Psilocybin in the Treatment of Cannabis Use Disorder: A-Proof-of-Concept Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMcMaster University

About 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.

Eligibility criteria

Qualifiers

Signed Informed Consent Form.

Able to show documentation of identity.

Fluent in speaking and reading English and able to complete rating scales and assessments.

Between the ages of 18 to 65.

Disqualifiers

Meet DSM-5 criteria for lifetime history of bipolar disorder, schizophrenia, or other psychotic disorders, personality disorders, delirium, dementia and amnesic and other cognitive disorders, or are in a current agitated state.

Have first-degree biological relatives (parents or full siblings) with past or present history of schizophrenia, bipolar disorder and any other psychosis.

Meet DSM-5 criteria for panic disorder or seizure disorders.

Meet DSM-5 criteria for dependence of any substance other than cannabis or tobacco in the past 6 months.

Trial design

Treatments tested in this trial

  • Psilocybin combined with Psychotherapy

Treatment groups

16 Participants
are divided into 1 treatment group

Sponsors and collaborators

McMaster University

Lead sponsor

Center for Medicinal Cannabis Research

Collaborator

Peter Boris Centre for Addictions Research (PBCAR)

Collaborator