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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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.
MacAnxiety Research Centre
Hamilton, Ontario, Canada
RECRUITINGIncidence 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
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
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