Can a psychedelic help break the cannabis habit?
NCT ID NCT06225232
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether psilocybin, the active compound in magic mushrooms, combined with psychotherapy can help adults with moderate to severe cannabis use disorder reduce or stop their cannabis use. Participants receive two doses of psilocybin alongside motivational enhancement therapy over nine weeks. The study focuses on safety, tolerability, and feasibility, while also exploring potential therapeutic effects. It is one of the first trials to examine psilocybin for this condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- psilocybin combined with psychotherapy
- What this could lead to
- If it works, this could point toward a new treatment option for cannabis use disorder, helping people reduce or stop cannabis use.
- What could go wrong
- This is a small, early-stage proof-of-concept study with only 16 participants, so results may not apply broadly. Psilocybin can cause temporary psychological effects, and the trial will closely monitor safety.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed Informed Consent Form. 2. Able to show documentation of identity. 3. Fluent in speaking and reading English and able to complete rating scales and assessments. 4. Between the ages of 18 to 65. 5. At Screening, meet criteria for CUD diagnosis of at least moderate severity as per the MINI Plus 6. Expressed a wish to reduce or stop cannabis use. 7. Medically healthy based on physician review of CBC, electrolytes, liver function test, kidney function tests and ECG. 8. Has a stable residence for the duration of the study. 9. Agree to comply with the protocol requirements set out by the study. 10. Consent to providing regular check-ins and follow-up regarding any medical conditions, procedures and adverse events. 11. 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 contraception i.e. condoms plus diaphragm, or diaphragm plus spermicide) for the duration of the study. Male participants should agree to using condoms with spermicide throughout the trial in addition to the use of an adequate contraceptive by their partner of childbearing potential. 12. Following discharge from the dosing sessions, agree to have another individual accompany them home from the study site and stay with them overnight. Exclusion Criteria: 1. 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. 2. Have first-degree biological relatives (parents or full siblings) with past or present history of schizophrenia, bipolar disorder and any other psychosis. 3. Meet DSM-5 criteria for panic disorder or seizure disorders. 4. Meet DSM-5 criteria for dependence of any substance other than cannabis or tobacco in the past 6 months. 5. Positive urine drug screen for substances tested with the exception of cannabis 6. History of serotonergic psychedelic use in the past year and over 5 times of lifetime use (psilocybin, LSD, Ayahuasca, mescaline, DMT). 7. 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 Noradrenalin Reuptake Inhibitors will be allowed, provided the dose has been stable for 4 weeks and remains stable during the study. 8. 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. 9. Are receiving concurrent psychotherapy for CUD. 10. 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 are likely to require psychiatric hospitalization during the study. 11. 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 duration of the study. 12. Are unable to fully understand the potential risks and benefits of the study and give informed consent. 13. Are currently or planning on participating in other interventional clinical trials during this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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MacAnxiety Research Centre
Hamilton, Ontario, L8S 1B8, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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