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New treatment option for Cannabis Use Disorder, Moderate
Official title Psilocybin in the Treatment of Cannabis Use Disorder: A-Proof-of-Concept Study
ClinicalTrials.gov ID: NCT06225232
What this study is testing
What is Psilocybin combined with Psychotherapy?
Psilocybin combined with Psychotherapy is an investigational medicine, being studied as a potential treatment for cannabis use disorder, moderate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
- At Screening, meet criteria for CUD diagnosis of at least moderate severity as per the MINI Plus
You likely can't join if
- Meet DSM-5 criteria for lifetime history of bipolar disorder, schizophrenia, or other psychotic disorders, personality disorders, delirium, dementia...
- Have first-degree biological relatives (parents or full siblings) with past or present history of schizophrenia, bipolar disorder and any other...
- 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.
- Positive urine drug screen for substances tested with the exception of cannabis
- History of serotonergic psychedelic use in the past year and over 5 times of lifetime use (psilocybin, LSD, Ayahuasca, mescaline, DMT).
See the full eligibility criteria
- 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.
- At Screening, meet criteria for CUD diagnosis of at least moderate severity as per the MINI Plus
- Expressed a wish to reduce or stop cannabis use.
- Medically healthy based on physician review of CBC, electrolytes, liver function test, kidney function tests and ECG.
- Has a stable residence for the duration of the study.
- Agree to comply with the protocol requirements set out by the study.
- Consent to providing regular check-ins and follow-up regarding any medical conditions, procedures and adverse events.
- If of child-bearing potential, female participants must agree to use an adequate birth control method (IUD, injected or implanted hormonal methods, abstinence, vasectomy of the partner/partners, or double barrier...
- Following discharge from the dosing sessions, agree to have another individual accompany them home from the study site and stay with them overnight.
- 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...
- 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.
- Positive urine drug screen for substances tested with the exception of cannabis
- History of serotonergic psychedelic use in the past year and over 5 times of lifetime use (psilocybin, LSD, Ayahuasca, mescaline, DMT).
- Current treatment with psychotropic agents including stimulants, anti-psychotic agents, benzodiazepines and tri-cyclic anti-depressants. Concurrent treatment with Selective Serotonin Reuptake Inhibitors and Serotonin...
- History of cardiovascular diseases or uncontrolled hypertension that is not successfully treated or any other medical condition that might pose a risk to the participant in the opinion of the study physician.
- Are receiving concurrent psychotherapy for CUD.
- Are reasonably judged to present a serious suicide risk as determined by Columbia Suicide Severity Rating Scale or expressed homicide risk, who have enacted suicidal behaviors within 6 months prior to intake, or w ho...
- Participants of childbearing potential with a positive pregnancy test at screening or prior to dosing sessions, or are pregnant, breast feeding, and who are not using an acceptable means of birth control for the...
- Are unable to fully understand the potential risks and benefits of the study and give informed consent.
- Are currently or planning on participating in other treatment clinical trials during this study.
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.