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

ConditionsCannabis Use Disorder, Moderate Cannabis Use Disorder, Severe

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Psilocybin combined with Psychotherapy
Drug
The intervention consists of a 9-week treatment protocol that is based on supportive psychotherapy and Motivational Enhancement Therapy. Overall, the therapy course includes 8 motivational enhancement therapy sessions and two experimental drug sessions.

Treatment groups

16 Participants

are divided into 1 treatment group

Group A: Single ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence of spontaneously reported adverse events and serious adverse events from baseline to the nine-week endpoint

frequency, type and severity of outcomes are recorded

Time frame

9 weeks

Percent of recruited participants who discontinue or are lost to follow up before completing the 9-ween treatment protocol

frequency of cases of withdrawal and lost to follow up are documented and a percent is calculated based on the total number of participants recruited in this study.

Time frame

9 weeks

Secondary outcomes

Feasibility measured by number of individuals who express interest by contacting the study team, percent of individuals who are screened as eligible to those who contact the study, percent of those who complete the trial to those who are enrolled

Reported in frequency and percentages

Time frame

9 weeks

Efficacy a: frequency and amount of cannabis use, as measured by the Timeline Follow Back from baseline to the nine-week end point

This is measured using the Timeline Follow Back tool

Time frame

9 weeks

Efficacy b: Severity of symptoms associated with Cannabis Use Disorder as measured by Self-Reported Symptoms of Cannabis Use Disorder from baseline to 9 week endpoint

Self-Reported Symptoms of Cannabis Use Disorder

Time frame

9 weeks

Efficacy c: Changes in Urinary Cannabinoids from baseline to the nine-week endpoint

Urinary Cannabinoid Test

Time frame

9 weeks

Other outcomes

severity of symptoms of craving, withdrawal, anxiety, depression and functional impairment

Measured using Marijuana Withdrawal Checklist, Marijuana Craving Questionnaire, Patient Health Questionnaire - 9, Generalized Anxiety Disorder, Sheehan Disability Scale

Time frame

9 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

Center for Medicinal Cannabis Research

Collaborator

Peter Boris Centre for Addictions Research (PBCAR)

Collaborator

Source ClinicalTrials.gov

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