substance use disorders, including alcohol and smoking addiction. Although there is no direct study on cannabis use disorder, the positive outcomes in other addictions suggest potential benefits for cannabis use as well. ^{1 2 3 4 5}

Is psilocybin-assisted psychotherapy safe for humans?

The provided research articles do not contain specific safety data on psilocybin-assisted psychotherapy. However, they do mention that cannabis-based treatments for mental disorders have been associated with some side effects, though severe adverse effects were rare. More research is needed to provide reliable safety information. ^{6 7 8 9 10}

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

Psilocybin-assisted psychotherapy is unique because it uses psilocybin, a psychedelic compound, in controlled doses under medical supervision to potentially create long-lasting positive effects after just one or a few sessions, unlike traditional treatments that often require ongoing therapy or medication. ^{1 4 11 12 13}

Eligibility Criteria

This trial is for individuals aged 18-65 with Cannabis Use Disorder who want to reduce or stop cannabis use. They must be fluent in English, medically healthy as confirmed by tests, and have a stable residence during the study. Participants need to agree to protocol requirements and provide regular medical updates.

Inclusion Criteria

I have been diagnosed with a moderate or severe cannabis use disorder.

I am willing to follow the study's rules and requirements.

I can provide proof of my identity.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 doses of 25 mg psilocybin as part of an 8-week Motivational Enhancement Therapy (MET) and supportive therapy

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Psilocybin

Trial Overview The trial is testing psilocybin-assisted psychotherapy for treating Cannabis Use Disorder. It involves two doses of psilocybin (25 mg each) combined with an 8-week Motivational Enhancement Therapy program. The focus is on assessing feasibility, safety, tolerability, and potential therapeutic effects.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

This is an open-label single arm intervention trial. Participants in this arm will be offered both drug and psychotherapy as part of their 9-week intervention.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Center for Medicinal Cannabis Research

Collaborator

Trials

19

Recruited

630+

Peter Boris Centre for Addictions Research (PBCAR)

Collaborator

Trials

2

Recruited

40+

Findings from Research

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 study of 27 patients with moderate to severe major depressive disorder, psilocybin-assisted treatment showed significant and lasting antidepressant effects, with 75% of participants experiencing a treatment response and 58% achieving remission after 12 months.

There were no serious adverse events related to psilocybin, indicating a favorable safety profile, and participants reported meaningful personal and spiritual experiences that correlated with increased well-being, although these did not directly predict improvements in depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. Gukasyan, N., Davis, AK., Barrett, FS., 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]

A 28-year-old female with complex D-PTSD experienced a remarkable 98.5% reduction in dissociative symptoms after 10 sessions of cannabis-assisted psychotherapy (CAP) over 5 months, indicating strong efficacy for this novel treatment.

The patient not only no longer met the criteria for D-PTSD but also reported sustained improvements for over 2 years, suggesting that CAP may offer long-lasting benefits similar to those seen with classic psychedelics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis-assisted psychotherapy for complex dissociative posttraumatic stress disorder: A case report. Ragnhildstveit, A., Kaiyo, M., Snyder, MB., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. [2022]

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Systematic review and rationale of using psychedelics in the treatment of cannabis use disorder. [2023]

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

Psilocybin for alcohol use disorder: Rationale and design considerations for a randomized controlled trial. [2023]

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

Integrated Cognitive Behavioral Therapy for Comorbid Cannabis Use and Anxiety Disorders. [2020]

7. Egypt pubmed.ncbi.nlm.nih.gov

Prevalence of Cannabis Use Disorder and Associated Factors among Cannabis Young Adult Users at Shashemene Town, Oromia Region, Ethiopia, 2016. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Cannabis and Psychosis Through the Lens of DSM-5. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Cannabis-assisted psychotherapy for complex dissociative posttraumatic stress disorder: A case report. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

How effective and safe is medical cannabis as a treatment of mental disorders? A systematic review. [2020]

11. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

13. England pubmed.ncbi.nlm.nih.gov

Treatment of cannabis use disorders: a review of the literature. [2022]