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

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.